BHI Weekly Newsletter Archives Archives - Page 27 of 65

Aug 20 2020

Love0

417th Edition – August 4, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

August 4, 2020

FOUNDING MEMBER OF

Jennifer Butler, Executive Vice President and General Manager, Innate Pharma US Inc. sits down with Rich Bendis for BioTalk

Jennifer Butler, Executive Vice President and General Manager, Innate Pharma US Inc. joins Rich Bendis on BioTalk to discuss her career, bringing Innate from France to the US, and goals.

Listen now on Apple https://apple.co/3i30Bxs, Google https://bit.ly/2PkUw2U, Spotify https://spoti.fi/31gDh8n, TuneIn https://bit.ly/3fqn7i3, and YouTube Audio https://bit.ly/3kgU9ou.

Jennifer Butler was appointed Executive Vice President and General Manager of Innate Pharma US Inc. in March 2019.

Innate Pharma announces publication of EXPLORE COVID-19 translational study findings in Nature | Innate Pharma

Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the publication of a Nature paper entitled, “Association of COVID-19 inflammation with activation of the C5a-C5aR1 axis,” authored by Innate researchers in partnership with scientists from Hôpitaux Universitaires de Marseille AP-HM (La Timone and North Hospitals), Laveran Hospital, Aix Marseille University, the Centre d’Immunologie de Marseille-Luminy (Inserm, CNRS, AMU) and Marseille Immunopole/AP-HM immunoprofiling laboratory at La Timone Hospital.

This Marseille-based exploratory research taskforce, named EXPLORE COVID-19, analyzed immune cells in COVID-19 patients at different stages of the disease. The goal of the study was to gain translational insights to better understand the immune response in COVID-19 patients and identify potential targets to fight the viral infection.

Save the Date! 2020 BioHealth Capital Region Forum

This invitation-only event is free for executive level biotech leaders and is presented by BioHealth Innovation, Virginia Bio, Children’s National Health System, Johns Hopkins University, JPMorgan, Maryland Department of Commerce, George Mason University, University System of Maryland, Wilson Sonsini Goodrich & Rosati and AstraZeneca.

The BioHealth Capital Region—Maryland, Virginia, and Washington, DC—sets the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

BioFactura Awarded $1 Million SBIR Contract for Development of a Marburg Virus Therapeutic

FREDERICK, Md., July 29, 2020 /PRNewswire-PRWeb/ — BioFactura, Inc. today announced a $1 million Small Business Innovation Research (SBIR) Phase II contract awarded by the Joint Science & Technology Office—Chemical and Biological Defense (JSTO-CBD) of the Department of Defense (DoD). The goal of this project is to develop, optimize, and scale-up a highly efficient mammalian cell culture-based bioprocess suitable to meet surge requirement needs for rapid manufacture of a monoclonal antibody (mAb) therapeutic against the Marburg virus (MARV) biothreat.

Hopkins spinoff Thrive Earlier Detection Corp. raises $257 million funding round – Baltimore Business Journal

Johns Hopkins cancer diagnostics spinoff Thrive Earlier Detection Corp. has raised $257 million in new funding a little over a year after it closed another huge round.

Thrive launched in May 2019 with $110 million in funding for its cancer-detecting blood test developed by researchers at Johns Hopkins. That Series A round was remarkable for its size. It was the largest ever raised in support of a Hopkins-licensed technology, and among the largest raised by any firm co-based in the Baltimore area.

Image: https://www-bizjournals-com

Biobuzz Directory – HemoShear Therapeutics Receives FDA Fast Track and Rare Pediatric Disease Designations for HST5040 to Treat Methylmalonic Acidemia and Propionic Acidemia

Charlottesville, Va., July 28, 2020 – HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received Fast Track and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for HST5040, a once-daily oral small molecule drug being developed to treat methylmalonic acidemia (MMA) and propionic acidemia (PA).

In June, HemoShear received clearance from the FDA for its Investigational New Drug application to conduct a phase 2 clinical study of HST5040 in patients with MMA and PA. MMA and PA are rare genetic disorders caused by the deficiency of certain enzymes required to metabolize amino acids.

Johns Hopkins Receives $35M In Funding For COVID-19 Blood Plasma Trials – CBS Baltimore

BALTIMORE (WJZ) — Johns Hopkins researchers have received over $30 million in funding from the U.S. Department of Defense for two nationwide clinical trials to test the effectiveness of a convalescent blood plasma outpatient treatment.

The treatment is a transfusion of a blood product from COVID-19 survivors that contains antibodies that may help the patient’s immune system fight the virus, researchers say.

American Gene Technologies (AGT) Moves HQ to New Facility, Expands Lab Space for HIV and Cancer Cure Research – Across From National Cancer Institute Campus | American Gene Technology

ROCKVILLE, Md., July 28, 2020 — American Gene Technologies (AGT), an internationally recognized leading gene and cell therapy company in Rockville, Maryland, today announced it has leased a spacious, modern facility in the Maryland life sciences corridor, across from National Cancer Institute and Johns Hopkins Shady Grove Campus.

Image: https://www.americangene.com

NIH Invests $248.7 Million to Ramp up COVID-19 Testing

Six months into the COVID-19 pandemic, the question of why tests that detect the presence of the SARS-CoV-2 virus are not faster, better, and cheaper in this country still remains. Despite an incredibly complicated answer, the National Institutes of Health (NIH) has announced that they are going to help some companies work to develop their technologies, with the hope of getting over this roadblock. The program will give $248.7 million to seven biomedical diagnostic companies. The money is intended to support a range of new lab-based and point-of-care tests that, they hope, could significantly increase the number, type, and availability of tests by millions per week as early as September 2020.

TEDCO Announces New Executives | Maryland | curated.tncontentexchange.com

COLUMBIA, Md., July 28, 2020 /PRNewswire/ — TEDCO, Maryland’s economic engine for technology companies, announced today the appointments of Michael Hauser as the Managing Director of Investments and Terry Rauh as the Vice President, Chief Administrative Officer.

“Michael and Terry bring many years of leadership experience to fill these critical roles at TEDCO,” said Troy LeMaile-Stovall, TEDCO’s incoming CEO and executive director. “Leveraging their extensive knowledge of the Maryland business and innovation ecosystem, we’re looking forward to the impact they will make in fostering TEDCO’s mission.”

Image: Michael Hauser, TEDCO

Biotechnology draws $12.6B from private equity, venture capital activity in H1 | S&P Global Market Intelligence

Biotechnology led the healthcare industry in investment activity from private equity and venture capital during the first half of 2020, drawing nearly $12.60 billion in funding, up from $7.28 billion for the year-ago period.

The biotechnology sector either announced or concluded 342 deals globally as of June 30, comprising mergers and acquisitions and private placements, where the main investor was either a venture capitalist, a hedge fund manager or a private equity company, according to an analysis by S&P Global Market Intelligence.

Image: https://www.spglobal.com

Johns Hopkins Ranks 3rd In The Nation’s Best Hospitals List – CBS Baltimore

BALTIMORE (WJZ) — Johns Hopkins Hospital ranked no. 3 among the nation’s best hospitals, according to U.S. News & World Report.

The Best Hospitals List was released Tuesday with The Mayo Clinic earning the no. 1 overall ranking this year, followed by Cleveland Clinic at no. 2 out of 4,500 hospitals.

U.S. News & World Report also ranked 12 specialties at Hopkins among the top 10 in the country. Ear, Nose, and Throat, Neurology and Neurosurgery, Psychiatry, and Rheumatology ranked no. 1.

5 Questions with Jamie Lacey-Moreira, Principal and Founder, PressComm PR, LLC · BioBuzz

“5 Questions With……” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features Jamie Lacey-Moreira, Principal and Founder, PressComm PR, LLC.

EXCLUSIVE! A Personal Interview with Rita Colwell in Advance of Her Book “A Lab of One’s Own”

Rita Colwell is perhaps best known for her research on the pathogenic bacterium Vibrio cholerae. But the designation of pioneer is a label befitting Colwell for far-reaching contributions to many other areas, including her decades-long fight against sexism in a male-dominated field.

Colwell’s unique perspective on sexism in science is now able to be explored in her book, A Lab of One’s Own: One Woman’s Personal Journey Through Sexism in Science, which will be released on August 4th.

Opinion | Sputnik set off the Space Age. This virus can spark the Health Age. – The Washington Post

Regina E. Dugan is chief executive of Wellcome Leap, a nonprofit that seeks breakthroughs in human health. From 2009 to 2012, she served as director of the Defense Advanced Research Projects Agency.

The global pandemic is a hinge in history. Hundreds of thousands of lives lost globally; trillions in economic damage. It is as if the 1918 flu and the 1929 crash happened in the same year. It is the kind of event that alters the course of history so much that we measure time by it: before the pandemic — and after. It is a Sputnik moment.

Image: Astronaut Buzz Aldrin walks on the surface of the moon on July 20, 1969. (Neil Armstrong/NASA via AP)

SARS-CoV-2 Lurked for Decades Where Others Like It Lurk Still

Future pandemics—and suffering of the kind inflicted by COVID-19—could be avoided if we troubled ourselves to see where dangerous pathogens lie in wait. We could, two unrelated studies suggest, save ourselves untold woe and conserve our fortunes if we were to look into matters geographic, zoologic, and genomic. More specifically, we need to keep our eyes wide open when we venture into the planet’s last wild places. There, we may run into wild animals that are infected with pathogens harboring wild genetic traits—which is to say, genetic traits that evolved naturally, beyond our gaze, and that waited patiently, perhaps decades, for a chance to strike.

Illumina Accelerator Grant Competition

Now Accepting Rolling Grant Applications

The Illumina Accelerator Sequencing Grant Competition encourages entrepreneurs to build startups using next-generation sequencing. Awarded grant winners have the opportunity to spend one week at Illumina Accelerator in the San Francisco Bay Area to run proof-of-concept sequencing experiments. It’s a great way to learn more about each other and to help advance your genomics-driven startup.

Aug 20 2020

Love0

416th Edition – July 28, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

July 28, 2020

FOUNDING MEMBER OF

BioFactura, Inc. Co-Founder, President & CEO, Darryl Sampey, PH.D., Virtually Sits Down with Rich Bendis for BioTalk

BioFactura, Inc. Co-Founder, President & CEO, Darryl Sampey, PH.D., joins BioTalk to discuss his background with the University of Maryland, the BioHealth Capital Region, and the creation of his company in Frederick.

Listen now via Google https://bit.ly/3hz2jpU, Apple https://apple.co/3eYLiUs, Spotify https://spoti.fi/3f3cqBU, TuneIn https://bit.ly/302voUG, and YouTube (Audio Only) https://bit.ly/3f3cQZ0

Emergent BioSolutions Signs Agreement with AstraZeneca to Expand Manufacturing for COVID-19 Vaccine Candidate NYSE:EBS

GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials and an initial capacity reservation.

“Emergent is driven by our desire to advance solutions that will make an impact on this pandemic,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “Sharing a passion for science, we are encouraged by AstraZeneca’s investigational COVID-19 vaccine and look forward to supporting its continued progress.”

Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate

GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 /PRNewswire/ — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. FDB’s site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373.

Altimmune Announces Manufacturing Agreement with Vigene Biosciences for AdCOVID™, its Single Dose Intranasal Vaccine Candidate for COVID-19 Nasdaq:ALT

GAITHERSBURG, Md., July 22, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the Company has entered into an agreement with Vigene Biosciences (“Vigene”) to manufacture AdCOVIDTM, Altimmune’s single-dose intranasal vaccine candidate for COVID-19. Vigene, a Rockville, Maryland-based award-winning Contract Development and Manufacturing Organization (CDMO), specializes in viral vectors and will deploy its capabilities to manufacture AdCOVID. Following recent positive pre-clinical data, Altimmune plans to start a Phase 1 clinical trial of AdCOVID in Q4 2020.

“Vigene is a fantastic partner to advance AdCOVID into Phase 1 clinical testing and beyond,” said Dr. Vipin K. Garg, President and CEO of Altimmune. Dr. Garg continued, “We believe Vigene’s deep experience in viral vector production and their collaborative, client focused approach will help facilitate Altimmune’s timeline for clinical development of AdCOVID.”

TEDCO names Troy LeMaile-Stovall as next CEO – Technical.ly Baltimore

TEDCO, Maryland’s state-backed agency that supports early-stage tech companies, has named Troy LeMaile-Stovall as its next CEO.

Lemaile-Stovall, who is currently COO of the University of the District of Columbia (UDC) and leads a management consulting firm, will start in the role on Sept. 7. He was introduced at a virtual press conference on Wednesday, where he spoke about leadership in a time that includes a pandemic, economic downturn and a nationwide push for racial justice. While we’re still in the midst of what could be long-term shifts taking place, he said he was “excited about how we move from economic development to economic empowerment for all of the citizens of Maryland.”

Image: Troy Lemaile-Stovall will begin as CEO of TEDCO in September. (Courtesy photo)

CASI Pharmaceuticals Announces Proposed Public Offering Of Common Stock

ROCKVILLE, Md. and BEIJING, July 21, 2020 /PRNewswire/ — CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the offering, CASI expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. There can be no assurances as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock in the offering will be sold by CASI.

Serpin Pharma Receives FDA Approval for COVID-19 Clinical Investigation

Manassas, VA – On June 17, 2020, Serpin Pharma was notified by the U.S. Food and Drug Administration (FDA) that it may proceed with its proposed clinical investigation for the use of SP16 to treat COVID-19 hospitalized patients. The Principal Investigator is Serpin Pharma’s collaborator,

Dr. Michael Yun Shim, John L. Guerrant Assoc. Professor of Medicine and Medical Imaging, Div. of Pulmonary & Critical Care of the University of Virginia. Dr. Larry Altstiel, acting Chief Medical Officer for Serpin Pharma, said, “SP16 is a potent new antiinflammatory drug rather than a non-specific, toxic immunosuppressive drug. SP16 reduces the production of inflammatory cytokines (e.g., IL-1β, TNF-α, IL-6) while sparing normal and protective immune function. It is effective in several animal models of acute inflammation, in particular, following a severe lung infection. Therefore, SP16, by its ability to inhibit excess cytokine production, may attenuate the development of inflammation-induced lung injury in individuals with COVID-19 infection.”

Save the Date! 2020 BioHealth Capital Region Forum (2)

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

Emergent Bio inks deal with AstraZeneca for manufacture of COVID-19 vaccine (NYSE:EBS) | Seeking Alpha

Emergent BioSolutions (NYSE:EBS) has signed an agreement with AstraZeneca (NYSE:AZN) to provide contract development and manufacturing (CDMO) services for large-scale drug substance manufacturing for AZN’s COVID-19 vaccine candidate, AZD1222.

4 Key Insights for Startups and Entrepreneurs Looking to Grow a Life Science Business · BioBuzz

Driven entrepreneurs and savvy startup leaders participated in the recent “Fueling an Innovation Ecosystem for Startups to Thrive” webinar that featured prominent connectors and innovators from the BioHealth Capital Region (BHCR). The virtual event was sponsored by WorkForce Genetics and covered a wide range of topics including the pandemic, critical regional resources for startups, advice for approaching investors and a list of the biggest mistakes made by entrepreneurs when seeking funding.

TruGenomix just won Start Up of the Year Pitch Event

Excited to announce that TruGenomix just won Start Up of the Year Pitch Event. Great pitch Charles Cathlin !!!!! #SDVOB #ptsd #TruGenomix #veteranshelpingveterans

Sanford Health and TruGenomix announce partnership to commercialize genomic test for PTSD

SIOUX FALLS, S.D., July 23, 2020 /PRNewswire/ — Sanford Health, the largest provider of rural healthcare in the country, today announced an $800,000 investment in TruGenomix, a veteran-owned precision behavioral health company.

As part of the strategic partnership, Sanford Health will support TruGenomix by providing its state-of-the-art lab and research capabilities to validate a first-to-market patented blood test for post-traumatic stress disorder (PTSD). The genomic test enables earlier identification and improves outcomes for high-risk populations, including veterans, active-duty service members, frontline health care workers, and first responders.

Cerecor Announces First Patient Enrolled in Multicenter Proof-of-Concept Study Evaluating CERC-002 for COVID-19 ARDS Nasdaq:CERC

ROCKVILLE, Md., July 21, 2020 (GLOBE NEWSWIRE) — Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare pediatric and orphan diseases, today announced the first patient has been enrolled in a proof-of-concept trial evaluating the safety and efficacy of the anti-LIGHT monoclonal antibody, CERC-002, in patients with COVID-19 cytokine storm-induced Acute Respiratory Distress Syndrome (ARDS).

The proof-of-concept, randomized, multicenter, double-blind, placebo-controlled trial will enroll approximately 82 subjects hospitalized with COVID-19 ARDS. The primary objective of the study is to demonstrate that treatment with CERC-002 results in fewer instances of respiratory failure and death versus the standard of care. Patients in the CERC-002 arm will receive a single dose of drug and be followed for 28 days. Key secondary endpoints include intensive care unit (ICU) length of stay, hospital length of stay, and oxygen saturation at the end of the study. Top-line data are expected in the fourth quarter of 2020.

JHTV Contracts Team Finds Extra Meaning in Supporting Researchers’ COVID-19 Work | Johns Hopkins Technology Ventures

Virologist Andrew Pekosz has a team of 15 people working around the clock in his lab at the Johns Hopkins Bloomberg School of Public Health supporting work on a potential treatment for COVID-19. Pekosz’s lab is testing the blood of coronavirus survivors for plasma antibodies that researchers think might help treat critically ill coronavirus patients.

Image: Nekeshia Maloney, JHTV’s director of contracts

Vita Therapeutics receives Orphan Drug Designation from FDA for new novel treatment

BALTIMORE, July 23, 2020 /PRNewswire/ — Vita Therapeutics, Inc. announced today that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne’s Muscular Dystrophy (DMD).

VTA-110, is a potential first-in-class allogenic iPSC-based therapy that has shown the ability to repair and regenerate healthy muscle in preclinical studies and has the potential to benefit patients with DMD. The company plans to continue to progress this treatment towards clinical trials and plans to bring it forward for other congenital muscular dystrophy diseases as well. This therapy was exclusively licensed from technology originally invented at Johns Hopkins University and the Kennedy Krieger Institute in the labs of Dr. Kathryn Wagner and Dr. Gabsang Lee.

“COVID-19 edition” of pediatric medical device

WASHINGTON – (July 22, 2020) – The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces eight winners chosen in its special COVID-19 edition of the “Make Your Medical Device Pitch for Kids!” competition. Focused on innovations in COVID-19-related pediatric medical devices that will improve children’s health care, 16 finalists competed on Monday, July 20 in a virtual pitch event for a share of $250,000 in total grant awards.

Image: Judges award grants for pediatric medical devices that address COVID-19-related needs – https://www.openpr.com

AstraZeneca mines another $6B ADC from Daiichi Sankyo, with blockbuster ambitions to ‘redefine treatment standards’ – Endpoints News

Pascal Soriot isn’t letting the all-consuming R&D and manufacturing work on a Covid-19 vaccine slow down his hunt for AstraZeneca’s next blockbuster cancer drugs.

The latest deal with Daiichi Sankyo consists of $1 billion in upfront cash payment spread over 2 years: $350 million upon completion, and $325 million each at the 12-month and 24-month mark. Regulatory milestones add up to another $1 billion while sales-related fees tot up to $4 billion.

Maryland VC funding defies dire pandemic predictions, rises in Q2 – Technical.ly Baltimore

When it comes to Maryland companies, the pandemic isn’t slowing down venture capital funding.

Data from the latest MoneyTree report by PricewaterhouseCoopers/CB Insights shows that Maryland companies collectively received $358 million in venture capital funding for the second quarter of 2020, marking a big uptick in dollars over the prior quarter even amid a global pandemic and economic downturn.

Image: Looking up in Harbor East. (photo by Wikimedia Commons user Bohemian Baltimore, obtained under a Creative Commons license.)

Incoming international students must remain abroad despite visa rule reversal – The Johns Hopkins News-Letter

“Today, we feel forgotten. Everyone believes we still won. The class of 2024 didn’t win. After calls and emails, we’re met with another unyielding reality: we can’t come to campus.”

These are the words of an open letter circulating among international students of the class of 2024 asking for Hopkins to advocate for them.

Last week, the Trump administration abruptly dropped its plans to ban international students taking online-only courses from residing in the U.S. Given that instruction at Hopkins will go fully online following Thanksgiving break, international students at Hopkins would not have been able to return to campus for any portion of the semester had the rule stayed in place.

Image: CC BY-NC-SA 2.0 Most incoming international students will not be able to enter the United States this fall.

University System of Maryland chancellor describes rationale for fall plans | WTOP

Since May, the University System of Maryland has said that remote learning and in-person classes will return in the fall. It recently explained why it is sticking with that model.

“Opting for a hybrid model — combining in-person and remote learning — is, by no stretch, an easy out. It doesn’t save us money, it doesn’t save us time, it doesn’t save us planning. It’s a high-cost, high-effort undertaking,” Chancellor Jay A. Perman said in a statement.

However, it is choosing the model because he said there are students who need the campus environment.

Alexandria LaunchLabs – Only Two Small Labs Left!

Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

In conversation with Vaccitech CEO Enright on pandemic vaccines | FierceBiotech

Vaccitech is a spinout company from the University of Oxford’s Jenner Institute, one of the oldest and most renowned vaccine research centers in the world.

You probably haven’t heard of them, but they are now working alongside AstraZeneca on a COVID-19 vaccine the World Health Organization believes is leading the race in creating an inoculation against SARS-CoV-02.

Data posted this month from just over 1,000 patients in a phase 1/2 trial showed it to be broadly effective in creating an immune response, though many questions remain and a series of bigger, late-stage tests is necessary to find those answers out.

Image: Bill Enright, Vaccitech CEO (Vaccitech)

AstraZeneca chief helps Deloitte launch Life Sciences Catalyst in Cambridge | Business Weekly | Technology News | Business news | Cambridge and the East of England

Deloitte has launched the Life Sciences Catalyst in Cambridge, a collaborative platform enabling organisations in the biotech, medtech, pharmaceutical and technology sectors, as well as prospective investors, to come together to tackle the biggest challenges facing their industries.

The Life Sciences Catalyst will facilitate connections between people, businesses and investors to support companies with their growth, regardless of their evolutionary stage.

What Safe Shopping Looks Like During the Pandemic

To limit the spread of Covid-19, the U.S. Centers for Disease Control and Prevention recommends that individuals practice social distancing. When local conditions allow for retail stores to open, they confront a variety of guidelines that vary by state. For example North Carolina places specific limits on the number of customers allowed per square foot, while Oregon generally advises that the number of customers in the store should be limited so that customers can remain six feet apart. Whether or not customers are required by law to wear masks in stores depends on the state. How retailers implement these guidelines also varies among types of retailers and even within store categories. Grocery stores, for example, have adopted a wide variety of specific methods to ensure that customers remain apart.

D.C. imposes self-quarantine for travelers from 27 states – Washington Business Journal

D.C. is requiring people making travel into Washington from 27 states to self-quarantine because of new surges in Covid-19 cases.

The order went into effect Monday.

KidneyX Summit Announces Winners of the Redesign Dialysis Phase 2 Prize | Kidney News

Today, July 22nd, a virtual summit was hosted by KidneyX to announce the six winners of the Redesign Dialysis Phase 2 prize. The goal of the Redesign Dialysis prize is to provide prize money for novel ideas and innovations that will lead to better outcomes for people with kidney diseases and eventually to a truly artificial kidney. The eventual artificial kidney and innovations made along the way will lead to better outcomes for individuals with kidney diseases and improve their quality of life by bypassing in-center hemodialysis.

Undergraduate Scholarships

Each scholarship is a one-time award; however previous applicants and past scholarship recipients are eligible to re-apply. Full-time, part-time, online and distance learning programs are acceptable. Scholarships are for college-degree programs only and may not be used to attend professional development seminars.

By accepting a scholarship, you are consenting to allow the SHRM Foundation (and the award’s sponsor, if any) to use without limitation, and in any media, your name, city, state, photos, and captions (if uploaded), and verbiage for marketing and promotional purposes.

Employees or board members of SHRM or the SHRM Foundation and members of their immediate family are not eligible to apply for SHRM Foundation grants, awards or scholarships.

The SHRM Foundation does not discriminate against individuals on the basis of race, color, gender, sexual orientation, marital status, religion, disability, age, veteran status, ancestry, national origin or citizenship in the administration of its scholarship programs. Scholarship recipients are selected primarily on merit.

SHYCOCAN – A Device to Disable Coronaviruses – to be Marketed Under US-FDA’s Enforcement Discretion During the COVID-19 Public Health Emergency | BioSpace

GAITHERSBURG, Md., July 23, 2020 /PRNewswire/ — Shreis Scalene Therapeutics LLC (SSTx), a MD-USA-based medical device company will fast-track the manufacture and distribution of the CE-marked (EU-Class 1) Scalene Hypercharge Corona Canon (SHYCOCAN) under US FDA ‘Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

Aug 20 2020

Love0

415th Edition – July 21, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

July 21, 2020

FOUNDING MEMBER OF

Save the Date! 2020 BioHealth Capital Region Forum

For more information about our speakers and event schedule, please visit www.biohealthcapital.com/forum-2020

#BHCRForum20

AstraZeneca, U. of Oxford Report Positive Phase I/II Data for COVID-19 Vaccine Candidate

Researchers from AstraZeneca, the University of Oxford, and its spinout company Vaccitech today published preliminary Phase I/II data showing their closely-watched COVID-19 vaccine candidate AZD1222 (formerly ChAdOx1 nCoV-19) to have an acceptable safety profile, and favorable immunogenicity against the virus.

“A single dose elicited both humoral and cellular responses against SARS-CoV-2, with a booster immunization augmenting neutralizing antibody titres. The preliminary results of this first-in-human clinical trial supported clinical development progression into ongoing phase 2 and 3 trials,” the researchers concluded in Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial, published today in The Lancet.

Creatv MicroTech Aims to Detect Patient Immune Cells for Cancer Drug Response Prediction

NEW YORK – Liquid biopsy firm Creatv MicroTech is developing a diagnostic platform that measures the amount and size of specific circulating stromal cells called cancer-associated macrophage-like cells (CAMLs) to identify traces of cancer in a patient’s bloodstream.

The Potomac, Maryland-based company initially plans to commercialize the method, called LifeTracDx, to predict immunotherapy response in stage II to III non-small cell lung cancer (NSCLC) cancer patients.

Leading through Change and Resilency Classes Available Through MC

Montgomery College announces several pop-up, remote classes which could be valuable for you and your teams: :

Sustaining Resilience MGT632 (crn#16869), August 5, 2020,
Leading Through Change, MGT633 (crn#16870), August 14, 2020
Strengthening Effective Communication, MGT634 (crn#16871), August 19, 2020

All three classes are structured remote from 8:30 a.m. to 12:30 p.m. and cost only $129.

Course descriptions may be found on the Summer 2020 Popup Classes Flyer (PDF, Get Adobe Acrobat PDF Reader.-Link opens in new window.) .

Registration information may be found at WDCE Registration Options.

BARDA upgrades Emergent pact with $258M option for anthrax vaccine stores | FiercePharma

Drugmakers around the world are scrambling to develop a COVID-19 shot, and Emergent BioSolutions has already signed on to help produce doses for some major players. Now, the Gaithersburg, Maryland-based biopharma has scored a contract update to deploy future vaccine doses for a wholly different kind of health crisis.

Image: Emergent launched a phase 3 trial on NuThrax in March last year; that study is on track to finish by the year’s end. (FiercePharma) – https://www.fiercepharma.com

Altimmune making headway with Covid-19 programs – Washington Business Journal

Altimmune Inc. is making progress on its Covid-19 vaccine more than four months after jumping into that arena.

The Gaithersburg biopharma said Monday it has emerged from preclinical trials with positive results, positioning the clinical-stage company to start manufacturing the candidate, called AdCovid, in the third quarter of this year and start a phase 1 clinical trial in the fourth quarter.

Image: Dr. Vipin Garg is president and CEO of Altimmune. COURTESY ALTIMMUNE

citybizlist : Washington DC : “COVID-19-Edition” of Pediatric Medical Device Competition Announces Finalists

Sixteen finalists are announced in the “Make Your Medical Device Pitch for Kids!” special COVID-19 edition competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in COVID-19-related pediatric medical devices, the finalists will compete in a virtual pitch event held on July 20,2020. Winners will receive grant awards of up to $50,000.

These 6 pandemic response apps won the University System of Maryland’s COVID App Challenge – Technical.ly Baltimore

Facial temperature detection, campus heatmaps: They’re among the tools in a collection of apps created by teams from within the University System of Maryland over the last month to help limit the spread of COVID-19 — and navigate a society that has changed quickly in the pandemic.

In all, six apps were selected as winners of the USM COVID App Challenge, which was issued at the end of May to galvanize the creation of new tools to respond to the pandemic.

Image: AnTech, developed by Andrew Karam of University of Maryland College Park. (Screenshot via YouTube/AnTech)

Emergent BioSolutions invests $75M in viral vector, gene therapy capabilities – Homeland Preparedness News

Emergent BioSolutions revealed this week plans to expand its viral vector and gene therapy capabilities.

The company announced it will invest $75 million in its Canton, Mass., facility, which is focused on the contract development and manufacturing (CDMO) of drug substances for live viral vaccines, including the company’s smallpox vaccine

Innate Pharma announces the appointment of Joyson Karakunnel, MD, MSC, FACP as Chief Medical Officer | Innate Pharma

Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the appointment of Dr. Joyson Karakunnel as Executive Vice President and Chief Medical Officer (CMO). Dr. Pierre Dodion, CMO since 2014, is retiring from this position.

Dr. Karakunnel comes to the Company with deep experience in immuno-oncology, and a proven track record in drug development. As CMO, he will be responsible for advancing Innate’s clinical pipeline and will lead a global team focused on clinical strategy, patient safety, regulatory and medical affairs.

WEBINAR: Fueling an Innovation Ecosystem For Startups To Thrive – YouTube

A lively discussion between our region’s top innovators and connectors to hear about their efforts to help grow the innovation ecosystem and the pipeline of successful startups across the BioHealth Capital Region.

https://www.youtube.com/watch?v=Dn51Ga8jLrI&feature=youtu.be

5 Questions with Sara Nayeem, M.D., a Partner at New Enterprise Associates (NEA) · BioBuzz

“5 Questions With……” is a weekly BioBuzz series where we reach out to interesting people in the BioHealth Capital Region to share a little about themselves, their work, and maybe something completely unrelated. This edition features Sara Nayeem, M.D., a Partner at New Enterprise Associates (NEA)

Life-Science Real Estate Booming Amid Pandemic – The Real Deal

The search for a cure for Covid-19 is lining the pockets of some landlords.

While the pandemic wreaks financial havoc on hotels and retailers, landlords who cater to biotech and pharmaceutical tenants are seeing increased demand as companies research treatments for the coronavirus, according to the Wall Street Journal. The work of those tenants, too, is more difficult to replicate in a work-from-home setup than the typical office employee.

Inno on Fire: The most innovative companies, people in Greater Washington – Washington Business Journal

The finalists are sourced from nominations and editorial coverage, and selected by the DC Inno team.

Digital Health Ecosystem Report: Startups & Companies in 2020 – Business Insider

Healthcare stakeholders can no longer lag on digital transformation, and tapping into innovation can sate convenience-hungry consumers and tackle some massive challenges compressing their bottom lines.

Personalization and convenience have become table stakes in nearly every industry, and consumers are extending demands for these digital-powered experiences to healthcare — US consumers have expressed a willingness to jump ship to care services that can provide them with better digital experiences.

Image: Business Insider Intelligence

What to expect at this CBA Annual Conference

The theme of the 25th CBA Annual (Virtual) Conference is “Innovations amid Crisis: A Productive Year of Biopharma Industry”. We will invite biopharmaceutical industry leaders, regulatory and scientific experts from US, China, and Canada to discuss recent research advances on COVID-19, and new trends in biopharma industry. The detailed conference program will be available at www.cba-usa.org shortly.

Time:

Day 1: 8 am – 11 am (EST), August 29th, 2020 (Saturday)

Day 2: 8 am – 11 am (EST), August 30th, 2020 (Sunday)

Registration link: https://bit.ly/2WfpRrR

Eight Drivers that Will Define Digital Health in the 2020s | by Robert Lord | LionBird | Jul, 2020 | Medium

As we embark on our third fund at LionBird, we believe that proactively thinking deeply about what will drive the next decade of healthcare will help us both filter through the noise of digital health, and quickly identify the right investment opportunities. We believe that 2020 represents an unprecedented inflection point in digital health (due to both the COVID-19 global pandemic, as well as many other factors) and we aim to define the trends for the coming decade and their implications for our investment strategy.

House Committee Votes for $5.5B Boost to NIH Budget | GenomeWeb

NEW YORK — The US House of Representatives Appropriations Committee on Monday approved a roughly $5.5 billion increase in funding for the National Institutes of Health in fiscal 2021, with budget increases for every institute and center.

The committee recommended a total of $46.96 billion in NIH funding for FY 2021, representing a nearly 13 percent increase over its current $41.68 billion budget. Earlier this year, President Donald Trump called for trimming the NIH’s FY 2021 budget to $38.37 billion.

How America’s Unique Approach To Innovation Can Cure COVID-19

Scientists have responded to COVID-19 with unprecedented speed. Just months after the outbreak of the novel coronavirus, clinical trials are already underway for nearly 200 vaccines and therapies.

But while the pace of COVID-19 innovation may be extraordinary, the research infrastructure allowing this remarkable work is hardly new. In fact, it was cemented into place nearly two generations ago when Congress passed the Bayh-Dole Act of 1980.

How Verona Pharma in Raleigh plans to use $200 million raise – Triangle Business Journal

The raise is one of the biggest in the Triangle since last year.

NJEDA Approves $12M in Investments Through Angel Investor Tax Credit Program – New Jersey Business Magazine

Fourteen businesses in New Jersey’s technology, life sciences, and clean energy sectors received a combined $12.3 million from 50 investments approved through the state’s Angel Investor Tax Credit Program during the first half of 2020, the New Jersey Economic Development Authority (NJEDA) announced yesterday. Two of the approved companies benefited from legislation signed by Gov. Phil Murphy last year expanding the program.

Jul 14 2020

Love0

414th Edition – July 14, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

July 14, 2020

FOUNDING MEMBER OF

Fueling an Innovation Ecosystem for Startups to Thrive – Tune In Today – Bendis to Moderate

BHI’s own Rich Bendis will Moderate.

Join us for a lively discussion between our region’s top innovators and connectors to hear about their efforts to help grow the innovation ecosystem and the pipeline of successful startups across the BioHealth Capital Region.

On this webinar, you will learn how you can take advantage of the many resources available throughout the region that will help your company go to market AND increase the opportunity to find success in the process.

Fueling an Innovation Ecosystem for Startups to Thrive

Click here for more information and to register.

U.S. government awards Novavax $1.6 billion for coronavirus vaccine | News | 1450 99.7 WHTC

CHICAGO (Reuters) – The U.S. government has awarded Novavax Inc $1.6 billion to cover testing and manufacturing of a potential vaccine for the novel coronavirus in the United States, with the aim of delivering 100 million doses by January.

The award announced by the U.S. Department of Health and Human Services is the biggest yet from “Operation Warp Speed,” the White House initiative aimed at accelerating access to vaccines and treatments to fight COVID-19, the respiratory disease caused by the coronavirus.

Mount Sinai Health System, Emergent BioSolutions, and ImmunoTek Bio Centers Form Collaboration to Develop Emergent’s COVID-19 Hyperimmune Globulin (COVID-HIG) Product Candidate with U.S. Department of Defense Funding | Emergent BioSolutions Inc.

NEW YORK and GAITHERSBURG, Md. and NEW ORLEANS and LAFAYETTE, La., July 08, 2020 (GLOBE NEWSWIRE) — The Mount Sinai Health System, Emergent BioSolutions (NYSE: EBS), and ImmunoTek Bio Centers today announced that they will collaborate to develop, manufacture, and conduct clinical trials to evaluate Emergent’s COVID-19 hyperimmune globulin product, COVID-HIG, including a post-exposure prophylaxis (PEP) study on health care providers at high risk of COVID-19 infection and other high-risk populations, with $34.6 million in funding from the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).

REGENXBIO Provides Update on Progress of Clinical Programs for Rare Genetic Neurodegenerative Diseases

ROCKVILLE, Md., July 8, 2020 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it has completed dosing of three patients in Cohort 2 of the Company’s Phase I/II study of RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II) and reported encouraging data under a single-patient investigator-initiated Investigational New Drug (IND) application for RGX-111 for the treatment of Mucopolysaccharidosis Type I (MPS I) conducted at CHOC Children’s.

APEIRON Biologics and MaxCyte Enter into Clinical and Commercial Licensing Agreement for APN401

VIENNA, AUSTRIA and GAITHERSBURG, MD, July 8, 2020 APEIRON Biologics AG (“APEIRON”), a private biotechnology company specializing in the discovery, development and commercialization of novel immunotherapies for cancer and respiratory diseases, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announces the signing of a clinical and commercial licensing agreement.

APEIRON Biologics will obtain non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform for the advancement of APN401, a siRNA-based cell therapy currently in clinical development for various solid tumors. In return, MaxCyte will receive undisclosed development and approval milestones and sales-based payments in addition to other licensing fees.

First Published Clinical Trial Using Live Biotherapeutic Candidate In COVID-19 Patients Suggests Role In Improving Outcomes – MarketWatch

ROCKVILLE, Md., July 13, 2020 /PRNewswire via COMTEX/ — ROCKVILLE, Md., July 13, 2020 /PRNewswire/ — ExeGi Pharma LLC, a U.S.-based company focused on developing and commercializing products targeting the human microbiome, including live biotherapeutic products (LBPs), announced today the results of a 70-patient clinical trial evaluating a new biologic drug candidate in hospitalized COVID-19 patients. The study was conducted in a hospital setting in Rome and published in the peer-reviewed journal Frontiers in Medicine. It compared outcomes of patients who received standard drug treatments alone or standard treatments combined with an oral bacteriotherapy.

Alexandria Real Estate Equities, Inc. Announces Pricing Of Upsized Public Offering Of 6,000,000 Shares Of Common Stock

PASADENA, Calif., July 6, 2020 /PRNewswire/ — Alexandria Real Estate Equities, Inc. (“Alexandria” or the “Company”) (NYSE: ARE) today announced the pricing of its upsized public offering of 6,000,000 shares of the Company’s common stock at a price of $160.50 per share in connection with the forward sale agreements escribed below. The Company also granted the underwriters a 30-day option to purchase up to 900,000 additional shares. The offering is expected to close on or about July 9, 2020, subject to customary closing conditions.

Montgomery County’s unique biohealth and life science organizations are working to test, beat and cure COVID-19 | WTOP

While COVID-19 has thrown the world into an uproar, there’s been a slim silver lining for Maryland. Thanks to a robust group of biohealth and life science organizations, Montgomery County has a unique opportunity to help people nationwide — and worldwide — in the fight against the disease.

As a resident, you may not realize just how much Montgomery County does to help in biohealth across the country.

To start, there is the National Institutes of Health, which hardly needs an introduction, what with its many contributions to medicine throughout the world for more than a century. Just in April, the NIH launched the Accelerating COVID-19 Therapeutic Interventions and Vaccines partnership to coordinate — and hopefully accelerate — research on a vaccine.

GSK and Medicago announce collaboration to develop a novel adjuvanted COVID-19 candidate vaccine | GSK

GSK and Medicago today announced a collaboration to develop and evaluate a COVID-19 candidate vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. CoVLPs mimic the structure of the virus responsible for COVID-19 disease, allowing them to be recognised by the immune system. Use of an adjuvant can be of particular importance in a pandemic situation as it may boost the immune response and reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people.

Johns Hopkins statement re: SEVP lawsuit filed today

BALTIMORE, July 10, 2020 /PRNewswire/ — Johns Hopkins University filed suit in federal court Friday in an effort to stop a Trump administration rule change that would severely impact nearly 5,000 international students at the university. The decision to abruptly rescind accommodations for online learning during the COVID pandemic is unlawful and fails to consider the many complexities of meeting our educational mission while also protecting the health of our community.

The suit was filed in the Federal District Court for Washington, D.C., which has significant expertise in handling challenges against unlawful action by the federal government, and it joins other litigation related to the new rule filed by Harvard, MIT and the University of California. Johns Hopkins’ plans for a hybrid, online/in-person model for some of its divisions presents the broadest array of issues for the courts to consider.

Johns Hopkins’ Covid-19 map: Meet the team behind the leading resource – CNN

(CNN) – If the year 2020 is good for anything, it’s the lesson that during a crisis, anyone who builds a better mousetrap will find the world beating a path to his door.

A humble team at Johns Hopkins University in Maryland reminded the world of late poet Ralph Waldo Emerson’s phrase when they created a real time tracking map of coronavirus cases and deaths.

And the world came to their door. They report that the site, plus downloads of its data, hosts three to five billion interactions daily. By their measurement, interactions include uses of the public dashboard and requests from a separate website for the underlying data used by news outlets and others who design their own maps and graphics.

Image: Civil engineering professor Lauren Gardner, of the Center for Systems Science and Engineering at Johns Hopkins University, is the lead behind the dashboard project.

Commentary: Washington wants to forfeit our best weapon against coronavirus | Columnists | elkodaily.com

Rep. Jan Schakowsky (D-IL) and several senior House lawmakers recently announced a plan to impose price controls and seize patents on any COVID-19 vaccines and treatments in development. They vowed to strike down any emergency stimulus packages excluding such measures.

Those efforts aren’t just misguided — they pose a threat to the health of Americans. If lawmakers succeed, they would dismantle the innovation ecosystem that has enabled U.S. pharmaceutical firms to move with remarkable speed to develop COVID-19 vaccines and treatments.

Meet the Researcher Leading NIH’s COVID-19 Vaccine Development Efforts – Government Executive

Asafe, effective vaccine is the ultimate tool needed to end the coronavirus disease 2019 (COVID-19) pandemic. Biomedical researchers are making progress every day towards such a vaccine, whether it’s devising innovative technologies or figuring out ways to speed human testing. In fact, just this week, NIH’s National Institute of Allergy and Infectious Diseases (NIAID) established a new clinical trials network that will enroll tens of thousands of volunteers in large-scale clinical trials testing a variety of investigational COVID-19 vaccines.

Image: DR. FRANCIS COLLINS Director of the National Institutes of Health (NIH) – https://www.govexec.com

Johns Hopkins calls new federal rules for international students ‘disturbing’ and ‘draconian’ – Baltimore Business Journal

Hopkins has the highest percentage of international students of any Maryland college.

Where Providence Ventures is investing millions — 17 portfolio companies including Protenus

Providence Ventures was founded in 2014 and manages $300 million of venture capital in two funds.

The company is affiliated with Providence, a 51-hospital health system that has more than 800 clinics in five states. The fund makes direct investments in healthcare companies with the goal of improving outcomes and convenience while lowering costs.

Jul 06 2020

Love0

413th Edition – July 6, 2020

By admin BHI Weekly Newsletter Archives

<!doctype html> BioHealth Innovation

July 6, 2020

FOUNDING MEMBER OF

Prestigious annual pediatric medical device competition reveals 10 finalists including BHI client Innara

WASHINGTON, June 29, 2020 /PRNewswire/ — Ten finalists have been named in the prestigious annual “Make Your Medical Device Pitch for Kids!” competition presented by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). Representing innovations in cardiovascular, orthopaedic and spine, and neonatal intensive care unit (NICU) medical devices, finalists were selected from a field of 30 semi-finalists who competed in March 2020. The ten innovators now have access to a new pediatric accelerator program and will compete for FDA-funded grants of up to $50,000 each in the final virtual pitch event on Oct. 7 as part of the 8th Annual Symposium on Pediatric Device Innovation, co-located with the MedTech Conference, powered by AdvaMed.

BHI Client Gentian awarded up to NOK 8.0 million funding to develop a novel high-throughput COVID-19 antibody test

Gentian Diagnostics AS is pleased to announce that the Research Council of Norway (Norges Forskningsråd) has awarded Gentian up to NOK 8.0 million of funding to support the development of a high-throughput COVID-19 antibody test. Gentian has in cooperation with Professor Ørjan Olsvik and Dr. Vegard Skogen at the University of Tromsø, The Arctic University of Norway performed explorative test work that supports an idea of developing a COVID-19 antibody test based on Gentian’s proprietary technology. The assay, if successfully developed, will be designed for use on clinical analysers already available in major laboratories around the world.

Baltimore biotech company PathSensors will be acquired – Technical.ly Baltimore

Inner Harbor-based biotech company PathSensors will be acquired by global security screening and threat detection company Smiths Detection, the companies announced this week.

With the deal, PathSensors will become part of a London-based company with 2,200 employees and a U.S. headquarters in Edgewood.

Image: PathSensors is headquartered at Columbus Center. (Photo by Wikimedia Commons user Smash the Iron Cage, used under Creative Commons license)

Emergent BioSolutions Signs Five-Year Agreement for Large-Scale Drug Substance Manufacturing for Johnson & Johnson’s Lead COVID-19 Vaccine Candidate | Emergent BioSolutions Inc.

GAITHERSBURG, Md., July 06, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced a five-year manufacturing services agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for large-scale drug substance manufacturing for Johnson & Johnson’s investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant based on the AdVac® technology. Emergent will provide contract development and manufacturing (CDMO) services to produce drug substance at large scale over five years, valued at approximately $480 million for the first two years.

Fueling an Innovation Ecosystem for Startups to Thrive (Bendis to Moderate)

BHI’s own Rich Bendis will Moderate.

Fueling an Innovation Ecosystem for Startups to Thrive

Click here for more information and to register.

Former MedImmune Employees Leading In the BioHealth Capital Region and Beyond · BioBuzz

In a recent conversation someone shared the quote “You can’t throw a stone in the BioHealth Capital Region and not hit somebody who worked at MedImmune”. This statement emphasizes how important the company was in seeding the growth of the biotech industry in Maryland. Founded by Wayne T. Hockmeyer in 1988 as Molecular Vaccines, Inc., MedImmune became one of the cornerstone Biotech companies in what eventually was named the BioHealth Capital Region.

Novavax hires new manufacturing chief to take COVID-19, flu vaccine hopefuls across the finish line | FiercePharma

With its COVID-19 vaccine hopeful cycling through clinical trials, shot maker Novavax is working to flesh out its executive team to help lead the company to the commercial stage. But you can’t get regulatory approval without a sturdy manufacturing operation—and now Novavax has hired an exec to get that operation in order.

Novavax tapped Ben Machielse as its executive vice president of chemistry, manufacturing and controls (CMC) as the vaccine maker works to take its COVID-19 and four-strain flu hopefuls across the finish line, the company said Monday.

Image: Novavax’s newest manufacturing head will join newly hired Chief Medical Officer Filip Dubovsky. (Novavax)

QIAGEN Shareholders Approve All Agenda Items Related to Acquisition by Thermo Fisher Scientific at Annual General Meeting | Business Wire

VENLO, The Netherlands–(BUSINESS WIRE)–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced that its shareholders today approved all agenda items at the Company’s Annual General Meeting related to the proposed voluntary public takeover offer for the acquisition of all ordinary shares in QIAGEN by Quebec B.V., a wholly-owned subsidiary of Thermo Fisher Scientific Inc. (NYSE: TMO) for EUR 39 per share in cash (the “Offer”).

Protaryx Medical Announces $8.3M in Funding for First-in-Class Technology for Left Atrial Access in Transcatheter Cardiac Procedures | Business Wire

BALTIMORE–(BUSINESS WIRE)–Protaryx™ Medical, a company committed to reimagining access to the left atrium for transcatheter cardiac procedures, today announced that it has raised $8.3 million in funding to develop the company’s first-in-class device for precision transseptal access to the left atrium during structural heart and catheter ablation procedures. The company’s funding includes non-dilutive grants and a seed round totaling $3.2 million and the recently closed $5.1M Series A financing led by Ajax Health, with participation from University of Maryland (UM) Ventures, a returning investor.

ITI Enters into License Agreement with Ichor to Use Electroporation (EP) Delivery Technology in Phase I Study of DNA Vaccine Therapy, ITI-1001 – BioHealth Capital Region

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms and Ichor Medical Systems (“Ichor”), a privately held biotech company based in San Diego, CA, announced today that the companies have entered into a license agreement to support the development of ITI’s investigational plasmid DNA vaccine therapy, ITI-1001.

ITI will leverage Ichor’s TriGrid® Electroporation technology to increase cellular uptake of ITI-1001 when administered to patients with newly diagnosed Glioblastoma, or GBM. DNA vaccines delivered by conventional injection have experienced challenges to delivery efficiency, resulting in suboptimal immune responses in clinical trials. Ichor’s TriGrid technology utilizes the application of electrical fields in a target tissue to increase intracellular nucleic acid uptake in the local area, resulting in enhanced gene expression.

Avantor® Expands Life Sciences Innovation Center to Address Bioprocessing Needs in Protein Science, Monoclonal Antibodies (mAbs), Cell and Gene Therapy | BioSpace

RADNOR, Pa., June 30, 2020 /PRNewswire/ — Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences, advanced technologies and applied materials industries, today announced the expansion of the company’s Bridgewater, N.J. (USA) innovation center. Located close to biotech companies, the site now has nearly double the laboratory and support space.

Bioprocessing efficiency that doesn’t compromise quality continues to be a top priority for the biopharma industry. At the same time, it’s critical to meet increasingly stringent global regulatory standards.

Alexandria LaunchLabs – AgTech, the Premier Platform Accelerating the Growth of Early-Stage AgTech and FoodTech Companies, Announces Winner of Its Inaugural $100,000 AgTech Innovation Prize

PASADENA, Calif. and DURHAM, N.C., June 30, 2020 /PRNewswire/ — Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, technology and agtech campuses in AAA innovation cluster locations, today announced the winner of its inaugural $100,000 AgTech Innovation Prize that called on innovators with demonstrated novel approaches to agriculture-, food- and nutrition-related challenges, which are key to advancing human health. The prize was awarded to TerMir Inc., a North Carolina–based agtech company pioneering an innovative and environmentally safe treatment for citrus greening disease—one of the most devastating citrus diseases in the world. Citrus greening disease has resulted in a drop in citrus production and harvesting while driving up costs and job losses. In response to this presently incurable agricultural, environmental and economic challenge, TerMir has developed a cutting-edge and effective solution for breaking the greening cycle with the potential to eradicate the disease.

Innara Health joins MedTech Innovator accelerator – Kansas City Business Journal

Olathe-based Innara Health is setting its sights on international expansion, and its acceptance into a national accelerator program could help that goal come to fruition.

Image: Innara Health’s NTrainer System helps infants born prematurely transition to oral feeding. INNARA HEALTH

Six Veteran-Owned Life Science Companies to Know in the BioHealth Capital Region · BioBuzz

Across Maryland and the BioHealth Capital Region (BHCR), state-level support for veteran-owned and operated life science businesses is strong.

This is evidenced by the rich and diverse tapestry of veteran led life science organizations in the region that spans a number of disciplines, including genomics, regenerative medicine, lab equipment and support, testing and biorisk management services.

Here are BHCR veteran-owned life science companies to keep an eye on as we move deeper into 2020.

Image: https://biobuzz.io

Five BioHealth Capital Region Companies Make List of Largest COVID-19 Government Contracts · BioBuzz

At BioBuzz, we’ve been chronicling the BioHealth Capital Region’s contributions to the battle against the coronavirus pandemic. We’ve covered BHCR companies developing vaccine candidates and creating diagnostic and serological COVID-19; we’ve also written about companies across the region that have delivered essential materials for the fight against COVID-19 and pivoted their business models to help the region navigate this public health crises.

Image: https://biobuzz.io

Mark your calendars now! 5th Annual Women Building Bio (Interactive Virtual Conference)

September 12, 2020

Special Guests Including:

Dr. Michele McMurry-Hearth

President and CEO,

Biotechnology Innovation Organization (BIO)

The Life Sciences Report: Summer 2020 | Wilson Sonsini Goodrich & Rosati – JDSupra

The latest issue of The Life Sciences Report features an interview with Matthew J. Meyer, the firm’s chief client corporate development officer, who has broad management experience in the life sciences sector; a piece authored by Paul Grand and Kathryn Zavala of MedTech Innovator outlining 10 reasons why health care start-ups fail; an interview with Ryan Phelan, co-founder and executive director of Revive & Restore, a 501(c)(3) foundation using 21st century biotechnology to address urgent conservation challenges; and an article by Paul P. Campbell of W. L. Gore & Associates on life sciences innovation culture and deconstruction. In addition, the publication includes articles covering life sciences venture financings in which firm clients participated during 2019, the FDA’s recent issuance of a MAPP on the conversion of ANDA approval to tentative approval, and a sampling of COVID-19-related client activity in which the firm has been involved, as well as a summary of other select recent life sciences client highlights.

Image: https://www.jdsupra.com

Johns Hopkins Medicine CEO: Predictive analytics, precision medicine and AI are the future of medicine

Paul Rothman, MD, CEO of Baltimore-based Johns Hopkins Medicine and dean of the medical faculty at Johns Hopkins University, discussed the health system’s COVID-19 data platform and the potential for artificial intelligence to make a difference in how health systems approach treatment in the future in an interview with The Media Line.

Since the pandemic began, Johns Hopkins has gathered COVID-19 data and reported it on a public dashboard for cases and deaths in the U.S. and across the world. Dr. Rothman said the health system is using artificial intelligence and machine learning in its platform and aims to collaborate with others to incorporate data in the future.

Next in Naturals QuickFire Challenge on Immune-Support – Challenge | JLABS

Families often turn to dietary supplements inspired by nature with ingredients such as Elderberry, Vitamin C, and Zinc with the aim to help safely support their immune systems. A heightened awareness for the need to support your immune system throughout the year has resulted in an increased demand for products with immune-supporting and wholesome ingredients.*

To that end, we’re launching the Next in Naturals QuickFire Challenge on Immune-Support, calling on innovators to submit potential solutions inspired by nature that aim to support healthy immune systems in babies, children, or adults.

The innovator(s) with the best idea(s) will receive up to $50,000 in grant funding, one year of residency at an available JLABS, and the opportunity to engage with leadership from Johnson & Johnson Innovation.

Reopening in an Era of COVID-19 – YouTube

https://www.youtube.com/watch?v=qnR9Cmt7am0

COVID-19 Drug & Vaccine Candidate Tracker | GEN

Welcome to GEN’s COVID-19 DRUG & VACCINE CANDIDATE TRACKER website.

Total Drug & Vaccine Candidates: 237 (as of June 8)

The goal of this resource is to provide a comprehensive collection of news, milestones, and updates on drug and vaccine candidates currently being developed for the COVID-19 pandemic.

This resource is based on the reporting of GEN senior news editor Alex Philippidis, who began compiling information on drug and vaccine candidates in the early weeks of the pandemic. The numbers of verified candidates ballooned rapidly from 35 in February 2020, to 60 in March, to 160 in April.

NYC Builds Bio | The City’s Premier Organization for Real Estate.

Across the country today, not just in Boston and San Francisco, in leading and emerging life science clusters, life sciences institutions and innovative companies are working on cell and gene therapies, corona virus vaccines and drugs, and new bioengineering technologies that have the potential to change the way we feed, fuel and heal the world.

The biotech IPO boom is becoming ‘historic’ as four more throw their hats in – Endpoints News

Four more US biotechs filed to go pub lic Fri day as yet more com pa nies clam ber to get through a yawn ing IPO win dow and on to a mar ket that’s sig naled its will ing ness to re ward near ly any new drug mak er.

The new en trants are led by ALX On col o gy and the bi o log i cal an a lyt ics biotech Berke ley Lights, each of whom filed to raise $100 mil lion. The au toim mune com pa ny Pan dion Ther a peu tics al so filed for $75 mil lion, and Kiromic Bio phar ma, a tiny im muno-on col o gy start up based in San An to nio, filed for $25 mil lion.

Baltimore firm Protaryx making medical devices for heart surgery raises $8M – Baltimore Business Journal

The UMB-born startup was co-founded by cardiac surgery chief Dr. James Gammie, who was previously involved with another company that was acquired in 2017 for up to $250 million.

Emergent Bio inks five-year deal with J&J for manufacture of COVID-19 vaccine (NYSE:EBS) | Seeking Alpha

Emergent BioSolutions (NYSE:EBS) has closed a five-year agreement with Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceuticals for large-scale drug substance manufacturing for J&J’s SARS-CoV-2 vaccine, Ad26.COV2-S.

EBS will provide contract development and manufacturing services over the contract term valued at ~$480M for the first two years. Volume manufacturing will start in 2021 at its Baltimore Bayview facility subsequent to technology transfer.

The company will release updated 2020 guidance when it reports Q2 results.

JNJ is up 2% premarket and EBS up 1%, both on light volume.

Biobuzz Directory – Altimmune Receives Award From U.S. Department of Defense to Fund Phase 1/2 Clinical Trial of T-COVID™ in Outpatients With Early COVID-19

GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced it was awarded $4.7 million from the U.S. Army Medical Research & Development Command (USAMRDC) to fund its Phase 1/2 clinical trial of T-COVID, an investigational intranasal immune modulator for the treatment of outpatients with early COVID-19. The competitive award was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium (MTEC), a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense (DoD). The award is expected to provide Altimmune sufficient funding to cover the entire cost of conducting this clinical trial.

Jun 29 2020

Love0

412th Edition – June 29, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

June 29, 2020

FOUNDING MEMBER OF

Alex Philippidis, Genetic Engineering and Biotechnology News Senior News Editor, Guests on BioTalk

Alex Philippidis joins Rich Bendis on BioTalk to discuss the BioHealth Capital Region from a National viewpoint, other Hubs, and how the industry has adapted in the age of COVID-19.

Alex specializes in biopharma business news and industry issues for GEN. He joined GEN in 2011 after four years at GenomeWeb, where he covered research institutes and spent three years following biotech economic development as editor of the weekly newsletter BioRegion News. Alex reports a variety of news stories for GEN and Clinical OMICs and compiles the popular A-Lists series.

Novavax charges ahead with $200M, David Mott appointed to board – Washington Business Journal

Novavax Inc. plans to advance its Covid-19 vaccine candidate with new additions to the company and about $200 million in new funds from selling convertible preferred stock — the latest cash infusion for the Gaithersburg vaccine maker.

The preferred private placement with a Boston-based RA Capital Management investment fund, in a deal that closed June 16, came fewer than two weeks after Novavax (NASDAQ: NVAX) won a Department of Defense contract worth up to $60 million to help manufacture its coronavirus vaccine candidate. It also builds upon $388 million Novavax landed from the Norway-based Coalition for Epidemic Preparedness Innovations for the same program. And it follows the company’s preparations to sell up to $250 million in common stock, a move that sent its stock soaring toward the end of May.

AsclepiX Therapeutics Announces $35 Million Series A Financing | AsclepiX Therapeutics

BALTIMORE, MD, June 24, 2020 – AsclepiX Therapeutics, Inc., a biopharmaceutical company that uses computational biology to identify potent peptide regulators of vascular homeostasis for the treatment of retinal and other important diseases, today announced that it has closed a $35 million Series A financing led by Perceptive Xontogeny Venture Fund (“PXV Fund”) with participation from the Perceptive Life Sciences Fund, both funds managed by Perceptive Advisors, and existing investors Rapha Capital Management and Barer & Son Capital.

Children’s National, NCC-PDI hold medical device competition for COVID-19 innovations – Today’s Medical Developments

In response to medical data highlighting the serious impact of COVID-19 on children’s health, Children’s National is partnering with the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) on a special pitch competition focused on COVID-19 related pediatric medical devices. “Make your Medical Device Pitch for Kids! – COVID-19 edition” is seeking devices that support home health monitoring and telehealth and improve sustainability, resiliency, and readiness in diagnosing and treating children during a pandemic.

Image: https://www.todaysmedicaldevelopments.com

HemoShear Therapeutics Receives FDA Clearance of IND for Phase 2 Study of its Investigational Drug HST5040 for the Treatment of Methylmalonic Acidemia and Propionic Acidemia

Charlottesville, Va., June 24, 2020 – HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a phase 2 clinical trial of HST5040, an oral small molecule drug for the treatment of patients with methylmalonic acidemia (MMA) and propionic acidemia (PA). MMA and PA are rare genetic disorders caused by the deficiency of certain enzymes required to metabolize amino acids. The diseases result in the rapid buildup of life-threatening metabolites that can lead to severe organ damage, seizures, developmental deficits, and premature death.

Altimmune Receives Award from U.S. Department of Defense to Fund Phase 1/2 Clinical Trial of T-COVID™ in Outpatients with Early COVID-19 | BioSpace

AstraZeneca leading the Covid-19 vaccine race; may get results quite early: WHO – The Hindu BusinessLine

The World Health Organization said on Friday that AstraZeneca’s experimental Covid-19 vaccine is the world’s leading candidate and reached the final stage in terms of development, Reuters reported.

AstraZeneca, a potential vaccine for coronavirus which is being developed by the researchers at the University of Oxford, has entered in large-scale, mid-stage human trials of the vaccine. This week, AstraZeneca signed its tenth supply-and-manufacturing deal.

Image: https://www.thehindubusinessline.com

Replicate Bioscience and Immunomic Therapeutics Form Collaboration to Combat Infectious Diseases and Cancers | Business Wire

ROCKVILLE, Md. & SAN DIEGO–(BUSINESS WIRE)–Replicate Bioscience, Inc. (“Replicate”), a privately-held biopharmaceutical company creating novel treatments to prevent drug resistance in cancers, and Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that the companies have entered into a research and licensing option agreement to combine their platform technologies to combat infectious diseases and cancers.

NIIMBL Announces Nine Project Recipients of $8.9M in Pandemic Response Efforts

NEWARK, Del., June 24, 2020 /PRNewswire/ — Today, the National Institute for Innovation in Manufacturing Biopharmacueticals (NIIMBL) announces that they have identified nine projects to allocate approximately $8.9 million from the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) award received in May 2020 towards the support the nation’s response to the COVID-19 pandemic.

VC fund focused on biotechnology startups spins out of Camden Partners – Baltimore Business Journal

George Petrocheilos and R. Jacob Vogelstein have left Camden Partners to continue to lead the newly independent fund as its managing partners.

Image: George Petrocheilos and R. Jacob Vogelstein are the managing partners of venture investment fund Catalio Capital Management LP. MARK DENNIS

Scientific Engagement Lead JLABS @ Washington, DC in Washington, District of Columbia | Non Operating Companies

Johnson & Johnson Innovation is recruiting a Scientific Engagement Lead of Johnson & Johnson Innovation JLABS. The goal of Johnson & Johnson Innovation is to advance transformative healthcare solutions that improve the lives of people around the world and, in so doing, to deliver value to Johnson & Johnson (“J&J”). JJI accomplishes this by catalyzing new science and technology through collaboration and exchange of ideas. This growing team is looking for a colleague inspired to help build and innovate new ways of fostering a productive life-science ecosystem.

Scott Plank’s newest venture is in the world of organ transplantation – Baltimore Business Journal

Scott Plank’s latest investment is in a company that aims to solve logistical challenges within the organ transplant industry.

MediGO offers a hardware and software platform for organ transplantation logistics, designed to make it easier to track donated organs as they are delivered to their recipients.

Image: https://www.bizjournals.com – JONATHAN MUNSHAM

Summer, is that you?

Dear Innovator,

Happy Pride Month! It’s hard to believe it’s almost July. While we’re facing many challenges here in both Washington, DC and in the U.S., the team and I continued to stay busy while working from home over these past few months.

I wanted to take some time to update you on JLABS @ Washington, DC and our activity. Recently I visited the site and was encouraged to see the progress. The construction team has been hard at work even during these tough times and I am very thankful for those working on the front lines, to include our construction workers, during COVID.

Center for Innovative Technology names this year’s grant recipients – The Virginian-Pilot – Inside Business

A drug company trying to save infants’ lives, a university center protecting hospitals from hackers, a tech company building extreme drones: three groups in the region are getting a cash boost from a fund that spurs innovation in Virginia.

Of the 26 tech companies and four universities receiving grants this year from the Center for Innovative Technology’s Commonwealth Research Commercialization Fund, three are from this region: ReAlta Life Sciences, Old Dominion University and Sentinel Robotic Solutions.

Image: https://www.pilotonline.com

The race to find a COVID-19 vaccine – CBS News

It’s not an understatement to say that the entire nation’s hopes are focused on what’s happening in a Maryland laboratory – step one in manufacturing a potential coronavirus vaccine.

Sean Kirk, executive vice president of Emergent BioSolutions, explained to correspondent Martha Teichner how a bioreactor is used to create the ingredients needed in the development and testing of a vaccine for clinical trials already underway in Australia. “This is where it begins, to produce the hundreds of millions of doses,” he said.

Image: https://www.cbsnews.com

BioHealth Capital Region M&A Roundup First Half of 2020 · BioBuzz

It has been a tumultuous 2020 for venture capital and mergers and acquisitions due to the market uncertainty sparked by the onset of the coronavirus pandemic. Companies seeking acquisitions and venture capital firms alike continue to find their footing, as do the life science companies progressing toward important milestones during a global public health crisis.

Image: https://biobuzz.io

With cell and gene therapy boom coming, experts at Novartis, Kite trumpet need for capacity | FiercePharma

Cell and gene therapy has evolved into one of the biopharma industry’s hottest markets, with a major splash of investment and a run of approvals anticipated in the coming years. To meet what’s likely to be massive demand for manufacturing capacity, industry experts are calling for “forward-looking” investments—but as one pointed out, those checks aren’t easy to write.

Image: As many as 10 to 20 new cell and gene therapies could be approved each year through 2025. (Gilead)

Novavax Expands Executive Leadership and Announces Key Promotions | Novavax Inc. – IR Site

GAITHERSBURG, Md., June 29, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Ben Machielse as Executive Vice President, CMC, with responsibility for overseeing Novavax’ manufacturing, process technology, quality and regulatory functions. The Company also announced several leadership promotions:

Update on New JLABS Incubator in Washington, DC – Blog Post | JLABS

Our newest Johnson & Johnson Innovation JLABS location, JLABS @ Washington, DC, continues to move closer to opening later this year. We recently caught up with Sally Allain, Regional Head of JLABS @ Washington, DC to get the latest updates on construction, how the team has adjusted in response to COVID measures, and what we can expect for the remainder of 2020.

FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials | FDA

The U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analyzed by the FDA during the drug approval process, it is rarely included in product labeling and, therefore, is largely inaccessible to the public.

Image: https://www.linkedin.com/posts/astrazeneca_today-the-fdas-oncology-center-of-excellence-activity-6681307663625728000-S01t/

How telemedicine can help close the maternal health gap | Healthcare IT News

In 2012, there were fewer than 1,400 maternal-fetal medicine specialists in the United States, and 98% resided inmetropolitan areas.

This left pregnant patients in rural areas without the ability to access care, especially if travel was not an option.

Today, telehealth can be used to fill that gap – but providers still may face challenges in ensuring patients get the services they need.

Virtual PitchRounds – BioPharma and MedTech Innovation

Southeast Life Sciences, the organization behind 400 presentations, 790 funding transactions, and $5.2B in investments from 500 distinct investors is going virtual for a special edition of PitchRounds.

SE PitchRounds is Southeast Life Sciences presentation program. This special PitchRounds event is intended for companies in the southeast United States that are working on products, services, etc. that are addressing a need related to Covid-19. If you have any questions about eligibility, please contact Jason Rupp at jrupp@southeastlifesciences.org

MedTech Innovator Announces Top 50 Medtech Startups Selected for Annual Showcase and Accelerator | Business Wire

LOS ANGELES–(BUSINESS WIRE)–MedTech Innovator, the premier nonprofit accelerator in the medical technology industry, today announced the 50 companies selected to participate in the organization’s flagship four-month Showcase and Accelerator program, featuring the industry’s most transformative device, diagnostic, and digital health technologies from around the globe. These up and coming startups will receive unparalleled visibility and access to leading manufacturers, providers, investors, and other industry stakeholders. As part of its Accelerator program, MedTech Innovator will award up to $500,000 in cash and in-kind prizes during its final competition at The MedTech Conference, powered by AdvaMed.

Apr 27 2020

Love0

403rdEdition – April 28, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

April 28, 2020

FOUNDING MEMBER OF

Innara Health and BHI Partner to Accelerate Company Growth

FDA Cleared Medical Device Improves Feeding Outcomes of Infants Born Prematurely

Olathe, KS and Rockville, MD, April 28, 2020—Innara Health, developer of the only FDA cleared medical device designed to improve the feeding outcomes of infants born prematurely, is partnering with BioHealth Innovation (BHI) to support the company’s plans for growth through greater market access and the development of NextGen technology. Innara Health is dedicated to improving feeding outcomes for newborn and infants born prematurely. “As we continue to expand our domestic footprint, we are very fortunate to call BHI our partner as their infrastructure and access will certainly support Innara in our journey to redesign the NTrainer, enter into adjacent markets, and expand globally” states Innara CEO Chris Mathia. “We are excited to support Chris and his team as they expand, grow and develop new technology ultimately enabling many more NICU patients to return home to their families sooner and healthier” said BHI CEO Rich Bendis.

Immunomic Therapeutics Announces Close of $61.3M Financing – Bloomberg

Immunomic Therapeutics, Inc., (“ITI”) a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today the close of a $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs. This represents the second closing in the investment process for the HLB Consortium, ($10M was placed in February 2020), and substantially increases their holding in Immunomic Therapeutics to 47.6% of the common stock. HLB also secured an option to make further investment into the company in the months ahead.

Gentian AS Seeking Collaborator to Test BioMarker Performance in Severe COVID-19 Cases

Gentian AS, a Norwegian company, with its US office at BioHealth Innovation in Rockville, Maryland is seeking collaborators to investigate if two of the biomarkers in their portfolio, cystatin C (FDA510(k) cleared) and plasma calprotectin (US research only), could potentially be useful for detection of the severely affected COVID-19 patients.

High mortality and long hospitalization are consequences of the severe cases with COVID-19 pneumonia. Gentian therefore believes that it is important to identify biomarkers that can aid in early, rapid and effective identification of the severely affected patients.

LifeSprout, Inc. Closes $28.5 Million Series A Financing

BALTIMORE, Md., April 27, 2020 /PRNewswire/ — LifeSprout, a privately-held regenerative medicine company founded with technology licensed from Johns Hopkins University, has closed a $28.5 million Series A financing. The company is using proceeds to support clinical development of novel therapeutic products from its Regenerative Matrix platform.

The financing was led by Redmile Group, LLC, with new institutional investors Nexus Management, LP, Emerald Development Managers, LP, and the Abell Foundation joining the syndicate.

“We are delighted to complement the lead investment from Redmile with a strong cadre of Maryland-based and international investors,” stated Sashank Reddy, MD, PhD, co-founder of LifeSprout. “The early, visionary investments made by the Maryland Stem Cell Research Fund and others made this new financing possible.”

Baltimore Company Will Produce COVID-19 Vaccine Under New Agreement With Johnson & Johnson | WBFF

A Baltimore company will be at the forefront of producing a potential coronavirus vaccine.

Once a COVID-19 vaccine is ready for mass production, the company is going to be making hundreds of millions of them.

“We’ll be providing the drug substance manufacturing which is essentially the vaccine itself,” says Syed Husain, senior vice president of Emergent BioSolutions.

All of that work will happen at Emergent BioSolutions, which is located in front of Johns Hopkins Bayview.

Personal Genome Diagnostics Receives FDA Clearance for PGDx elio™ tissue complete, the First Comprehensive Genomic Profiling Diagnostic Kit for Oncology | Business Wire

BALTIMORE–(BUSINESS WIRE)–Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio™ tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner. By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

REGENXBIO Announces Additional Positive Long-term and Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD | REGENXBIO Inc.

REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today provided additional long-term data from the ongoing Phase I/IIa trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).

“I am impressed by the overall outcomes in patients after a one-time administration of RGX-314. I believe that RGX-314 is the leading gene therapy program for a major retinal disease such as wet AMD and could be an important potential one-time treatment option for AMD patients who require frequent and burdensome anti-VEGF injections. Real-world evidence demonstrates that patients lose vision over time with our current standard of care and incur significant treatment burden with frequent clinic visits and injections,” said Allen C. Ho, M.D., Director of Retina Research at Wills Eye Hospital and Mid Atlantic Retina and investigator surgeon in the RGX-314 trial.

Hard to Find Small Lab Space – Only Two Spaces Left! – Alexandria LaunchLabs™

Governor Hogan Introduces Safe, Gradual, and Effective ‘Maryland Strong: Roadmap to Recovery’

ANNAPOLIS, MD—After weeks of consulting with leading scientists, business leaders, and public health experts, Governor Larry Hogan today introduced the ‘Maryland Strong: Roadmap to Recovery,’ which provides a safe, effective, and gradual approach to reopening the state as it continues to combat the COVID-19 pandemic.

“As we begin to reopen, it will continue to be important for Marylanders, particularly older and more vulnerable Marylanders, to continue to stay home as much as they can,” said Governor Hogan. “All Marylanders should continue to avoid crowds and gatherings, and they should continue to practice physical distancing and to take precautions to protect themselves, their families, and their fellow Marylanders. Together, we are going to defeat this virus, and together, the State of Maryland will return stronger and better than ever.”

Image: https://governor.maryland.gov

Five takeaways from Gov. Larry Hogan’s plan to reopen Maryland – Baltimore Sun

Maryland Gov. Larry Hogan on Friday announced his three-phase plan to eventually reopen the state amid the coronavirus pandemic.

Hogan called the plan a “well-thought-out, gradual, safe and effective path forward,” supported by four pillars he has spoken about often in recent weeks: increases in testing, personal protective equipment, contact tracing and hospital surge capacity.

Emergex Signs Agreement with GEORGE MASON UNIVERSITY for Highly Pathogenic RNA Virus Studies

Emergex Vaccines Holding Limited (‘Emergex’), a biotechnology company developing CD8+ priming set-point vaccines to prevent serious infectious diseases, today announced that it has entered into an agreement with the George Mason University, based in Virginia, in the United States.

The agreement specifies that George Mason University’s National Center for Biodefense and Infectious Diseases will provide their unique expertise and resources as a partner in the development of Emergex’s vaccines against highly pathogenic RNA viruses. In particular, George Mason University’s Biosafety 3 capabilities, coupled with their experience in dealing with RNA viruses, means that they are a well-suited collaborator on the vaccine validation studies, as well as the optimization of vaccine design.

AGT CEO Jeff Galvin on the Future of the Gene and Cell Therapy Industry | BioSpace

The rapid growth of biopharma is causing a shift to a new paradigm for the drug development and delivery model. In the same manner that the personal computing industry grew and developed business models that fit the way products were sourced, constructed and delivered, a business model for biopharma is taking shape.

Image: https://www.biospace.com

J&J to partner with Emergent Bio on coronavirus vaccine candidate (NYSE:JNJ) | Seeking Alpha

Johnson & Johnson (NYSE:JNJ) says it will work with Emergent BioSolutions (NYSE:EBS) to produce more than a billion doses of a COVID-19 vaccine candidate, as it seeks to scale up global manufacturing of its potential treatment.

J&J says it is already preparing for clinical vaccine production at its Leiden facility in the Netherlands, with the aim of starting its Phase 1 clinical trial of its vaccine candidate on humans in September and potentially having it ready under an emergency use authorization next year.

What Is Contact Tracing? How It Will Be Used for COVID-19 | Time

In the coronavirus era, a host of epidemiological terms have entered common public use. There’s the now-ubiquitous “social distancing,” and the newly politicized “flatten the curve.” And as states and local governments seek a way out of lockdowns that have brought their economies to a near-standstill, “contact tracing” has made its way into everyday conversation as well.

Image: Public health nurse Lee Cherie Booth conducts a test for COVID-19 outside of the Salt Lake City Public Health Center on April 10, 2020, accompanied by Salt Lake County infectious disease nurse Travis Langston. When a swab test comes back positive, contact tracing starts. Scott G Winterton—The Deseret News via AP

JLABS @ Washington, DC Children’s QuickFire Challenge

When a child gets seriously sick, it’s up to us to fight for the world that they believe in. Johnson & Johnson Innovation is at the forefront of that fight. Helping to build a better future for the next child battling cancer, fighting the flu or facing the need for surgery.

The JLABS @ Washington, DC Children’s QuickFire Challenge invites innovators to submit game changing ideas, technologies, and solutions that have the potential to impact pediatric oncology, pediatric surgery and influenza. The innovator(s) with the best idea(s) will be awarded up to $150,000 in total grant funding; one year of residency at JLABS @ Washington, DC with the use of a bench, workstation, and access to the JLABS @ Washington, DC community; and mentorship from experts at the Johnson & Johnson Family of Companies

Maryland’s venture capital funding was on the rise in Q1 2020. Then the pandemic arrived – Technical.ly Baltimore

Maryland tech companies started the year bringing in a surge of venture capital funding, and three of the state’s top 10 deals were in Baltimore, according to data from the latest PwC/CB Insights MoneyTree report. But a downturn in the last two weeks as the COVID-19 pandemic-caused slowdown took hold is leaving reason to keep celebrations on lockdown for now.

The $227 million that 21 companies raised from investors was a 44% uptick from the $115 million in the fourth quarter of 2019.

Image: The Huntress team. (Courtesy photo)

What to do after receiving a Paycheck Protection Program loan – Philadelphia Business Journal

Just over three weeks ago the CARES Act, a massive piece of legislation designed to combat the economic havoc being wrought by the coronavirus pandemic, was enacted.

One significant piece of that legislation is the Paycheck Protection Program (PPP), which allows small businesses to borrow funds from the Small Business Administration and affiliated lenders roughly equivalent to 2.5 months of payroll costs. The use of borrowed funds is restricted to “payroll costs” (employee compensation, group health benefits, retirement benefits, state unemployment taxes), rent, mortgage interest, interest on other loans and utilities.

Across the country, children’s hospitals are grappling with significant financial impacts due to the COVID-19 crisis.

Across the country, children’s hospitals are grappling with significant financial impacts due to the COVID-19 crisis. We are dealing with substantial decreases in revenue as well as increased expenses directly tied to addressing this global pandemic. Children’s National Hospital is losing $1 million a day. I had a chance to share our challenges with NBC News Reporter Josh Lederman and to spotlight some potential solutions. #covid19 #pediatrics #finances #federalfunding #healthcare #childrenshospital

This physician-founder is making a device to protect medical staff during intubation procedures – Technical.ly Baltimore

Working as an emergency and critical care physician at the University of Maryland School of Medicine, Dr. Steven Tropello is seeing the lack of protective equipment for medical workers up close.

One particular area is during a procedure in which a tube is inserted into a patient’s airway, called intubation. It’s necessary to place someone on a ventilator, but presents danger of spreading the new coronavirus through the air or touch to doctors if they lack protection.

Image: CareCove. (Courtesy photo)

How to reopen the US, according to Johns Hopkins and Harvard – Business Insider

Most Americans are still stuck at home, but a trio of reports, out from Harvard, Johns Hopkins, and former US Food and Drug Administration Commissioner Scott Gottlieb, are starting to lay a foundation for what reopening the country might look like, if done safely.

Though staying inside is certainly keeping more infections at bay right now, it’s not without its costs.

Aside from the strain stay-at-home orders are putting on families, friends and communities, the newfound national quiet means the US is “hemorrhaging $100 billion to $350 billion a month,” according to the new Harvard analysis, which was released on Monday.

Image: A worker wears a protective face mask in a factory of roll-forming machine maker Gasparini, in Mirano. Reuters

Dr. Anthony Fauci ‘Not Overly Confident’ With US COVID-19 Testing | TIME

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and member of the White House Coronavirus Task Force, says “we are not in a situation where we can say we are exactly where we want to be with regard to testing” capacity for COVID-19 in the U.S.

Fauci, in a discussion for TIME 100 Talks: Finding Hope on Thursday, says that the U.S. needs to not only increase the number of tests, which is happening as commercial testing companies increase production and the Food and Drug Administration continues to clear tests using different types of samples (including ones from the nose and saliva, as well as blood). But, he says, we also needs to make sure tests can actually be run the way they should.

5 trends in venture capital (beyond the pandemic) | MIT Sloan

Even prior to COVID-19, change was afoot in the venture capital industry. Machine learning and algorithms were emerging as new ways to spot winners, and cities like Boston staked out turf as VC hot spots, proving that not all innovation takes place in Silicon Valley.

Performance of calprotectin and cystatin C in prediction of severe events in COVID-19 patients

We at Gentian AS believe it is the duty of all companies in the health industry to help combat the ongoing pandemic of COVID-19/Corona virus. High mortality and long hospitalisation are the consequences of the severe cases with COVID-19 pneumonia. Hence, it is important to identify biomarkers that early could aid in rapid and effective identification of the severely affected patients. In the Gentian test portfolio, the two biomarkers, cystatin C and plasma calprotectin, could be useful for the early detection of the severely affected COVID-19 patients. To do our part we are reaching out to research/hospital institutions who want to run a trial to assess whether these biomarkers can make a contribution in the detection of severe COVID-19 cases.

Colleges make plans for bringing students back 2020 – The Washington Post

In a different year, incoming freshmen would already have in hand a tightly choreographed schedule for late summer and early fall: the move-in date, the orientation and, finally, the first day of classes.

But on the coronavirus pandemic calendar, there are no dates yet for the next academic year. Just scenarios. And that unprecedented uncertainty is fueling a second wave of crisis for schools already plunged into financial distress.

Xconomy: Life Science a VC Bright Spot in Q1, But Startups May Soon Struggle

Even as the novel coronavirus has derailed daily life and business operations, the life sciences sector continues to see companies make public debuts and ink both financing and partnership deals.

In venture capital, US deal activity in the first quarter tallied 2,300 financings totaling $34.2 billion, according to the latest report by the National Venture Capital Association, which uses data from PitchBook. That’s roughly on track to match the total raised in the past two years, both record-setters in one way or another. But the likelihood of that pace continuing is slim, according to the report.

Image: Sarah de Crescenzo

Apr 27 2020

Love0

409th Edition – June 9, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

June 9, 2020

FOUNDING MEMBER OF

Anthony D. Saleh, Ph.D., CEO of miRecule, joins Rich Bendis on BioTalk

miRecule CEO Anthony D. Saleh, Ph.D. guests on BioTalk to discuss his company, his many roles in startup companies, and being an Entrepreneur in Residence with BHI

BioHealth Innovation Leading Five Digital RESI Conference Virtual Panels

With the LSN Digital RESI Conference approaching quickly, Event Gold Sponsor, BioHealth Innovation (BHI), is stepping up to help lead five panels with some heavy hitters from the BioHealth Capital Region (BHCR) on June 8-10, 2020.

Great Investment Opportunities in the BioHealth Capital Region

While we adjust to a COVID-19 world, there continue to be great investment opportunities in the BioHealth Capital Region. Join BHCR CEOs as they make short introductions about themselves and companies. Join CEOs from American Gene Technologies International Inc., miRecule, Adaptive Phage, Healion Bio, KaloCyte, Emocha, Tailored Therapeutics, Inc., DEKA, and Ashvattha Therapeutics, Inc.

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your complimentary virtual feedback session with BHI Entrepreneurs-in-Residence and Analysts on one of the following dates: 6/24, 7/22, 8/26. (45 minute blocks of time beginning at 9:00 in the morning. Pre-registration is required; sign up www.tinyurl.com/EIRFeedback. For questions/more information, contact BHI

Emergent BioSolutions will produce COVID-19 vaccines in Baltimore, Rockville under $628 million federal contract – Baltimore Sun

Emergent BioSolutions Inc. will help produce COVID-19 vaccines in Baltimore and Rockville under a federal contract.

Gaithersburg-based Emergent said Tuesday it will manufacture vaccines under an existing contract with a division of U.S. Department of Health & Human Services, assisting government efforts to fast-track the vaccine. Emergent has long worked with the federal health agency’s Biomedical Advanced Research and Development Authority.

Novavax awarded $60M Department of Defense contract for Covid-19 vaccine – Washington Business Journal

Novavax Inc. just scored even more support for its coronavirus vaccine program.

The Gaithersburg company said late Thursday it won a Department of Defense contract worth up to $60 million to help manufacture its Covid-19 vaccine candidate, NVX‑CoV2373. The funding, from the Defense Health Program, would back the production of multiple pieces of the vaccine, to be manufactured in the U.S., according to Novavax’s (NASDAQ: NVAX) announcement.

Virginia Based AMPEL BioSolutions’ Technology Predicts Severity of Illness in COVID19 Patients and Identifies Treatments

Charlottesville, Virginia. June 9, 2020. AMPEL BioSolutions announces genomic analysis and findings that could improve treatment of COVID19 patients with approved drugs such as Embrel and Stelara. Published on bioRxiv as a preprint, the study reveals a gene-based test that will be able to determine those patients who may progress to severe illness with increased likelihood of morbidity. In addition, AMPEL’s CovGENE approach identifies FDA-approved drugs that may be appropriately repositioned to interfere with mechanisms that cause lung damage in severe COVID19 patients. The paper describes gene expression measured in three body compartments (lung, airway and blood) and integrates information from the blood and lung for a “whole body” understanding of the effects of SARS-CoV2 virus.

AstraZeneca lays out plans to produce 2 billion doses of Covid-19 vaccine

The drug giant AstraZeneca said Thursday that it has found partners to manufacture and distribute 2 billion doses of the experimental Covid-19 vaccine created by Oxford University, inking a series of deals with non-government organizations and another manufacturer.

Image: RAPHAEL LAFARGUE/ABACA/SIPA USA VIA AP

AstraZeneca Approaches Gilead About Potential Merger

AstraZeneca Plc has made a preliminary approach to rival drugmaker Gilead Sciences Inc. about a potential merger, according to people familiar with the matter, in what would be the biggest health-care deal on record.

The U.K.-based firm informally contacted Gilead last month to gauge its interest in a possible tie-up, the people said, asking not to be identified because the details are private. AstraZeneca didn’t specify terms for any transaction, they said. While Gilead has discussed the idea with advisers, no decisions have been made on how to proceed and the companies aren’t in formal talks, the people added.

Image: Photographer: David Paul Morris/Bloomberg

Altimmune Launches Clinical Trial for COVID-19 Vaccine for the Treatment of Patients with Early SARS-CoV-2 infection – Biobuzz Directory

GAITHERSBURG, MD, June 1, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with a clinical trial of T-COVID, an investigational agent for the treatment of early COVID-19. Patient enrollment in the Phase 1/2 clinical trial is expected to commence in June, with data readout anticipated in Q4 2020.

T-COVID is based on the same replication-deficient adenovirus 5 (RD-Ad5) vector technology behind Altimmune’s intranasal vaccine candidates, which include NasoVAX for influenza, NasoShield for anthrax, and AdCOVID for COVID-19, but it acts through a different mechanism. In preclinical studies sponsored by the National Institute of Allergy and Infectious Diseases, intranasal administration of RD-Ad5 vectors modulated the innate immune response to lethal challenge with a respiratory virus in mice and protected them from death. The immunomodulatory effects resulted in significantly decreased cellular inflammation and lower concentrations of IL-6 and other inflammatory cytokines in the lungs of treated animals compared to controls.

COVID-19 Vaccine Progress from 14 BioHealth Capital Region Organizations – BioHealth Capital Region – BioBuzz

Editor’s Note: This post was originally published on April 7, 2020. As updates are discovered and advancements are announced regarding the work below, details will be published for accuracy.

As the U.S. continues to find its way through a tough fight against this global pandemic, a number of BioHealth Capital Region (BHCR) biotech companies are making significant contributions to stem the COVID-19 pandemic. With people across the U.S. and the world making sacrifices to flatten the curve — along with nurses, doctors and first responders who stand heroically at the front lines — life science companies in our region are doing everything in their power to make COVID-19 vaccine progress with celerity, safety and efficacy top-of-mind.

U.S. gives AstraZeneca $1 billion for COVID-19 vaccine candidate – UPI.com

May 21 (UPI) — European pharmaceutical company AstraZeneca said Thursday it has received more than $1 billion from the U.S. government to develop its coronavirus vaccine candidate.

The drugmaker has partnered with the University of Oxford on its “AZD1222” vaccine, one of several candidates worldwide in clinical trials.

The funding came from the the Biomedical Advanced Research and Development Authority, a branch of the Department of Health and Human Services.

Image: AstraZeneca plans at least 400 million doses and has lined up manufacturing capacity for one billion doses with first deliveries set for September. File Photo by Drago Prvulovic/EPA

AstraZeneca Ranked Most Inventive, Roche Most Innovative

AstraZeneca (AZN) was ranked the most the most inventive pharmaceutical company for the second year in a row by IDEA Pharma’s Invention and Innovation Index for 2020. Meanwhile, Roche (RHHBY) jumped seven places from its 2019 ranking to capture the top spot in the list of most innovative pharma firms.

IDEA is an international consulting firm that works with pharma companies to position their products in the early phase to maximize market success and consult on innovation. The firm bases its Innovation Index on the answer to the following question: “If two companies had the same molecule, who would be more successful with it?” It also considers their ability to bring products from phases 1 and 2 to market and commercialize them successfully, according to CEO Mike Rea.

CEOs, Academics Step Out to Fill National Leadership Void – Maryland Matters

Amid a wrenching series of crises that have riven the nation, particularly over matters of race and law enforcement, corporate leaders throughout Maryland have voiced support for the social justice movement that has become more urgent and grown after the death of George Floyd.

Over the last few days, corporate CEO’s, university leaders and others have acknowledged the pain that Americans of all stripes are experiencing, and have pledged to be part of the solution.

NodThera Announces Close of $55 Million Series B Financing

Financing round led by Novo Ventures and includes new investors Cowen Healthcare Investments and Sanofi Ventures, as well as existing investors 5AM Ventures, F-Prime Capital, Sofinnova Partners and founding investor Epidarex Capital

Proceeds to support advancement of pipeline of small molecule NLRP3 inflammasome inhibitors, including continued progression of NT-0167 through clinical development

CAMBRIDGE, UK, BOSTON & SEATTLE – June 3, 2020 – NodThera, a clinical stage biotechnology company developing a new class of medicines that inhibit the NLRP3 inflammasome to treat diseases driven by chronic inflammation, today announced that it has secured $55 million (£44 million) in a Series B financing. NodThera’s lead candidate, NT-0167, is being evaluated in a Phase 1 clinical trial in healthy volunteers.

Pfizer Establishes New Program to Support Continued Biotechnology Innovation | Business | oleantimesherald.com

Pfizer Inc. (NYSE: PFE) today announced the establishment of the Pfizer Breakthrough Growth Initiative, through which Pfizer will invest up to $500 million in biotechnology companies to help provide funding and access to Pfizer’s scientific expertise to ensure continuity of the biotechnology companies’ most promising clinical development programs.

“There has never been a more important moment to pursue new collaborations in our industry,” said John Young, Pfizer’s Chief Business Officer. “The Pfizer Breakthrough Growth Initiative seeks to do just this by injecting crucial capital into biotechnology companies that share our commitment to delivering transformative therapies for patients.”

Global Deaths Due to Various Causes and COVID-19

Always good to see a new relational perspective. #perspective #thinking #reflection #designthinking #innovationculture

VCs Cautious of “COVID-19 Contortionists” and Telemedicine “Gold Rush” · BioBuzz

COVID-19 is fundamentally changing how we live, how we do business, and how we approach and deliver our healthcare. In the past 14 weeks, there has been unprecedented growth for a segment of companies who were positioned to meet these rapidly sweeping changes to our lives, while so many others have had to close their doors or are fighting to stay in business. COVID-19 has sparked millions of job losses.

Image: https://biobuzz.io

SARS-CoV-2 Infection Mapped through Respiratory Tract

SARS-CoV-2 is known to infect cells of the respiratory tract. A deeper understanding of which cells support the infection, and to what extent, could lead to insights into disease progression and severity. Scientists at the UNC School of Medicine sought to understand which cells in the airway the virus infects, and how it gets into the lungs in the patients who develop pneumonia. To this end, they have characterized some of the ways in which SARS-CoV-2 infects the nasal cavity and infects and replicates progressively less well in cells lower down the respiratory tract—including the lungs.

Image: SARS-CoV-2 (red) infected ciliated cells in the COVID-19 patient’s bronchi. (Takanori Asakura, PhD, UNC School of Medicine)

Novavax Awarded Department of Defense Contract for COVID-19 Vaccine Nasdaq:NVAX

GAITHERSBURG, Md., June 04, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the company has been awarded a contract by the U.S. Department of Defense (DoD) for the manufacturing of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant.

Apr 27 2020

Love0

410th Edition – June 16, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

June 16, 2020

FOUNDING MEMBER OF

Fina Biosolutions Receives SBIR Matching Grant from Montgomery County, MD

Fina Biosolutions recently received a $25,000 Montgomery County SBIR/STTR Phase I matching grant to support its NIH SBIR grant focused on “Genetically detoxified tetanus toxin for use in vaccines.” The grant comes from a subprogram of the Montgomery County Economic Development Fund. Andrew Lees, Fina Biosolutions’ Scientific Director said, “we are very grateful for the County’s support for our research. We intend to use the funds to hire a part-time employee who we expect will transition to full-time. We also are appreciative of the assistance we received from BioHealth Innovation in guiding us through the County grant process”. Fina Biosolutions is developing the genetically detoxified tetanus toxin as a carrier protein for peptide and glycan conjugate vaccines. Montgomery County, Maryland is the first county in the U.S. to offer matching grants to NIH SBIR/STTR awardees to further leverage the public and private investment in their R&D and job growth activities.

Viela Bio Announces U.S. FDA Approval of UPLIZNA™ (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) Nasdaq:VIE

GAITHERSBURG, Md., June 11, 2020 (GLOBE NEWSWIRE) — Viela Bio (Nasdaq:VIE) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. Approximately 80%1 of all patients with NMOSD test positive for anti-AQP4 antibodies.

Glyscend Therapeutics Completes $20.5M Financing Round to Advance Novel Oral Polymer Therapy for Type 2 Diabetes

BALTIMORE, June 11, 2020 (GLOBE NEWSWIRE) — Glyscend Therapeutics, a privately held biopharmaceutical company developing novel treatments for type 2 diabetes (T2D) and related metabolic conditions, today announced the closing of a $20.5 million Series A financing round. Healthcare investors Brandon Capital Partners, through its Medical Research Commercialisation Fund (MRCF), and Santé Ventures led the round of funding, which will be used to support the development of the company’s novel oral polymer therapy for patients with T2D and other metabolic diseases. Breakout Labs (a fund in the Thiel Foundation) provided seed funding in 2019.

AstraZeneca taps Emergent as U.S. partner for potential COVID-19 vaccine – Reuters

AstraZeneca has inked manufacturing deals globally to meet its target of making 2 billion doses of the vaccine, including with two Bill Gates-backed ventures and a $1.2 billion agreement with the U.S. government.

The company’s vaccine is among the first to move into mid-stage trials and the first indication of its effectiveness would likely be available in June or July. There are no approved vaccines or treatments for COVID-19, the highly contagious respiratory illness caused by the novel coronavirus.

2020 AURP BIO HEALTH CAUCUS – Supporting the Growth of Bio Health Innovation Districts Worldwide – RECAP

At AURP’s BIO Health Caucus, we explored trends in life science research, opportunity zone funding resources, the marriage of life science and philanthropy in global partnership opportunities. Discover the unique roles that biomedical innovation cluster and research parks play in innovation ecosystems around the globe. Translating discoveries from the lab to the market has never been more important.

Click here to download the PDF

KaloCyte raises $300K from Maryland Momentum Fund – Technical.ly Baltimore

Less than a year after relocating its headquarters to Baltimore, biotech company KaloCyte has raised new funding from Maryland-based investors and expanded its local team.

On Monday, the company announced that it raised $300,000 from the Maryland Momentum Fund, which is a venture fund created by the University System of Maryland that invests in affiliated companies. It is part of a larger funding round for the preclinical-stage company, which is developing an artificial red blood cell substitute. Called ErythroMer, it can be used in situations where stored red blood cells are not available, such as treating trauma when patients have a need for blood.

Image: Baltimore’s BioPark is part of the University System of Maryland. (Courtesy photo)

Sirnaomics to spin off RNAimmune to develop novel mRNA therapeutics and vaccines – Maryland Daily Record

Sirnaomics Inc., a Gaithersburg-based biopharmaceutical company engaged in the discovery and development of RNAi therapeutics, Friday announced a corporate technology spinoff establishing an independent biopharmaceutical company, RNAimmune Inc. This new entity is focusing on and specializing in messenger RNA (mRNA) based therapeutics and vaccine development, with exclusively licensed Polypeptide-Lipid Nanoparticle (PLNP) delivery technology and large scale …

BRIEF-Novo Nordisk To Acquire Corvidia Therapeutics – Reuters – congrats to Ram Aiyar former BHI EIR

* NOVO NORDISK TO ACQUIRE CORVIDIA THERAPEUTICS AND EXPAND PRESENCE IN CARDIOVASCULAR DISEASE

* UNDER TERMS OF AGREEMENT, NOVO NORDISK WILL ACQUIRE ALL OUTSTANDING SHARES OF CORVIDIA THERAPEUTICS FOR AN UPFRONT PAYMENT OF 725 MILLION US DOLLARS IN CASH

Emmes Announces Its Work on a Phase 3 Clinical Trial for Breakthrough Therapy Designation Product | BioSpace

ROCKVILLE, Md., June 15, 2020 /PRNewswire/ — Emmes Group today announced that it provided the Phase 3 clinical trial support for a new investigational cell therapy that offers a promising treatment opportunity for patients who need an allogeneic bone marrow transplant. Emmes’ work for Gamida Cell Ltd., an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, involved full scope clinical trial support for this study that was conducted at more than 50 centers in the United States, Latin America, Europe and Asia. Emmes also supported the early development Phase 1 and 2 trials that began in 2010.

Charlottesville company develops test to predict most severe cases of COVID-19

CHARLOTTESVILLE, Va. (WVIR) – The COVID-19 pandemic has presented many complex challenges to those in the medical field. One Charlottesville-based company stepped up to the plate to come up with a solution beyond just testing for the virus.

AMPEL BioSolutions typically does personalized medicine for Lupus patients, but when the pandemic struck scientists switched gears: They went beyond just developing a “positive or negative” coronavirus test. Scientists with AMPEL say they have developed technology to predict whether a patient will have mild or severe symptoms, which could be life-saving.

Image: (FILE) (Source: MGN Image) – https://www.nbc29.com

2020 Life Science Venture Capital Funding Roundup for Q1/Q2 in the BioHealth Capital Region · BioBuzz

This has certainly been a year unlike any other for BioHealth Capital Region (BHCR) life science companies of all sizes and kinds. Just a few months into 2020, the coronavirus pandemic swept the region, seriously disrupting, albeit temporarily, the best laid plans of aspiring founders, entrepreneurs, emerging startups, pre-clinical and more established, larger biohealth organizations in Virginia, Washington, D.C. and Maryland.

FSIF COVID BIOSCIENCE APPLIES FOR PATENT ON INNOVATIVE NEW COVID-19 TEST

<p>Cambridge, MD, June 15 — FSIF COVID BioScience, a biotechnology company focused on harnessing the power of the human immune system to diagnosis and treat Covid-19, announced today that it just filed a new patent for the Company’s innovative FSIF(FullSpectrumInterferonFingerprint)COVID-19test. While thetechnology behind thisnewly filed patent will serve as an accurate diagnostic for COVID-19, its real value is the ability stratify patients into degrees of disease severity as noted in the grid below:

Maryland Stem Cell Research Commission Announces over $7 Million in awards to Accelerate Cures | MSCRF

COLUMBIA, Md. (June 5, 2020)— The Maryland Stem Cell Research Commission (Commission) has approved funding to its second round of 2020 recipients for a total of $ 7,053,759. The Commission has also issued a Request for Applications (RFAs) for its first round of funding for fiscal year 2021 and is looking to continue accelerating cutting-edge research and cures through the Maryland Stem Cell Research Fund (MSCRF).

PathSensors Inc. Announced the Completion of Phase I of a SBIR

PathSensors Inc., a Baltimore biotechnology company, announced today the completion of Phase I of a Small Business Innovation Research (SBIR) program funded by the National Institute of Food and Agriculture (NIFA) entitled “Food Safety in the 21st Century: Rapid Toxin Detection in the Field”. The project’s goal was to engineer and develop a field-deployable instrument for portable pathogen and toxin detection.

SilcsBio and Dalriada Drug Discovery Launch Partnership to Create a Rapid Drug Discovery Service Suite | Press Release | I95 Business

June 11, 2020, Baltimore, MD and Toronto, ON – SilcsBio, a technology company that develops innovative software and provides services for structure-based drug design, and Dalriada Drug Discovery, a full service small molecule drug discovery contract research organization supporting global innovators through its TURN-KEY™ model, today announced the launch of a formal partnership to enable enhanced support for their clients’ programs.

Under the new partnership, SilcsBio’s expertise in computer-aided drug design (CADD) will be vertically integrated with Dalriada’s world-class wet-lab drug discovery capabilities accelerating clients’ target-directed programs. Through close work between the two expert scientific teams and integration of CADD, medicinal chemistry, target screening, and ADME, clients can expect accelerated hit identification, lead generation, and lead optimization cycles.

Immunomic Therapeutics to Present at AACR Virtual Annual Meeting II – Immunomic Therapeutics

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc. will present preclinical data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses when used with its investigational UNITE vaccine, ITI-3000, in mice. UNITE fuses a tumor-associated antigen, here a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV), with lysosomal-associated membrane protein 1 (LAMP1). This lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response, as ITI-3000 activated antigen-specific CD4+ T cells in vivo. The data will be presented at the AACR Virtual Annual Meeting II, June 22-24, 2020.

FDA Grant and Gift from Entrepreneur Provide $250K in Awards for Pediatric Medical Device Competition Focused on COVID-19 Innovations | Benzinga

WASHINGTON, June 11, 2020 /PRNewswire/ — As medical data increasingly highlights the serious impact of COVID-19 on children’s health, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces a special pitch competition focused on COVID-19-related pediatric medical devices that support home health monitoring and telehealth, and improve sustainability, resiliency and readiness in diagnosing and treating children during a pandemic.

The Top Biotech Companies That are Hiring – June 2020 · BioBuzz

Despite the uncertainty created by the COVID-19 pandemic, companies across the BioHealth Capital Region (BHCR) continue to hunt for talented life science professionals to advance their technologies, produce their commercial products for the patients that need them, and for many they are also supporting COVID-19 vaccine and diagnostic efforts that the whole world is counting on.

We shouldn’t care who wins the vaccine ‘race’ – The Washington Post

Regarding the June 4 front-page article “Cold War echoes in race for vaccine,” about the “race” among nations, notably the United States, China, and Russia and other European nations for development of a vaccine against the novel coronavirus:

When communicating about vaccines and dates, leaders should be careful to note that this means candidate vaccines. We actually have a vaccine only after it is proved effective and safe over a long period, requiring time (years, not months), durability (e.g., the measles vaccine lasts a lifetime whereas some others are much shorter), a formula that covers all or most strains (especially those recurring seasonally) and feasibility (cost, global availability, etc.).

Covid-19 vaccine price controls would scare off developers, Fauci says at BIO – MedCity News

As multiple companies work to develop vaccines against the virus that causes Covid-19, it will be important for them to work with the federal government toward an understanding with regard to fair pricing, but outright price controls could risk scaring companies away, a doctor helping lead efforts to develop drugs and vaccines for the disease told biotech industry executives Tuesday.

Image: https://medcitynews.com

Johns Hopkins to resume on-campus lab research next week | Hub

Johns Hopkins University researchers will be permitted to resume on-site laboratory activities beginning next week, the first steps of a gradual resumption of on-campus activities envisioned in the weeks and months ahead as the university emerges from a monthslong period of distancing prompted by the COVID-19 pandemic.

Covid-19 roundup: Fauci talks pricing, disparate impact and the virus’s enduring mysteries; China to offer experimental vaccines to overseas workers – Endpoints News

Multiple vaccines will ultimately be approved for Covid-19, NIAID chief Anthony Fauci told BIO yesterday, and the companies that make them should be allowed to profit, “as long as it’s not in an outrageous way.” Sitting down for a rare extended interview with new BIO chief Michelle McMurry-Heath,

Image: NIAID chief Anthony Fauci (AP Images)Image: https://endpts.com

The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life | BIO

This ninth biennial TEConomy/BIO report focuses on the economic footprint of the industry geographically including the latest trends in the bioscience industry for the nation, states, and metropolitan areas. Check out state-by-state information on the performance of the bioscience economy.

Congratulations to Our Digital RESI June Innovation Challenge Winners! | Next Phase Newsletter

Our 3-day Digital RESI June conference came to an end yesterday, and we are very excited to announce the Top 3 Winners of the Innovation Challenge. Each participating finalist company had a dedicated page where you could view their virtual poster, short pitch, and other supplementary materials that the companies made available for viewing.

Producing Enough Vaccine For The Coronavirus Means Companies Have To Start Now : Shots – Health News : NPR

Once upon a time, developing a new vaccine was a step-by-step process that went from concept, to design, to tests in humans, to regulatory approval, to manufacturing.

It was a process that could take a decade or more.

But the urgent need for a COVID-19 vaccine has radically changed all that. Now, the hope is the entire process can be completed in a year or less.

Image: Cell culture operators prepare a 2000-liter single-use bioreactor to produce proteins used to make vaccines. Philip Taciak/Emergent Biosolutions

NIH announces $1 million prize competition to target global disease diagnostics

The National Institutes of Health has launched a $1 million Technology Accelerator Challenge (TAC) to spur the design and development of non-invasive, handheld, digital technologies to detect, diagnose and guide therapies for diseases with high global and public health impact. The Challenge is focused on sickle cell disease, malaria and anemia and is led by NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB). The Bill & Melinda Gates Foundation is cooperating with NIH to help accelerate the transformation of design concepts into products for low-resource settings.

Can you catch Covid-19 from someone without symptoms? — Quartz

On Monday, June 8, an official at the World Health Organization (WHO) made a surprising statement. People who have Covid-19 but are asymptomatic—meaning they never develop symptoms like fever, coughing, or gastrointestinal distress—very rarely gave it to others, stated Maria Van Kerkhove, the WHO’s technical lead on the Covid-19 pandemic, at a regularly-scheduled press briefing.

The very next day, the organization took it back. Some might have taken WHO’s original statement to mean that “stealth transmission” of Covid-19 is unlikely—that if a person isn’t actively coughing and sneezing, you don’t need to worry about getting infected. But that’s not necessarily the case. On June 9, WHO clarified that while most transmission seems to come from people showing symptoms, it’s too soon to know exactly how the virus spreads.

Image: AP PHOTO/PETROS KARADJIAS – https://qz.com/

BioHealth Capital Region Spotlighted at RESI

The BioHealth Capital Region featured at last week’s Redefining Early Stage Investments Conference (RESI) where speakers from the region discussed a range of topics of interest to early stage companies including:

For more information, check out the RESI Conference site or contact BHI.

Creatv Announces Ability to Predict Immunotherapy Treatment Response for Non-Small Cell Lung Cancer (NSCLC) using a Simple Blood Test | Business Wire

ROCKVILLE, Md.–(BUSINESS WIRE)–Creatv Microtech, a privately-held biotechnology company has pioneered a blood test to predict treatment response in patients with stage II-III NSCLC treated with chemoradiation therapy (CRT) and consolidated immunotherapy. Clinical data presented at the ASCO 2020 virtual annual meeting shows the ability to predict which NSCLC patients will benefit from anti-PD-L1/PD-1 immunotherapies. “We are delighted to present a method to stratify patients responding to immunotherapy by a single tube of blood collected after completion of CRT,” said Dr. Cha-Mei Tang, CEO of Creatv. “Early identification of patients that do not respond to immunotherapy will reduce unnecessary patient suffering from ineffective and costly treatment, allowing patients to proceed to alternative therapies.” Currently, no other blood test can predict immunotherapy treatment response for lung cancer.

AstraZeneca, Emergent BioSolutions sign $87M deal to produce U.S. supply of COVID-19 vaccine | FiercePharma

AstraZeneca made waves last week when it signed a massive $750 million deal to ramp production of a University of Oxford COVID-19 vaccine up to 2 billion doses per year. Now, as part of a Trump administration effort to get shots into U.S. hands as soon as possible, AstraZeneca has agreed to another major manufacturing tie-up.

Image: AstraZeneca agreed to dole out $750 million last week to boost its COVID-19 shot capacity to more than 2 billion doses. (AstraZeneca)

Apr 27 2020

Love0

411th Edition – June 23, 2020

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

June 23, 2020

FOUNDING MEMBER OF

Charles Andres and Christian Barrow join BioTalk to discuss investing, growth and the BioHealth Capital Region during COVID-19

Charles Andres, Ph.D., RAC, Associate at Wilson Sonsini Goodrich & Rosati, and Christian Barrow, Executive Director, Life Sciences Banking at JP Morgan, join Rich Bendis for a Virtual BioTalk

Charles Andres, Ph.D., RAC, is an associate in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati. He focuses on patent prosecution, strategic patent counseling, IP due diligence, drug and medical device FDA regulatory counseling, invalidity and non-infringement opinions, life-cycle management, Supreme Court and Federal Circuit amicus briefs, and related business matters.

The BioHealth Capital Region Featured at Digital RESI LSN Global Conference

The Life Science Network’s Digital Redefining Early State Investments (RESI) took place online June 8-10, 2020, and featured some of the most knowledgeable voices from the BioHealth Capital Region. The region was well represented across four panels titled:

AstraZeneca taps Catalent for COVID-19 vaccine finishing, packaging at Italian plant | FiercePharma

British drugmaker AstraZeneca is shooting for the moon with its plan to produce 2 billion doses per year of a potential COVID-19 vaccine. To reach that lofty goal, AstraZeneca has reached a deal with New Jersey-based Catalent to help with the final stages of the shot’s manufacturing.

Catalent will be tasked with finishing and packaging duties for AstraZeneca and the University of Oxford’s COVID-19 vaccine candidate, AZD1222, at its 305,000-square-foot manufacturing facility in Anagni, Italy, the CDMO said Monday.

Image: Catalent will be tasked with helping finish and package AstraZeneca’s COVID-19 vaccine candidate. (Catalent)

Emergent Bio to invest $75M in Canton site (NYSE:EBS) | Seeking Alpha

Emergent BioSolutions (NYSE:EBS) will invest $75M in its Canton, Massachusetts facility, focused on the development and manufacturing of drug substance for live viral vaccines and plans to expand into viral vector and gene therapy.

The investment will include a state-of-the-art, multi-suite operation up to 1000L scale.

Rexahn and Ocuphire Enter into Definitive Merger Agreement :: Rexahn Pharmaceuticals, Inc. (REXN)

ROCKVILLE, Md. and FARMINGTON HILLS, Mich., June 17, 2020 (GLOBE NEWSWIRE) — Rexahn Pharmaceuticals, Inc. (NasdaqCM: REXN) and Ocuphire Pharma, Inc., a privately-held clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of eye disorders, today announced the companies have entered into a definitive merger agreement under which Ocuphire will merge with a wholly-owned subsidiary of Rexahn in an all-stock transaction. Following closing, which is expected to occur in the second half of 2020, the combined company will change its name to Ocuphire Pharma, Inc. and is expected to trade on the Nasdaq Capital Market under the ticker symbol “OCUP.” The combined company will focus on the advancement of its pipeline of ophthalmic drug candidates.

Emmes Chosen as a Top Area Workplace

ROCKVILLE, Md., June 17, 2020 /PRNewswire/ — Emmes today announced that it was selected as one of the best places to work in the greater Washington area. The Washington Post’s 2020 Top Workplaces list ranked private, public, nonprofit and government agencies based on the highest engagement ratings from their employees.

The Washington Post partnered with employee research and consulting firm Energage, LLC, to conduct the survey, and the highest ranked workplaces were chosen based on employee responses about their own company. There were 3,500 area companies invited to participate, and 406 were surveyed. This is the seventh year the survey has been conducted.

Sirnaomics and Precision NanoSystems Have Formed a Partnership | BioSpace

Developing and Manufacturing Novel RNAi drug Candidates Using Precision NanoSystems’ NxGen™ Platform

GAITHERSBURG, MD and VANCOUVER, BC, June 17, 2020 /PRNewswire/ – Sirnaomics Inc. (Sirnaomics) and Precision NanoSystems Inc. (PNI) jointly announced a partnership on the development and manufacture of Sirnaomics polypeptide nanoparticle-based RNAi therapeutic product. This strategic joint effort includes the execution of a NanoAssemblr® platform license and supply agreement, plus successful production of multiple batches of Sirnaomics drug product candidates, STP705 and STP707, for ongoing IND enabling safety and toxicity studies, as well as several clinical studies.

ITI Enters into License Agreement with Ichor to Use Electroporation (EP) Delivery Technology in Phase I Study of DNA Vaccine Therapy, ITI-1001 – Immunomic Therapeutics

Children’s National Hospital ranked a top 10 children’s hospital and No. 1 in newborn care nationally by U.S. News for fourth year in a row

WASHINGTON, June 16, 2020 /PRNewswire/ — Children’s National Hospital in Washington, D.C., was ranked No. 7 nationally in the U.S. News & World Report 2020-21 Best Children’s Hospitals annual rankings. This marks the fourth straight year Children’s National has made the list, which ranks the top 10 children’s hospitals nationwide. In addition, its neonatology program, which provides newborn intensive care, ranked No.1 among all children’s hospitals for the fourth year in a row.

The Children’s National Hospital neonatology program, which provides newborn intensive care, ranked No.1 in the nation by U.S. News for the fourth year in a row.

Children’s National Hospital ranked a top 10 children’s hospital and No. 1 in newborn care nationally by U.S. News for fourth year in a row

Altimmune Announces IND Clearance for a Phase 2 Trial of HepTcell™ Immunotherapeutic for the Treatment of Chronic Hepatitis B | BioSpace

GAITHERSBURG, Md., June 22, 2020 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 2 trial of HepTcell, a peptide-based immunotherapeutic for the treatment of chronic hepatitis B. The Company is also filing clinical trial applications in Canada, Spain, Germany and the United Kingdom. Altimmune plans to initiate a multinational trial in Q4 of this year, subject to an ongoing assessment of the impact of COVID-19 on study conduct.

Preclinical Data for PRGN-3005 UltraCAR-T® Demonstrate Superior Expansion and Persistence of UltraCAR-T Compared to Traditional CAR-T | BioSpace

GERMANTOWN, Md., June 22, 2020 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced preclinical data for its innovative investigational PRGN-3005 UltraCAR-T® in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer has been published as an e-poster and accompanying audio presentation at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. The e-poster presentation titled PRGN-3005 UltraCAR-T: Multigenic CAR-T Cells Generated Using Non-viral Gene Delivery and Rapid Manufacturing Process for the Treatment of Ovarian Cancer (Abstract 6593) is part of the Immunology/Adoptive Cell Therapy session and is accessible on the AACR e-poster website.

Emergent to add gene therapy capacity – Bioprocess InsiderBioProcess International

Emergent Biosolutions has set out to capture a share of the expanding viral vector and gene therapy sector.

The US countermeasures developer said it will spend $75 million to add viral vector and gene therapy manufacturing capacity at a facility in Canton, Massachusetts.

At present the plant – which was acquired from Sanofi in 2017 – produces drug substance for live viral vaccines, including Emergent’s smallpox jab ACAM2000.

CrazyCap helps Martine Rothblatt Cheer On Her Team Through Crisis! – PharmiWeb.com

MIAMI, June 22, 2020 /PRNewswire/ — Esteemed lawyer, author, and entrepreneur, Martine Rothblatt, Ph.D., found a thoughtful and practical way to thank her employees at United Therapeutics, who have been going above and beyond during this time of the coronavirus crisis. The team at United Therapeutics, a biopharmaceutical company, has always been dedicated to working hard on life-saving biotech innovations. During the global coronavirus pandemic, United Therapeutics has recognized the dire need to develop treatments for COVID-19 patients and has responded quickly by initiating three projects intended to help with COVID-19, including an artificial lung technology that could help avoid the need for the use of ventilators.

Image: https://en.wikipedia.org/wiki/Martine_Rothblatt

GMU selects three finalists for $250M Institute for Digital InnovAtion | Virginia Business

George Mason University on Monday announced three development and property management firms as finalists to build and operate its proposed $250 million Institute for Digital InnovAtion (IDIA), set to open in September 2025 on its Arlington campus. The university released a request for proposals in February, to which 105 developers responded.

Image: Concept rendering of George Mason University’s Institute for Digital InnovAtion (IDIA) in Arlington – https://www.virginiabusiness.com

AstraZeneca agrees to make Covid-19 vaccine for Europe | BreakingNews.ie

Pharmaceutical giant AstraZeneca has struck a deal with Europe’s Inclusive Vaccines Alliance to supply up to 400 million doses of an experimental Covid-19 vaccine, as efforts to boost manufacturing capacity continue at pace.

The alliance, which was forged by Germany, France, Italy and the Netherlands to speed up production of a vaccine, is set to take delivery of the material being tested by the University of Oxford by the end of 2020.

University of Maryland Medical System awarded $18.7 million federal grant to fight coronavirus – Baltimore Sun

The University of Maryland Medical System will receive more than $18.7 million in funding from the Federal Emergency Management Agency (FEMA) in the ongoing effort to combat the coronavirus, the arm of the U.S. Department of Homeland Security announced Monday.

GSK gets FDA approval for HIV drug for children – MarketWatch

Shares of GlaxoSmithKline GSK, +0.36% were down 0.05% in premarket trading on Monday after the Food and Drug Administration late on Friday approved its HIV drug Tivicay as a treatment for infants and children. Tivicay is the company’s second-best selling drug in its HIV portfolio. About 2,200 children in the U.S. had been diagnosed with HIV in 2016, according to statistics provided by the Centers for Disease Control and Prevention. GSK’s stock has gained 14.9% since the start of the year. The S&P 500 SPX, -0.56% is down 5.8% year-to-date. The FDA is granting the approval of Tivicay and Tivicay PD to ViiV Healthcare.

Novavax Appoints Biotechnology Veteran David Mott to Board of Directors | Novavax Inc. – IR Site

GAITHERSBURG, Md., June 16, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has appointed David Mott as an independent director to its Board of Directors. Mr. Mott brings more than three decades of global management, board and investment experience across numerous private and public biopharmaceutical companies. Prior to February 2020, he was the global head of healthcare investing at New Enterprise Associates (NEA).

Advisory Board | Johns Hopkins Technology Ventures

The IDEA Board champions innovation and entrepreneurship across the Johns Hopkins University, providing the vision and strategy by which Johns Hopkins will bring the next generation of discoveries to market. This group of stakeholders from industry, academia, startups, and the broader ecosystem is also helping to catalyze new economic activity and partnerships that will build a better Baltimore.

GSK Expands Synthetic Lethality Scope With $120M Ideaya Bio Alliance – Xconomy

GlaxoSmithKline got its first taste of synthetically lethal cancer therapies via an acquisition. Now it’s trying for a bigger bite of this emerging drug class through a research alliance with Ideaya Biosciences that spans three of the biotech’s programs, all slated to reach clinical trials in the next three years.

Emergent BioSolutions Adding Approximately 300 Jobs After New COVID-19 Vaccine Contracts

Business is booming for Emergent BioSolutions as it has assisted in the country’s push to create COVID-19 treatments and vaccines. Emergent is developing two plasma-based treatments for COVID-19 and has partnered with four companies on vaccine candidates. It is additionally partnering with the Federal Government to develop and manufacture COVID-19 vaccines. As a result of this wave of new business, the company is hiring approximately 300 new employees in Baltimore and Rockville.

Emergent BioSolutions Enters Viral Vector And Gene Therapy Arena – Contract Pharma

Emergent BioSolutions has unveiled plans to strengthen its contract development and manufacturing (CDMO) capabilities by expanding into viral vector and gene therapy. The company will invest $75 million in its Canton, MA facility, which is focused on the development and manufacturing of drug substance for live viral vaccines, including the company’s smallpox vaccine.

Lockheed’s ventures arm backs quantum computing and training tech firms — Washington Technology

Lockheed Martin Ventures — the defense company’s technology startup investment arm — has backed two companies through separate avenues announced this week.

In a release Tuesday, quantum computing company IonQ said it grew its total fundraising amount to $84 million through a new Series B round that represents its second significant round of investments since the 2015 founding with $2 million in seed money.

Image: https://washingtontechnology.com

Royalty Pharma, drug firm that doesn’t develop drugs, shatters IPO record

Royalty Pharma, a business built on investing in other people’s medicines, raised $2.2 billion in a record IPO on Tuesday, and the early hours of trading boosted its valuation to more than $25 billion.

The company, founded in 1996, priced about 78 million shares at $28 each. Royalty Pharma opened trading at $44, an instant 57% increase, suggesting the company’s bankers left a fair amount of money on the table.

BIA | EPIDAREX CAPITAL CLOSES NEW £102 MILLION UK VENTURE FUND TO BUILD SUCCESSFUL LIFE SCIENCE COMPANIES

Edinburgh, UK, 22 June 2020 – Epidarex Capital (“Epidarex”), a transatlantic life science venture firm, announces that it has closed Epidarex Capital III UK LP (the “Fund”) at £102.1 million. The Fund will build new life science companies based on world-class research and innovation from emerging hubs across the UK, including spinouts from highly regarded universities. Typical initial investments will range from £2 million to £5 million.

BHI Weekly Newsletter Archives

About BioHealth Innovation

Contact

Connect

BHI Weekly Newsletter Archives

About BioHealth Innovation

Contact

Connect

Search