Biohealth Innovation
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.
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.
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.
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."
Excited to announce that TruGenomix just won Start Up of the Year Pitch Event. Great pitch Charles Cathlin !!!!! #SDVOB #ptsd #TruGenomix #veteranshelpingveterans
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.
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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.
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.”
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
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.
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.)
“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.
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.
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.”
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™ 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.
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)
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)
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.
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.
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."
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.
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.
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.
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
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
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.
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.
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.
Montgomery College announces several pop-up, remote classes which could be valuable for you and your teams: :
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.
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.
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.
“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)
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.