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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.

 

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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.

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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.

 

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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.

 
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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.

 

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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.

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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.).

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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

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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.

 

Banners and Alerts and 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/

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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)

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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.

 

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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

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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.

 

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). 

 

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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.

 

Roundcube Webmail NYC Builds Bio AURP Post Blast v03 pdf

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

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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.

 

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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.

 

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

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)

RNAimmune

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 ...

 

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.

 

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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.

 

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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

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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. 

 

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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 PRESS RELEASE 06 15 20 pdf 1 page

<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:

Ampel Bio Solutions, LLC

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.

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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 This email address is being protected from spambots. You need JavaScript enabled to view it.