421st Edition – September 1, 2020

Are you seeking an opportunity to engage your firm in a fun community-building activity?  Register one or more teams for the FRAXA Biotech Games.  The BioHealth Capital Region has been challenged by other clusters to demonstrate the greatest knowledge of biotech trivia. Proceeds benefit FRAXA Research Foundation, supporting Fragile X research projects at institutions around the world, including MIT, Harvard, Stanford and UCSD. Fragile X is the most common inherited cause of autism and intellectual disabilities.  BioHealth Innovation (BHI) is hosting the BioHealth Capital Region (Maryland, DC, and Virginia)’s participation in this exciting new event.   

Register one team or multiple teams this month to compete for the Cup in September!

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Economic Alliance of Greater Baltimore (EAGB), President and CEO, Michele L. Whelley, joins BioTalk to discuss her career, the economic development environment in Baltimore, and how to create a greater sense of partnership between perceived competing regions.

Listen now via Apple https://apple.co/2DikZfg, Google https://bit.ly/2Exq5oD , Spotify https://spoti.fi/31GmIUV, TuneIn https://bit.ly/32FjGQ5, and YouTube Audio https://bit.ly/31IwGFl.

Michele L. Whelley, President & CEO, is an economic development professional who is well-known throughout the region’s business community, Whelley brings new energy and focus to marketing the region, ensuring that EAGB will continue to strengthen its marketing platform as a critical component of fostering and supporting a vibrant and growing economy throughout the Greater Baltimore region.   

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Don’t miss your chance to be named the BioHealth Startup with the Most Commercial Potential at the BHCR Forum, win $10,000 and more!

CONSIDERATIONS:

• Technical Feasibility and IP
• Commercialization and Marketing Strategy
• Leadership Team and Collaborations
• Funding to Date and Financial Projections

CRITERIA:

• Demonstrated Proof of Concept/MVP
• Have received funding (dilutive/nondilutive)
• Understand regulatory and reimbursement hurdles
• A clear path to market and scalable

PREVIOUS WINNERS:

Sonavex

LifeSprout

Galen Robotics

Floreo

Applications due: 9/15

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

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CAMBRIDGE, Md. and LONDON, Aug. 26, 2020 (GLOBE NEWSWIRE) — OS Therapies, and late-stage clinical research biotechnology company focused on Osteosarcoma and other solid tumors today announced the co-exclusive licensing of BlinkBio’s novel Si-Linker and Cassette Payload technologies, and exclusive licensing of the BlinkBio technology to target Folate Receptor Alpha (FRα) for tumors and other targeted diseases.

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GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine.

“We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world.”

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GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) — Arcellx today announced the award of an EvansMDS Discovery Research Grant to Johns Hopkins University to support development of an Arcellx ARC-sparX therapy in the treatment of high-risk myelodysplastic syndromes (MDS). The collaborative effort, led by Amy E. DeZern, M.D., at the Johns Hopkins University School of Medicine, aims to advance development of ACLX-002, an immune cell therapy candidate directed at the therapeutic target CD123. The collaboration includes research to be conducted by Craig Jordan, Ph.D., of the University of Colorado School of Medicine, and materials and expertise to be contributed by Arcellx.

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ROCKVILLE, Md., Aug. 25, 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 the clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate the suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy (DR). The IND is active, and REGENXBIO plans to begin dosing patients in a Phase II trial, ALTITUDE, in the second half of 2020.

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(Reuters) – Catalent Inc said on Monday its Maryland facility would make the drug substance used in the COVID-19 vaccine being developed by AstraZeneca Plc and the University of Oxford, starting “late in the third quarter” this year.

The New Jersey-based company said the drug substance will be made at its commercial gene therapy manufacturing facility in Harmans.

Catalent would supply the so-called viral vector, which is a genetically modified harmless virus designed to trick the human body into producing certain parts of the coronavirus. These proteins, in turn, prompt the immune system to develop an arsenal for any real COVID-19 infections.

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A huge portion of a campus in Research Triangle Park has been sold in a deal that tops $590 million.

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Qiagen has announced plans to launch a new digital test for COVID-19 antibodies that can run multiple samples at once on a small portable device and deliver results in about 10 minutes.

With a small digital hub and interchangeable testing stick system, the eHub was developed for use against the novel coronavirus in collaboration with Australian diagnostic developer Ellume. The device can process up to eight samples simultaneously, or up to 32 tests per hour, to detect the presence of IgA, IgM or IgG antibodies in plasma or serum.

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GAITHERSBURG, Md., Aug. 26, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company’s board of directors appointed Marvin L. White as a Class II director to serve on the board effective October 1, 2020, with an initial term expiring at the 2023 annual meeting of stockholders. Mr. White was also appointed as a member of both the Scientific Review Committee and Strategic Operations Committee of the board.

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SOMERSET, N.J. – Aug 24, 2020 — Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that Catalent Cell & Gene Therapy will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland.

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Imagine being able to use science to choose the right music for an advertising campaign or being able to order food and groceries on a military base from a veteran-owned small business.

Hampton Roads startups are bringing these ideas and more to this year’s 757 Accelerate program. In the midst of a global pandemic, the region’s startup accelerator is moving its entire program online and implementing a new abridged program for three more area startups.

Image: From left, Secret Chord Laboratories founders Scott Miles, David Rosen and Robert Abelow will be participating in the third 757 Accelerate startup program. Due to the coronavirus pandemic, the program will be switching to operating virtually this year. (Courtesy photo)

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Coronavirus made 2020 the year of the pivot.

But the D.C.-area ventures having real, direct impact on the Covid-19 crisis have done more than tweak their business models; they’re innovating, persevering and committing to getting us through the pandemic in one piece.

They’re laying groundwork and executing on plans to tackle the disease. They’re developing resources and launching initiatives to serve our communities, as we grapple with dangerous and disruptive ripple effects born from the public health emergency. They’re conducting research, donating dollars and delivering on their promises, all with one goal: to push through this period and make life easier in the interim, and thereafter.

Image: Coronavirus has challenged the region’s businesses to step up. fpm – https://www.bizjournals.com

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In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has transformed the way people usually do business in the sector.

Image: Peter Meath – https://medcitynews.com

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Humans are not the only species facing a potential threat from SARS-CoV-2, according to the results of a study by an international scientific team headed by researchers at the University of California, Davis (UC Davis). Using genomic analysis to compare the amino acids of a key part of the ACE2 protein that is used by SARS-CoV-2 to gain entry into human cells, with those of the ACE2 protein in more than 400 other animals, the team found it feasible that many different species, including some, like the Western lowland gorilla, which are highly endangered, could potentially be infected by the virus.

Image: Western lowland gorilla (Trisha Shears/FreeImages)

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The United States aims to invest $765 million over the next 5 years in a dozen scientific centers dedicated to the study of artificial intelligence (AI) and quantum information science (QIS), such as quantum computing, the White House announced today. Numerous private tech companies such as IBM, Google, and Intel will also contribute to the twin pushes, which call for a total of more than $1 billion in research investment.

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The US National Institutes of Health (NIH) is one of the largest early stage life sciences investors, and funds over $1B in awards each year through its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programmes, according to NIH representatives who spoke at the “Key Role of NIH in the Product Development Pipeline” panel session at the Biotechnology Innovation Organization (BIO) Digital International Convention on 9 June.

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OxiWear’s own founder is a user herself of its oxygen monitor for patients with severe pulmonary hypertension.

Image: Shavini Fernando is founder and CEO of OxiWear. LESLIE E. KOSSOFF/GEORGETOWN UNIVERSITY

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