News Archive

The contract from BARDA will advance development of an antibody cocktail therapeutic for the treatment of smallpox.

FREDERICK, MD. (PRWEB) JULY 15, 2022

BioFactura today announced its second contract option activation of $15.9 million from the Biomedical Advanced Research and Development Authority (BARDA) to advance development of an antibody cocktail therapeutic for the treatment of smallpox.

This funding is part of BioFactura’s prime contract valued at up to $68.2 million for the advanced development of its smallpox biodefense therapeutic. This contract option will provide an accelerated path for product development leading to the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for first-in-human studies.

July 18, 2022, Baltimore, MD – Materic, a custom manufacturer of advanced materials, and LaunchPort, LLC, a medical device venture center and GMP contract manufacturing operation today announced a partnership to drive the use of advanced materials in the development of emerging medical device technologies.

GAITHERSBURG, Md., July 06, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company’s board of directors appointed Sujata Dayal as a Class II director to serve on the board effective July 15, 2022, with an initial term expiring at the 2023 annual meeting of stockholders. Ms. Dayal was also appointed as a member of both the Nominating and Corporate Governance Committee and the Special Committee on Manufacturing and Quality Oversight.

A new CBRE report ranked the top 25 life sciences research talent clusters for the first quarter.

Tustin, California, July 11, 2022 (GLOBE NEWSWIRE) — Canon Medical Systems USA Inc., a commercial subsidiary of Canon Medical Systems Corporation and a global leader in innovative diagnostic imaging technology, today announces it has signed a definitive agreement to acquire NXC Imaging, a medical imaging equipment distributor and service provider headquartered in Minneapolis, Minnesota. Founded in 1964, NXC Imaging’s distributorship area spans the U.S. Upper Midwest. The acquisition is expected to close in the third quarter of the 2022 calendar year.

• First IND for NexImmune’s AIM nanoparticle platform in solid tumors
• IND clearance enables commencement of a clinical trial to evaluate NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), in patients with relapsed or refractory human papillomavirus (HPV)-related cancers

GAITHERSBURG, Md., July 14, 2022 (GLOBE NEWSWIRE) — NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, has received IND clearance for the Company’s first cellular therapy product candidate addressing solid tumors.  NEXI-003, an autologous antigen-specific T cell product (CD3+/CD4-), is being developed for patients with relapsed or refractory human papillomavirus (HPV)-related cancers.

Kristi Jones, NexImmune’s CEO, commented, “The FDA clearance of our third IND marks another significant milestone for NexImmune and demonstrates our team’s continued focus and commitment to bringing novel therapies to patients with significant unmet need.  NEXI-003 is our third T cell therapy and first candidate to address solid tumors. NEXI-003 consists of T cell populations simultaneously directed against multiple HPV tumor-relevant antigen targets.  The T cells in our product candidate will consist of T cell subtypes critical to both potential anti-tumor activity and a phenotype intended to produce long-term immunologic memory required for durable responses.”

The announcement comes days after the Biden administration reached a deal to buy 3.2 million doses.

Image: Novavax has received emergency use authorization from the Food and Drug Administration for its two-dose Covid vaccine. MATTHEW FELDMAN

· Glioblastoma multiforme is one of the most complex, deadly and treatment-resistant cancer with a 5-year survival rate of 6.8% and an average length of survival of only 8 months *

· FDA ODD designation bolsters NeoImmuneTech’s determination to accelerate the clinical development of NT-I7 as a potential new therapy for this difficult-to-treat cancer

ROCKVILLE, Md, July 13, 2022 /PRNewswire/ — NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation for the treatment of Glioblastoma Multiforme.

Despite decades of research, GBM remains one of the deadliest and hardest-to-treat cancers. More than 13,000 Americans are expected to be diagnosed with GBM in 2022.1 Standard treatments using surgery, radiation, TMZ and TTFs have failed to date to greatly improve survival, and there is no standard treatment for recurrence, which is inevitable. Also, among the multiple factors impacting the survival of GBM patients, the current treatment options expose patients to a severe and prolonged systemic lymphopenic state known as “treatment-related lymphopenia” (TRL). TRL is associated with shorter survival both in GBM and other solid tumors. With its potential to restore lymphocyte levels and subsequently reverse systemic lymphopenia, NT-I7 may offer promising ways to effectively treat GBM, if confirmed by its development program.

Jul 11, 2022

Agreement will provide the first protein-based vaccine option in the U.S., pending FDA Emergency Use Authorization and CDC recommendation
GAITHERSBURG, Md., July 11, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced an agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to secure an initial 3.2 million doses of Novavax’ COVID-19 vaccine (NVX-CoV2373) should it receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and a recommendation from the Centers for Disease Control and Prevention (CDC). Novavax’ protein-based vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

“We are pleased to come one step closer to potentially offering our vaccine to physicians, healthcare organizations, and consumers who have been awaiting a protein-based vaccine option,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We are grateful for the U.S. government’s ongoing support and partnership to bring Novavax’ COVID-19 vaccine to the U.S., and we look forward to the FDA’s decision on an emergency use authorization.”