News Archive

• 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.”

LG Chem to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its T-cell therapy candidates for solid tumors

GAITHERSBURG, Md., July 12, 2022 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, today announces the signing of a strategic platform license (SPL) with LG Chem Ltd., a globally diversified chemical company established in petrochemical, advanced materials and bio-technology, aiming to create new value for its customers based on science.

AmerisourceBergen, one of the top pharmaceutical distributors, is investing $150 million in a corporate venture fund focused on healthcare startups.

The wholesale giant’s new VC fund, called AB Health Ventures, will initially look to invest in early to midstage health-related startups both in the U.S. and abroad. The fund will prioritize investments in startups focused on innovation in pharmacy and distribution, clinical development and commercialization of pharmaceuticals, practice solutions for healthcare providers and animal health, executives said in a press release.

WASHINGTON  –  To advance quantum network capabilities and leadership, the U.S. Naval Research Laboratory (NRL) announced work with five other U.S. Government agencies on May 18 to establish the Washington Metropolitan Quantum Network Research Consortium (DC-QNet) to create, demonstrate and operate a quantum network as a regional testbed.

Quantum networks, an emerging research frontier, will one day offer the ability to distribute and share quantum information securely among quantum computers, clusters of quantum sensors and related devices at regional and national distances. They can also be used to distribute ultra-precise time signals, and offer the potential to enable the creation of new applications not yet imagined.

Image: https://www.nrl.navy.mil/

With the support of its homegrown Johns Hopkins Technology Ventures (JHTV), Baltimore’s oldest private university has helped many of its own students and faculty bring their technological innovations to market — and with wildly successful results. Now, JHTV has a new guide to make the process even easier for those within and beyond its namesake school’s community to understand.

Image:  Inside a Johns Hopkins Technology Ventures FastForward innovation hub. (Courtesy photo)

Kubanda Cryotherapy cofounder Bailey Surtees was building the foundation for her company as an undergraduate at Johns Hopkins University (JHU) before she knew it. In 2016, she was researching how to make breast cancer treatment more affordable and accessible for low- and middle-income countries. Surtees surmised that cryotherapy was the ideal solution because it doesn’t require a sterile operating room or anesthesia. Thus, she began developing a probe that could be used for this treatment.

Image:  The team behind TEDCO’s Maryland Innovation Initiative. (Courtesy photo)