486th Edition, December 14, 2021

ROCKVILLE, Md., Dec. 08, 2021 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s Disease (PD).

Following the original submission of the NDA for SPN-830, the U.S. Food and Drug Administration (FDA) issued a Refusal to File (RTF) letter in November 2020 indicating that the NDA was not sufficiently complete to permit a substantive review. The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021

• Initial Phase 1/2 data presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition 
• Phase 1/2 study of NEXI-002 as a monotherapy in patients with relapsed/refractory multiple myeloma patients who have failed ≥3 prior lines of therapy is ongoing

GAITHERSBURG, Md., Dec. 12, 2021 (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, today announced preliminary Phase 1/2 results from an ongoing study of NEXI-002, a patient-derived multi-antigen-specific CD8+ T cell treatment for patients with relapsed/refractory multiple myeloma who have failed ≥3 prior lines of therapy. The data on low doses of NEXI-002, presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, showed a promising safety and tolerability profile and evidence of immunologic and clinical activity.

COLLEGE PARK, Md., December 07, 2021–(BUSINESS WIRE)–IonQ, Inc. ("IonQ") (NYSE: IONQ), a leader in trapped-ion quantum computing, today announced its participation at the fifth Q2B Practical Quantum Computing Conference (Q2B 2021). On the heels of multiple recent milestones, the IonQ team will discuss strategies and tactics for a successful enterprise partnership approach, as well as practical machine learning applications as the team paves the way for quantum computing commercialization.

We work alongside our entrepreneurs as partners to drive the next wave of startups. We leverage our diverse operating and investing experience to uncover opportunities to add value throughout the life cycle of our portfolio companies. Our goal is to meaningfully contribute to the greatest shared outcomes.

Innoforce (“INF”), a biopharmaceutical manufacturing & development company, announced today the completion of a 1 billion CNY ($156.6M) Series A financing, with the closing of an additional 375M CNY ($58.7M) following the first tranche of 625M CNY ($96M) completed in March 2021.

The Series A financing round was co-led by Yanchuang Capital and South China Venture Capital (SCVC) with additional investment from existing investor Quan Capital Management. In the most recent tranche, Yanchuang Capital increased its investment and additional investors joined, including Advantech Capital, Triwise Capital, CICC Capital, Highrun Capital, Euland Venture, S&G CAPITAL and others.

The critical shortage of “wet lab” space in Baltimore is an indictment of a city economic development strategy more concerned with real estate development than with job development (”Baltimore officials hoping to address shortage of ‘wet lab’ space to retain more innovators,” Nov. 15). Colin Tarbert, head of the Baltimore Development Corporation, warned that the shortage jeopardizes the city’s ability to retain existing life science companies, let alone attract new ones.

Image: https://www.baltimoresun.com/opinion/readers-respond/bs-ed-rr-wet-labs-letter-20211206-dgtyymlxqrbgnijb4xg277gpje-story.html

SAN JOSE, Calif. & BETHESDA, Md.–(BUSINESS WIRE)–Accellix Inc., which provides quick and accurate flow cytometry results in a compact and easy-to-use platform designed for use by cell therapy companies on the manufacturing floor and at the point-of-need, today announced that it has raised $10 million from BroadOak Capital Partners.

BroadOak is known for its flexible growth capital and M&A advice for life sciences tools and services companies. The investment is part of BroadOak’s fifth fund and marks the firm’s third investment in the last six months in the rapidly growing market of tools and services for cell and gene therapy development and manufacturing. BroadOak previously invested in Accellix as part of a prior fund.

Monoclonal antibodies have become one of humanity’s most powerful, multi-use tools in biology and medicine. Once the field of immunology established that they could be produced to bind very specifically to almost any suitable substance, science has had a means of detecting and/or purifying those substances or, in the case of viruses, identifying the antibodies that will serve as effective treatments. And in these times of pandemic, tools to detect viruses such as SARS-CoV-2 at the point of care and produce novel vaccines are more important than ever. 

Image: Dr. James Crowe, Vanderbilt University Medical Center, Nashville, Tennessee

• Initial Phase 1/2 data presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition 
• Phase 1/2 study of NEXI-002 as a monotherapy in patients with relapsed/refractory multiple myeloma patients who have failed ≥3 prior lines of therapy is ongoing

GAITHERSBURG, Md., Dec. 12, 2021 (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, today announced preliminary Phase 1/2 results from an ongoing study of NEXI-002, a patient-derived multi-antigen-specific CD8+ T cell treatment for patients with relapsed/refractory multiple myeloma who have failed ≥3 prior lines of therapy. The data on low doses of NEXI-002, presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, showed a promising safety and tolerability profile and evidence of immunologic and clinical activity.

Our internal 24-hour circadian clock regulates many aspects of physiology, including the response to infectious disease and vaccination. A new study published in the Journal of Biological Rhythms demonstrates that antibody levels are higher when people receive the SARS-CoV-2 vaccine in the afternoon versus the morning.

Image: https://news.harvard.edu/

The transition from Angel to institutional funding is a key step (but not quite an absolute requirement) in the evolution of a start-up bringing a new device to market. Broadening investments accompany deepening organizational sophistication, as start-ups more and more take on the business and regulatory trappings of larger device companies. However, even the best medical devices proposed by the best founding teams must cross the most critical governing threshold before reaching the market.

Image: https://medium.com

BD has settled on a new name for its new company, the independent spinout that will house its billion-dollar diabetes care business. 

Embecta is set to launch as its own, publicly traded brand in the second quarter of 2022 after almost a century of supplying a portfolio of insulin pens and syringes under the BD banner. The diabetes division contributed about 6% of the company’s revenues in the 2020 fiscal year, or nearly $1.1 billion, by serving about 30 million users worldwide.

Image: Carrying over the “bect” in its logo as a nod to Becton, Dickinson and Company, embecta will maintain international manufacturing sites that previously produced around 8 billion injection devices annually. (BD)

Health and Human Services Secretary Xavier Becerra today announced that Lawrence A. Tabak, D.D.S., Ph.D., the principal deputy director of the National Institutes of Health (NIH), will serve as the acting director of NIH effective December 20, 2021.  

Earlier this year, current NIH director Francis S. Collins, M.D., Ph.D., announced his decision to end his tenure as the NIH director by the end of the year, and his last day as director will be December 19, 2021.  Dr. Collins is the longest-serving, presidentially-appointed NIH director, having served three U.S. presidents over more than 12 years.