BioHealth Innovation Weekly for May 14, 2024

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May 14, 2024

Novavax and Sanofi Announce Co-exclusive Licensing Agreement to Co-commercialize COVID-19 Vaccine and Develop Novel COVID-19-Influenza Combination Vaccines

GAITHERSBURG, Md., May 10, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M^™ adjuvant, has entered into a co-exclusive licensing agreement with Sanofi (Nasdaq: SNY).

The terms of the agreement include: a co-exclusive license to co-commercialize Novavax's current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan and South Korea where Novavax has existing partnership agreements); a sole license to Novavax's adjuvanted COVID-19 vaccine for use in combination with Sanofi's flu vaccines while Novavax retains the right to and is developing its own COVID-19-Influenza Combination vaccine candidate; a non-exclusive license to use Novavax's adjuvanted COVID-19 vaccine for use in combination with non-flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority (<5%) equity investment in Novavax.

NextStep Robotics Wins Pitch Dingman Competition Grand Prize, Announces New Board Members

BALTIMORE, MD – May 13, 2024 – NextStep Robotics, a University of Maryland, Baltimore (UMB) spinout company dedicated to commercializing cutting-edge stroke rehabilitation technologies, was awarded the $20,000 Grand Prize in the 2024 Pitch Dingman Competition’s All Stars Track. The signature annual competition is hosted by the Dingman Center for Entrepreneurship, part of the Robert H. Smith School of Business at the University of Maryland, College Park.

NextStep is also pleased to announce the appointment of new board members. These expert business executives bring a wealth of experience in the healthcare and technology sectors, which will be invaluable as NextStep Robotics continues to grow.

Linshom Medical Chosen by the NIH to Attend the Angel Capital Association Annual Meeting

BALTIMORE, MD, US, May 10, 2024 - Linshom Medical, a Maryland based start-up medical device company was selected as one of eight companies to represent the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant portfolio at the Angel Capital Association (ACA) annual meeting in Columbus, OH on May 13-15, 2024.

After a competitive evaluation of 190 applications, Linshom Medical was chosen by the National Heart Lung & Blood Institute (NHLBI) as 1 of 8 companies to represent an NIH portfolio of over 1,000 companies.

Welldoc Named “Best Overall Digital Health Company” for Second Consecutive Year in the 8th Annual MedTech Breakthrough Awards Program

COLUMBIA, Md., May 9, 2024 — Welldoc^®, a leading digital health company specializing in cardiometabolic health, today announced that it has been selected as winner of the “Best Overall Digital Health Company” award for the second consecutive year in the 8th annual MedTech Breakthrough Awards. The awards program is conducted by MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global digital health and medical technology market. This is the third year that MedTech Breakthrough has recognized Welldoc for its leadership and innovation in the digital health industry.

The AI-powered Welldoc platform offers flexible, multi-condition digital coaching across diabetes, weight management with GLP-1 support, hypertension, heart failure, and prediabetes, with integrated mental wellbeing and sleep guidance. Through personalized, real-time and actionable insights, the platform empowers individuals to better self-manage their health and provides care teams with critical data to inform clinical decision-making.

Stem Cell Research Shines at Maryland Stem Cell and Regenerative Medicine Tech Showcase

COLUMBIA, MD (May 8, 2024) – Maryland’s leading edge in stem cell research was on full display at the Maryland Stem Cell and Regenerative Medicine Technology Showcase (“Showcase”) on April 25, 2024. This event, hosted as a collaborative effort between Maryland Stem Cell Research Fund (MSCRF) and the Maryland Department of Commerce, served as a platform to highlight groundbreaking advancements in stem cell and regenerative medicine from MSCRF portfolio members.

“This is an exciting time in the regenerative medicine space and the Maryland Stem Cell Research Fund is honored to support the innovations in stem cell therapy taking place in Maryland,” said MSCRF executive director, Ruchika Nijhara, PhD. “Maryland is home to pivotal and innovative stem cell research, and we are pleased to partner with the Department of Commerce to bring the regenerative medicine community together to share their cutting-edge research in this growing field.”

Kite and Arcellx Continue Momentum with Advances in Anito-Cel Multiple Myeloma Program

REDWOOD CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder.

The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody.

Kite’s facility in Frederick, Maryland will manufacture anito-cel for this trial. This follows the completion of the technical transfer from a third-party contract manufacturing organization to Kite, as well as the transfer of the Investigational New Drug (IND) application for anito-cel, which has been cleared by the U.S. Food and Drug Administration.

Danaher Launches Collaboration with Johns Hopkins University Aiming to Improve Neurological Diagnosis

WASHINGTON, May 9, 2024 /PRNewswire/ -- Danaher Corporation (NYSE: DHR), a global science and technology innovator ("Danaher"), today launched a collaboration with Johns Hopkins University aiming to develop new methods for diagnosing mild TBI. As part of the Danaher Beacons program, researchers at Johns Hopkins University will leverage technology from Beckman Coulter Diagnostics, a Danaher subsidiary and leader in clinical diagnostics, to potentially establish correlations between a new biomarker panel and clinical outcomes.

Julie Sawyer Montgomery, Vice President and Group Executive, Danaher Diagnostics, said: "Our latest in vitro diagnostics innovations are improving the detection of specific biomarkers found in blood when brain cells are damaged. We are thrilled to partner with Johns Hopkins with the goal of leveraging these solutions to develop tests for earlier and more precise diagnosis of mild TBI, which could ultimately lead to improved treatment outcomes and faster recovery for patients."

Caring Cross and ImmunoAdoptive Cell Therapy (ImmunoACT) Announce Agreement to Commercialize TriCAR-T Cell Immunotherapy for Leukemia and Lymphoma

Agreement allows ImmunoACT to develop and commercialize a novel TriCAR-T cell therapy for leukemia and lymphoma designed to decrease lapses seen in current single CAR-T cell therapies and improve outcomes

GAITHERSBURG, Md. and MUMBAI, India, May 7, 2024 /PRNewswire/ -- Caring Cross, a 501(c)(3) non-profit dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients, everywhere, and ImmunoAdoptive Cell Therapy (ImmunoACT), a Mumbai, India-based pioneering research and cell and gene therapy development company, announced an agreement to develop and commercialize a multi-targeted chimeric antigen receptor T-cell immunotherapy for leukemia and lymphoma. The TriCAR-T immunotherapy is designed to address relapse that can occur when patients with Leukemia or Lymphoma are treated with a single targeting anti-CD19 CAR T-cell product. Under the terms of the agreement, Caring Cross will provide a TriCAR-T cell immunotherapy for clinical development, manufacturing, and commercialization at ImmunoACT's facilities in India.