Biohealth Innovation - 493rd Edition, February 1, 2022

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February 01, 2022

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BioHealth Innovation Announces Updates to its Board of Directors

Board of Directors Elects New Chair, Vice-Chair, and Two New Members

ROCKVILLE, MARYLAND, January 31, 2021 – The Board of Directors of BioHealth Innovation, Inc. (BHI) unanimously approved the appointment of Peter S. Briskamn, Executive Managing Director and Mid-Atlantic Life Sciences Practice Co-Lead for JLL, and Christine Dingivan, M.D., President and Chief Executive Officer for Emmes as the new Chair and Vice-Chair in 2022. In addition, Ronald C. Kurz, Senior Director/GM for Canon Virginia, Inc. (CVI), and Dr. Tyrell Rivers, Executive Director of Corporate Development & Ventures at AstraZeneca, will be joining the Board as new members.

BioHealth Innovation and its Board of Directors would also like to thank outgoing Chair Jarrod Borkat for his leadership as he will remain with the Board. The Board would also like to thank Rebecca Farkas, Ph.D., for her contributions as she departs GSK and moves into a new role with CEPI.

"We are proud to announce Pete and Christine as our new Chair and Vice-Chair on the BHI Board of Directors," said Richard Bendis, BHI President and CEO. "Their experience and industry knowledge, plus the additions of Ron and Tyrell are important pieces to not just BHI, but the continued growth of the BioHealth Capital Region."

Immediate Job Opportunity: Entrepreneur-In-Residence Role with BioHealth Innovation, Inc. and NIH

POSITION DESCRIPTION – Entrepreneur-In-Residence

EIRs will work in collaboration with SEED to mentor innovators and provide guidance to help them de-risk the technical and business elements of their product development projects. EIRs will also help NIH and individual innovators ensure the long-term success of their projects by facilitating connections with investors and strategic partners who can help achieve commercial success and healthcare consumer access. To be successful in this role, entrepreneurial, commercial or product development experience in areas of social impact including wellness & prevention, healthcare access/community health and a wide network in social impact ventures is required.

This position is currently remote (with opportunity for future in-person activities) and part time (20 hrs/week with potential for expansion); occasional travel may be required (when conditions permit).

Learn more

BHI’s next EIR Feedback Day is February 16th

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

Entrepreneurial Development | Seed

The SEED Innovator Support Team helps NIH awardees build a business and explore their life science innovation's potential. Learn about the aspects of product development beyond the science of the awards. 

Regulatory & Business Development Consultations

Our business development, intellectual property, regulatory, and reimbursement experts meet with innovators focused on topics including:

Optimizing formulation or manufacturing operations
Establishing an advisory board 
Layering intellectual property protection
Preparing for regulatory interactions
Gathering evidence to support reimbursement value
Engaging with investors or strategic partners

Cartesian Therapeutics Doses Patient with First Allogeneic RNA Cell Therapy for Multiple Myeloma - Cartesian

Gaithersburg, Md., January 25, 2022 – Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, today announced that it has dosed the first patient in a Phase 1/2a multicenter clinical study evaluating Descartes-25 in patients with multiple myeloma. To the company’s knowledge, Descartes-25 is the first off-the-shelf RNA cell therapy to enter clinical trials for any cancer and marks the company’s fifth FDA Investigational New Drug (IND) allowance in five years. Descartes-25 is produced at Cartesian’s wholly owned cGMP manufacturing facility with the company’s proprietary RNA Armory® cell manufacturing platform. This platform now includes an internally developed, Part 1271-compliant Master Cell Bank of human umbilical cord Mesenchymal Stem Cells (MSC) that was used to engineer Descartes-25.

QIAGEN Completes U.S. Federal Contract to Equip Local Public Health Authorities with QIAcuity Digital PCR System for COVID-19 Surveillance | BioSpace

HILDEN, Germany, & GERMANTOWN, Md.--(BUSINESS WIRE)-- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has completed a U.S. government contract to equip public health laboratories across the country with the QIAcuity digital PCR system to monitor the spread of the COVID-19 pandemic by testing wastewater for the presence of SARS-CoV-2 pathogens.

QIAGEN has shipped more than 35 QIAcuity systems to state and local health laboratories as part of a multi-million-dollar contract with the U.S. National Institutes of Health (NIH) to supply COVID-19 instruments and consumables through the end of 2021.

Pandemic Preparedness: The next best time to act is now – Emergent BioSolutions

Global public health is at a critical inflection point. Do we learn the lessons of this pandemic and build a modern public health infrastructure to prepare us for the next one? Or do we repeat the mistakes of the current and past pandemics?

This week, Senate HELP Committee Chair Patty Murray and Ranking Member Richard Burr released a bipartisan draft bill aimed at evolving America’s pandemic preparedness commensurate with the challenges we face. The bill adds to the important public policy conversation ongoing in Washington, which includes President Biden’s ambitious $65 billion initiative for preparedness.

Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine

NVX-CoV2373 demonstrated overall efficacy of ~90% in PREVENT-19 clinical trial conducted during the emergence of variant strains

GAITHERSBURG, Md., Jan. 31, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a request to the U.S Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its protein-based COVID-19 vaccine candidate for immunization of individuals 18 year of age and older against SARS-CoV-2.

The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile.

"We're extremely proud of the work of our teams and we look forward to FDA's review of our EUA request. We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "I'd like to also extend our thanks for the support of the U.S. Department of Health and Human Services and the U.S. Department of Defense for their partnership leading up to today's milestone of EUA request submission."

Novavax and Israel Announce Advance Purchase Agreement for Supply of COVID-19 Vaccine

The Novavax vaccine would be the first protein-based alternative available in Israel

GAITHERSBURG, Md., Jan. 28, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Israel's Ministry of Health today announced an agreement for the purchase of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant.

"Israel has been at the forefront of the fight against COVID-19 and has demonstrated strong leadership throughout the pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank the Israeli Ministry of Health for their commitment to providing a protein-based COVID-19 vaccine option, based on well-understood technology, to the people of Israel."

Under the advance purchase agreement, Novavax will provide an initial 5 million doses of its protein-based vaccine with an option for Israel to purchase an additional 5 million doses. Novavax will work with the Ministry of Health to obtain the necessary authorizations and finalize plans for distribution in Israel pending regulatory approval.

CoapTech Awarded Seed Fund Grant from Pennsylvania Pediatric Device Consortium

BALTIMORE, Jan. 27, 2022 /PRNewswire/ -- CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today it has been awarded a $50,000 grant by the Children's Hospital of Philadelphia-based Pennsylvania Pediatric Medical Device Consortium ("PPDC") for its PUMA-G Peds System, a device designed to provide a safer way to place feeding tubes in children.

The PUMA System™ is a new category of minimally invasive devices, enabling ultrasound procedures in hollow organs of the body where previously it was impossible or unsafe to do so. The PUMA-G Peds System is being developed to allow ultrasound-based placement of gastrostomy tubes in pediatric patients as an alternative to traditional endoscopic or fluoroscopic procedures. Endoscopic procedures cannot "see through" tissue which can result in organ damage or other complications. Fluoroscopic procedures require the use of ionizing radiation which presents long term risk of cancer. The PUMA-G Peds System uses ultrasound to visualize tissue and organs in real time without ionizing radiation. It is designed to operate like the currently available adult PUMA-G System, with modifications to accommodate the pediatric patient population.

Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma :: Immunocore PLC

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, Wednesday, January 26, 2022) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases today announces approval from the United States Food and Drug Administration (FDA) of KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

Looking Back with Pride—and Forward with Purpose

At the University System of Maryland, January brings with it the chance to reflect on a year of accomplishment and anticipate a year of impact. Because, despite the challenges of the past several months, we’re still doing the work we were built to do. Our students are excelling. Our scholarship is making change. Our research is solving problems. Our service is improving lives.

This is a direct credit to the people of the USM. As COVID upended our academic enterprise and administrative operations, our people kept working harder, with a clarity of purpose and a devotion to mission that is, to me, breathtaking. The achievements and ambitions I share here honor their dedication.

Maryland life science & digital health companies drive record VC investment. | Maryland Business News

In 2021, venture capitalists invested $2.27 billion in Maryland companies, according to the initial figures from the PitchBook-NVCA Venture Monitor Report. VC investment in 2021 shattered the record set in 2020 of $1.24 billion, and marks the third consecutive year of record-setting investment in Maryland companies.

Given the high concentration of life sciences and digital health companies located in Maryland, it’s no surprise that investors turned their eyes, and their dollars, here last year. Significant local investments are fueling innovation across nearly every field, from cancer research to healthcare analytics. Below are some themes from Maryland’s banner year in venture capital.

Trends in Talent Acquisition, COVID Edition · BioBuzz

The pandemic, now approaching year three in full force, has impacted nearly every facet of the life sciences’ job market. A talent shortage existed pre-pandemic and has only accelerated since then. For life sciences employers, finding and securing talent will continue to be a major challenge throughout 2022.

5 Cities Emerging As Future Hubs For Life Sciences Development

The current boom in life sciences development mirrors the tech industry, especially geographically; there is an incredible concentration of jobs and investment in the top markets, in this case Boston, San Diego and the Bay Area and challenges finding support and funding anywhere else.

Image: Courtesy of Bill Timmerman A lab at 850 PBC, a Wexford lab development in downtown Phoenix.

Vaccitech CEO Bill Enright Joins Rich Bendis on First BioTalk of 2022

Bill visits BioTalk to talk about being a serial entrepreneur, biotech executive, and their recent acquisition of Avidea Technologies.

Listen now via Apple https://apple.co/3fTySQM, Google https://bit.ly/3KDPMkh, Spotify https://spoti.fi/3rI7UB3, Amazon https://amzn.to/33DwOtH, or TuneIn https://bit.ly/3fS8C9f.