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Andy

ArecellxKite

Arcellx and Kite Announce Expansion in Strategic Partnership

By News

ArecellxKite— Arcellx to receive $200M equity investment at $61.68 per share and an $85 million upfront cash payment —

— Kite exercises option to Arcellx’s ARC-SparX program ACLX-001 in multiple myeloma —

— The companies expand the scope of their existing collaboration for CART-ddBCMA to include lymphomas —

REDWOOD CITY, Calif. and SANTA MONICA, Calif.Nov. 15, 2023 /PRNewswire/ — Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced that the companies have expanded their existing collaboration, which was originally announced in December 2022.

Kite has exercised its option to negotiate a license for Arcellx’s ARC-SparX program, ACLX-001, in multiple myeloma, which is comprised of ARC-T cells and SparX proteins that target BCMA. The companies have also expanded the scope of the collaboration for Arcellx’s CART-ddBCMA to include lymphomas.   

“Since entering into this strategic collaboration with Kite almost one year ago, we are thrilled with how the partnership is rapidly progressing and the alignment across our teams,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “Helping as many cancer patients as possible serves as the core of our collaboration. With the deep and durable responses demonstrated in our CART-ddBCMA Phase 1 trial in multiple myeloma, we believe that our novel synthetic binder, the D-Domain, underscores the potential to engineer a new class of CAR T therapies. We are excited to deepen our relationship with Kite as they continue to invest in our platform by exercising their rights to our ACLX-001 ARC-SparX program in multiple myeloma and increasing their investment in our company. With this additional investment from Kite, our strengthened cash position is anticipated to extend our runway into 2027, as we advance towards commercializing CART-ddBCMA. Additionally, as our partnership deepens, we continue to identify operational efficiencies and additional opportunities to collaborate which are also reflected in this agreement. Importantly, these efficiencies embody the trust developed with our Kite partners and do not alter the original agreement in principle or economics. We look forward to sharing data from our CART-ddBCMA Phase 1 trial at ASH in December.”

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ReveraGenlogo

BizJournals – Children’s National Hospital spinout ReveraGen BioPharma gearing up for muscular dystrophy drug launch

By News

Rockville’s ReveraGen BioPharma Inc., a 15-year-old Children’s National Hospital spinout, is preparing for the launch of its neuromuscular disease drug — and sees an opportunity to advance it for other conditions.

ReveraGen scored the Food and Drug Administration’s approval in late October for its treatment for Duchenne muscular dystrophy, or DMD, the most common and severe type of muscular dystrophy that plagues young boys with progressive muscle weakness and atrophy.

The therapy, called vamorolone, has anti-inflammatory properties similar to traditional corticosteroids such as prednisone — but without typical complications such as weakened bones and stunted growth.

For decades, the market has lacked a steroid “that’s able to keep the benefit, but mitigate some of the side effects,” said Eric Hoffman, president and CEO of ReveraGen.

The drug showed in clinical trials to improve muscle strength and stature in DMD patients, and otherwise was comparable in its effects to corticosteroids, the standard of care for DMD. It’ll be sold starting in 2024 under the brand name Agamree by Coral Gables, Florida-based Catalyst Pharma Inc., via a sublicensing deal with Switzerland’s Santhera Pharmaceuticals.

 

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Childrens

Children’s National Hospital selected as member of ARPA-H Investor Catalyst Hub spoke network

By News

The hospital will advocate for the unique needs of children as part of nationwide network working to accelerate transformative health solutions

November 13, 2023 – ChildrensChildren’s National Hospital was selected as a spoke for the Investor Catalyst Hub, a regional hub of ARPANET-H, a nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H).

The Investor Catalyst Hub seeks to accelerate the commercialization of groundbreaking and accessible biomedical solutions. It uses an innovative hub-and-spoke model designed to reach a wide range of nonprofit organizations and Minority-Serving Institutions, with the aim of delivering scalable healthcare outcomes for all Americans.

“The needs of children often differ significantly from those of adults. This partnership reflects our commitment to advancing pediatric healthcare through innovation and making sure we’re addressing those needs effectively,” said Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National. “Leveraging the strength of this hub-and-spoke model, we anticipate delivering transformative solutions to enhance the health and well-being of the patients and families we serve.”

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Selecta

Selecta Biosciences Announces Merger with Cartesian Therapeutics

By News

SelectaWATERTOWN, Mass. and GAITHERSBURG, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) — Selecta Biosciences, Inc. (NASDAQ: SELB) (the Company) today announced that it has merged with Cartesian Therapeutics, Inc., a clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases. In connection with the merger, Selecta announced a $60.25 million private financing led by Timothy A. Springer, Ph.D., member of the Selecta Board of Directors.

With the cash from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have over $110 million on hand to support the development of the Cartesian pipeline through the Phase 3 study of lead product candidate, Descartes-08, a potential first-in-class RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T) for the treatment of MG, as well as the advancement of additional RNA cell therapy programs.

Concurrent with the merger, the combined company has been renamed Cartesian Therapeutics, Inc. The Company’s Nasdaq ticker symbol will change to “RNAC” effective prior to the opening of trading tomorrow, November 14, 2023.

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Michael and Rich 250 x 500 px

BioTalk – Driving Cancer Research Innovation: A Conversation with Michael Weingarten, Director, SBIR Development Center at the National Cancer Institute (NCI)

By News

Michael and Rich 250 x 500 pxWhat are the latest advancements in cancer research and innovation? Join us in this episode of BioTalk with Rich Bendis as we explore the dynamic world of cancer research and technology development with our distinguished guest, Michael Weingarten, Director of the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI).

Mr. Weingarten plays a pivotal role in leading a team of Program Directors managing the NCI’s SBIR & STTR Programs, overseeing a substantial portfolio of $182 million in grants and contracts annually. These programs are at the forefront of NCI’s efforts to drive innovation, fostering the development and commercialization of groundbreaking technologies and products for cancer prevention, diagnosis, and treatment.

Listen now via your favorite podcasting platform:

Explore the intersection of the BioHealth Capital Region and the NCI, understanding how collaboration and partnerships are shaping the future of cancer research and innovation. Michael and Rich delve into the goals for the future, highlighting the NCI’s vision and commitment to advancing cancer prevention, diagnosis, and treatment through technology and innovation.

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Michael and Rich 250 x 500 px

BioTalk – Driving Cancer Research Innovation: A Conversation with Michael Weingarten, Director, SBIR Development Center at the National Cancer Institute (NCI)

By BioTalk with Rich Bendis Podcast

Michael and Rich 250 x 500 pxWhat are the latest advancements in cancer research and innovation? Join us in this episode of BioTalk with Rich Bendis as we explore the dynamic world of cancer research and technology development with our distinguished guest, Michael Weingarten, Director of the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI).

Mr. Weingarten plays a pivotal role in leading a team of Program Directors managing the NCI’s SBIR & STTR Programs, overseeing a substantial portfolio of $182 million in grants and contracts annually. These programs are at the forefront of NCI’s efforts to drive innovation, fostering the development and commercialization of groundbreaking technologies and products for cancer prevention, diagnosis, and treatment.

Listen now via your favorite podcasting platform:

Explore the intersection of the BioHealth Capital Region and the NCI, understanding how collaboration and partnerships are shaping the future of cancer research and innovation. Michael and Rich delve into the goals for the future, highlighting the NCI’s vision and commitment to advancing cancer prevention, diagnosis, and treatment through technology and innovation.

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BHIBoard

BioHealth Innovation, Inc. Welcomes Dr. Eric S. Edwards of Phlow Corporation to the Board of Directors and Appoints Donna J. Edmonds of BRAINBox Solutions, Inc. as Vice Chair

By News

BHIBoardROCKVILLE, MARYLAND, November 13, 2023 BioHealth Innovation, Inc. (BHI), a leading organization dedicated to supporting and advancing the BioHealth industry, is pleased to announce the appointment of Dr. Eric S. Edwards, Co-founder and CEO of Phlow Corporation, to its Board of Directors. In addition, Donna J. Edmonds, CEO of BRAINBox Solutions, Inc., has been appointed as the new Vice Chair of the Board.

“We are incredibly excited to welcome Dr. Eric S. Edwards to our Board of Directors and to appoint Donna J. Edmonds as our new Vice Chair,” said Richard Bendis, BHI President and CEO. “Dr. Edwards’ remarkable achievements in pharmaceutical innovation and his dedication to improving healthcare delivery are perfectly aligned with our mission at BHI. Similarly, Donna’s extensive experience and proven leadership in the healthcare sector will be invaluable as we continue to drive forward our vision. Their appointments signify BHI’s continued journey towards fostering a robust and dynamic BioHealth ecosystem in our region.”

Dr. Eric S. Edwards, currently the Co-founder and CEO of Phlow Corporation, brings a wealth of experience and innovation to BioHealth Innovation, Inc. (BHI). With a remarkable career spanning pharmaceuticals and healthcare, Dr. Edwards is at the forefront of securing the supply chain for critical essential medicines in America. His visionary leadership extends beyond Phlow, as he co-founded Kaléo, Inc., a pharmaceutical company dedicated to novel treatments for chronic and acute-care diseases.

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NHLBI

The NHLBI is accepting applications for the I-Corps at NIH™ Program

By News

NHLBIThe NHLBI is accepting applications for the I-Corps at NIH™ Program, which provides funding, mentoring, and networking opportunities to current Phase I SBIR/STTR awardees and Fast-Track awardees in the first phase of their award to help commercialize your promising biomedical technology. During this 8-week, hands-on program, you’ll learn how to focus your business plan and get the tools to bring your treatment to the patients who need it most.   

Program benefits include:   

  • Funding up to $55,000 to cover total program costs  
  • Training from biotech sector experts  
  • Expanding your professional network 
  • Building the confidence and skills to create a comprehensive business model  
  • Gaining years of entrepreneurial skills in a matter of week

All applications must be submitted through PAR-22-073 no later than November 15, 2023. Please note that the updated due dates for the FY2024 I-Corps at NIH™ cohorts may be found at NOT-OD-23-188. This cohort begins in March 2024. The sessions will be held virtually except for the in-person kickoff in Houston, TX, and the in-person closeout session in Bethesda, MD.

 For more information, contact Stephanie Davis, Small Business Program Coordinator (nhlbi_sbir@mail.nih.gov) or visit the I-Corps at NIH™ program website.  

VLP250

VLP Therapeutics group announces 3rd closing of funding to develop cancer, infectious disease vaccines; establish investigational vaccine manufacturing facility

By News

VLP250US-based biotech company VLP Therapeutics, Inc. (VLPT) and its Tokyo-based group company VLP Therapeutics Japan, Inc. (VLPT Japan) together announced on November 8 the third closing of its financing round, which secured investments from Sumitomo Mitsui Trust Bank, Limited, a new investor headquartered in Tokyo, and Mr. Robert G. Hisaoka, an existing investor in the US.

With this funding the VLPT group plans to: 1) bolster its vaccine research and development underway in the US for cancer treatment and infectious disease prevention, such as malaria and dengue; and 2) establish a manufacturing facility, which is expected to begin operation in 2024–2025 and will enable VLPT Japan to produce investigational vaccines in-house in Fukuoka, Japan.

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Emergent250

Emergent BioSolutions Submits Supplemental Biologics License Application Seeking U.S. FDA Approval of ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) for Immunization Against Mpox

By News

Emergent250GAITHERSBURG, Md., November 7, 2023 – Emergent (NYSE: EBS) has recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for the expansion of the indication for ACAM2000®, Smallpox (Vaccinia) Vaccine, Live to include immunization against mpox virus. The sBLA includes data from a well-controlled animal study in which ACAM2000® vaccine has been shown to be effective in protecting against mpox virus exposure.

“Community transmission of mpox continues to be a public health challenge in the U.S.,” said Paul Williams, SVP and Products Business Head, Emergent BioSolutions. “Our sBLA submission for ACAM2000® reflects Emergent’s commitment to expanding our product capabilities and continuously support the U.S. government as we address emerging infectious diseases and strengthen future preparedness.”

Mpox, formerly called monkeypox, is a rare disease caused by infection with the mpox virus. Mpox virus is part of the same family of viruses as variola virus, the virus that causes smallpox. Mpox symptoms are similar to smallpox symptoms, but milder, and mpox is rarely fatal.1 Since the start of last year, there have been more than 31,000 mpox cases in the U.S. and 55 deaths, according to the CDC, with more than 91,000 cases and 166 confirmed deaths globally.

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