BioHealth Innovation Weekly for November 21, 2023

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November 21, 2023

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Breaking Barriers in Enteral Nutrition: Luminoah's Innovative MedTech with Neal Piper on BioTalk

Are you ready to explore the transformative world of MedTech and its profound impact on healthcare? Join us in this episode of BioTalk with Rich Bendis as we dive deep into medical technology with an exceptional guest, Neal Piper, Founder & CEO of Luminoah, winner of the 8th Annual BioHealth Capital Region Crab Trap. Neal Piper is the visionary behind Luminoah, a cutting-edge MedTech company dedicated to enhancing the lives of enteral nutrition patients through innovative hardware and software systems. With a background steeped in healthcare, Neal's journey from Pfizer's Neuroscience Division to his role as President of the Global Health Fellows Alumni Business Network has uniquely positioned him to drive change in the industry. But what inspired Neal to create Luminoah? In 2019, his family received a cancer diagnosis for their 3-year-old son, leading to a new reality and a pressing need for a better nutritional feeding program. Neal recognized the challenges faced by patients and caregivers, from bulky equipment to limited data sharing with physicians. That's when Luminoah was born.

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Arcellx and Kite Announce Expansion in Strategic Partnership

-- 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."

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

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.

MaxCyte Joins the Alliance for mRNA Medicines (AMM) as a Founding Member

MaxCyte continues supporting the advancement of novel therapeutics and looks to support education and advancement of mRNA medicines

ROCKVILLE, Md., Nov. 16, 2023 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, today announced that it has joined the Alliance for mRNA Medicines (AMM), as a founding member. AMM is the leading global organization dedicated to advancing and advocating for mRNA and next-generation encoding RNA therapeutics and vaccines for the benefit of patients, public health and society. AMM’s mission is to propel the future of mRNA medicines, improve patients’ lives, and advance scientific knowledge by convening and empowering mRNA industry leaders, innovators, scientists and other key stakeholders. MaxCyte is one of 31 founding members comprised of biotechnology, biopharma and life sciences companies and educational institutions.

Selecta Biosciences Announces Merger with Cartesian Therapeutics

WATERTOWN, 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.

President Biden Intends to Appoint Dr. W. Kimryn Rathmell as Director of the National Cancer Institute

Today, President Joe Biden announced his intent to appoint Dr. W. Kimryn Rathmell as the 17^th Director of the National Cancer Institute (NCI), the federal government’s principal agency for cancer research and training and the largest funder of cancer research in the world. Dr. W. Kimryn Rathmell is an accomplished physician-scientist and internationally recognized cancer expert who is well suited to lead the NCI during this critical time to achieve the goals the President set for the Biden Cancer Moonshot as part of his Unity Agenda.

Statement from President Biden: “Dr. Rathmell is the talented and visionary leader the National Cancer Institute needs to drive us toward ending cancer as we know it. Throughout her career, she has been committed to advancing discovery through scientific research, maintaining a steadfast commitment to caring for her patients, and demonstrating leadership in preparing the next generation of researchers. She embodies the promise of the Biden Cancer Moonshot and has spent her career driving toward the goals Jill and I set for the initiative, to improve outcomes and boost support for those facing a cancer diagnosis. The National Cancer Institute is central to the success of the Cancer Moonshot and Dr. Rathmell will lead the agency towards new ways to prevent, detect, and treat cancer and to ensure we reach more Americans with the tools we have to save and extend lives.”