Pluri’s CDMO Selected to Manufacture Kadimastem’s Novel Cell Therapy Product Candidates

Pluri Inc. recently announced it has signed a tech transfer and manufacturing agreement with Kadimastem Ltd., a clinical stage biotechnology company developing therapeutic cells for ALS and diabetes treatments. PluriCDMO, launched earlier this year, leverages Pluri’s 47,000-sq-ft good manufacturing practice (GMP) cell production facility to manufacture cell-based products for life science companies.

PluriCDMO will manufacture two cell therapy product candidates for Kadimastem: AstroRx, clinical-grade human astrocytes (nervous system supporting cells) for the treatment of ALS for an upcoming U.S. FDA Phase 2a study; and IsletRx, clinical grade pancreatic islet cells which produce and secrete insulin and glucagon in response to blood glucose levels, for the treatment of diabetes.

Key to Kadimastem’s selection of PluriCDMO is Pluri’s unparalleled expertise and experience in developing and manufacturing cell-based products in GMP grade for clinical use. From initial clinical trial batches to mass scale commercial production, PluriCDMO is a long-term partner and service provider for the cell therapy production needs of the most innovative companies.

“Working with Pluri marks a pivotal milestone, enhancing Kadimastem’s capacity to manufacture our products under GMP conditions,” said Ronen Twito, Executive Chairman & President of Kadimastem, “This collaboration is integral to our strategy as we prepare for clinical trials and expand into the US market with our AstroRx® product candidate.”

“We are excited to work with Kadimastem and support their development of cell therapies, potentially improving the lives of patients with ALS and diabetes,” added Yaky Yanay, Chief Executive Officer and President of Pluri. “This collaboration underscores the versatility of our PluriCDMO platform and our commitment to aiding innovative companies in advancing their life-saving therapies. We look forward to a successful collaboration with Kadimastem as they progress their clinical development programs.”

Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, foodtech and agtech. The company also offers CDMO services. Pluri establishes partnerships that leverage the company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. For more information, visit www.pluri-biotech.com.

Pluri launched its CDMO division in January 2024, leveraging its proprietary knowledge, cutting-edge technology and cell therapy production facility on behalf of clients. PluriCDMO clients gain access to Pluri’s state-of-the-art GMP facilities, and to Pluri’s patented bioreactor system, which enables 3D cell expansion at mass scale via a fully controlled, automated and validated process. For more information, visit https://pluri-biotech.com/transforming-cell-therapy/ or contact CDMO@Pluri-biotech.com.

Kadimastem is a clinical stage cell therapy company, developing “off-the-shelf”, allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx, healthy and functional human astrocytes, is the company’s lead product in clinical development for the treatment for ALS and in pre-clinical development stage for other neurodegenerative indications. IsletRx is the company’s treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).