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PluriCDMO will manufacture AstroRx for the treatment of ALS for an upcoming Phase 2a study, and IsletRx for the treatment of diabetes.
July 18, 2024
By: Kristin Brooks
Managing Editor, Contract Pharma
Pluri Inc., a biotechnology company, 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. GMP cell production facility to manufacture cell-based products for life science companies.
PluriCDMO will manufacture two cell therapy 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.
PluriCDMO offers experience in developing and manufacturing cell-based products in GMP grade for clinical use, from initial clinical trial batches to mass scale commercial production.
“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,” said 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.”
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