BrainStorm: BrainStorm Cell Therapeutics and Pluri Partner to Support NurOwn Phase 3b Trial Manufacturing

Memorandum of Understanding has been signedNEW YORK, Nov. 11, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that it has entered into a Memorandum of Understanding (MOU) with Pluri Inc. (NASDAQ:PLUR) through its wholly owned subsidiary ("Pluri"), an established global leader in the development and manufacturing of cell-based therapeutics, to manufacture NurOwn® for use in BrainStorm's planned Phase 3b trial in amyotrophic lateral sclerosis (ALS). This MOU enables BrainStorm to begin transfer of its manufacturing technology and start producing NurOwn at Pluri's manufacturing facility upon finalizing the binding definitive agreement.Under the terms of the proposed agreement, Pluri will provide GMP-compliant manufacturing of NurOwn at its facilities in Israel. This collaboration aims to fulfill essential supply requirements of NurOwn® as BrainStorm advances its Phase 3b clinical trial. Additionally, the two companies are exploring options for manufacturing to support potential future commercial distribution, pending approval of NurOwn."Pluri has become a recognized leader in GMP-compliant clinical manufacturing of cell-based products, known for their exceptional quality standards and strict regulatory compliance," said Haro Hartounian, PhD, Chief Operating Officer at BrainStorm. "Pluri will offer manufacturing capacity to support our Phase 3b clinical trials, in addition to our existing development and clinical manufacturing activities at The Center for Advanced Cellular Therapies (I-ACT) in Israel. We believe that having Pluri's clinical manufacturing facility near BrainStorm's manufacturing and R&D teams will strengthen communication and foster a highly productive collaboration."Chaim Lebovits, President and CEO of Brainstorm, added, "The Phase 3b clinical trial marks a critical step toward potential regulatory approval of NurOwn, "This MOU with Pluri creates a strong foundation to meet the clinical supply requirements of NurOwn®. The proposed agreement also offers the prospect of establishing an attractive supply arrangement that aligns well with our strategic priorities as we prepare for the operational and financial commitments of the Phase 3b trial."Yaky Yanay, CEO and President of Pluri commented, "We applaud BrainStorm for their commitment to developing a novel cell therapy for ALS. We are eager to utilize our proprietary knowledge, long years of experience and manufacturing capabilities to support their mission of bringing hope to patients and families impacted by this devastating disease."The Phase 3b trial has been designed to enroll up to approximately 200 participants with ALS. It will be conducted in two ...Full story available on Benzinga.com