Memorandum of Understanding has been signed NEW 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 tria.