Update
$Brainstorm Cell Therapeutics (BCLI.US)$ BrainStorm Cell Therapeutics and Pluri Partner to Support NurOwn Phase 3b Trial Manufacturing
PR Newswire· 3 mins ago
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 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."
PR Newswire· 3 mins ago
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 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."
Disclaimer: Community is offered by Moomoo Technologies Inc. and is for educational purposes only.
Read more
Comment
Sign in to post a comment
