BrainStorm Cell Therapeutics and Pluri Collaborate on NurOwn® Phase 3b Trial Production

BrainStorm Cell Therapeutics Inc., listed on NASDAQ as BCLI, has announced a significant development in its fight against neurodegenerative diseases. The company, known for its innovative cellular therapies, has entered into a Memorandum of Understanding (MOU) with Pluri Inc. (NASDAQ: PLUR) via Pluri’s wholly owned subsidiary. This initiative is set to advance the manufacturing of NurOwn®, BrainStorm’s proposed treatment for amyotrophic lateral sclerosis (ALS), in preparation for an impending Phase 3b clinical trial.

The MOU outlines the commencement of technology transfer from BrainStorm to Pluri, allowing for initial production at Pluri’s facilities in Israel. Under the proposed agreement, Pluri will provide Good Manufacturing Practice (GMP)-compliant production of NurOwn, catering to BrainStorm’s clinical trial needs. This partnership could extend to cover future commercial distribution, contingent on regulatory approval.

Haro Hartounian, PhD, BrainStorm’s Chief Operating Officer, emphasized Pluri’s expertise in GMP-compliant manufacturing, which ensures high quality and regulatory adherence. Pluri’s facilities will support BrainStorm’s ongoing clinical activities at The Center for Advanced Cellular Therapies (I-ACT) in Israel, enhancing collaboration and productivity between the two entities.

Chaim Lebovits, President and CEO of BrainStorm, highlighted the strategic importance of this MOU, which aids in meeting the clinical supply demands for NurOwn® and aligns with the company’s broader strategic goals. This step is crucial as BrainStorm prepares for the operational and financial responsibilities of the upcoming Phase 3b trial.

Yaky Yanay, CEO and President of Pluri, expressed enthusiasm for supporting BrainStorm’s mission to develop a novel cell therapy for ALS. He lauded BrainStorm’s dedication to this cause and looked forward to leveraging Pluri’s extensive experience in cell-based product manufacturing.

The designed Phase 3b trial aims to enroll approximately 200 ALS patients, divided into two segments. In Part A, participants will receive three doses of either NurOwn or a placebo over a 24-week period. In the subsequent open-label Part B, all participants will receive three doses of NurOwn over another 24 weeks. The primary endpoint will compare changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) from baseline to week 24 between the NurOwn and placebo groups. Completion of Part A could enable BrainStorm to submit a Biologics License Application (BLA) for regulatory approval, potentially accelerating the market introduction of NurOwn.

BrainStorm has scheduled an investor conference call for later in the fourth quarter of 2024 to provide further updates on the NurOwn Phase 3 clinical program.

NurOwn® utilizes autologous MSC-NTF cells, derived from each ALS patient, to address neurodegenerative pathways via a proprietary manufacturing process. These cells release neurotrophic factors aimed at targeting specific disease mechanisms. BrainStorm has consistently demonstrated its commitment to ALS through rigorous preclinical research and multiple clinical studies published in peer-reviewed journals. Insights from the NurOwn clinical program have shed light on ALS pathology, disease progression, and treatment efficacy. Notable analyses include the Floor Effect quantification and evaluation of multiple biomarkers over the trial period, along with genetic data, marking significant advancements in ALS therapeutic research.

Pluri Inc. is at the forefront of developing cell-based products for various commercial applications, including medical treatments and addressing global challenges such as climate change and food scarcity. Pluri’s state-of-the-art 3D cell expansion system facilitates mass cell production, making it a critical partner for companies from early preclinical development through to clinical trials and commercialization.

BrainStorm Cell Therapeutics Inc. continues to lead in developing stem cell therapeutics for debilitating neurodegenerative conditions. Through its exclusive global licensing agreement, BrainStorm holds the rights to the NurOwn® technology platform, which has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for ALS treatment. The company has completed a Phase 3 ALS trial and is engaged in further research to enhance its therapeutic strategies.

This collaboration between BrainStorm and Pluri marks a pivotal advancement in the quest to bring effective treatments to ALS patients, embodying hope and scientific progress.