- BrainStorm Cell Therapeutics partners with Pluri Inc. for Phase 3b clinical trial manufacturing.
- The collaboration will support the production of NurOwn for amyotrophic lateral sclerosis (ALS) treatment, with potential future commercial plans.
BrainStorm Cell Therapeutics Inc. announced a partnership with Pluri Inc. to support the manufacturing of its NurOwn cellular therapy for an upcoming Phase 3b trial targeting amyotrophic lateral sclerosis (ALS). The agreement, established through a Memorandum of Understanding (MOU), allows BrainStorm to transfer its technology to Pluri’s Israel-based facilities and begin production upon finalizing a binding contract.
The collaboration will enable GMP-compliant manufacturing of NurOwn at Pluri’s facility, helping BrainStorm meet supply requirements as it progresses with the 200-participant trial. The companies are also considering future manufacturing to support potential commercial distribution, depending on NurOwn’s regulatory approval.
“Pluri will offer manufacturing capacity to support our Phase 3b clinical trials, in addition to our existing activities at The Center for Advanced Cellular Therapies in Israel,” said Haro Hartounian, PhD, COO of BrainStorm. He added that proximity to BrainStorm’s research teams will enhance collaboration and communication.
The trial, planned to begin in late 2024, will include a 24-week placebo-controlled phase, followed by an open-label period. A successful Phase 3b completion could allow BrainStorm to submit a Biologics License Application (BLA), potentially accelerating NurOwn’s path to market.
Overview of outsourcing trends 
