BrainStorm teams with Minaris to manufacture neuro cell therapy for Phase 3b ALS trial

BrainStorm Cell Therapeutics has signed a letter of intent with Minaris Advanced Therapies to manufacture NurOwn, its investigational stem cell-based therapy for amyotrophic lateral sclerosis (ALS), ahead of its upcoming Phase 3b clinical trial in the U.S.

The agreement initiates a technology transfer process to Minaris’ GMP facility in Allendale, New Jersey, supporting BrainStorm’s readiness for trial execution.

Minaris, a CDMO specializing in cell and gene therapies, will apply its cell therapy manufacturing capabilities to support NurOwn production at clinical scale. The collaboration aims to ensure compliance with regulatory standards and enable a seamless transition toward potential commercial manufacturing.

The agreement follows BrainStorm’s recent partnership with Pluri Inc. to support additional clinical material production in Israel, reinforcing the company’s dual-continent manufacturing strategy.

NurOwn is BrainStorm’s lead autologous stem cell platform targeting neurodegenerative diseases. The therapy is produced from patients’ own bone marrow-derived mesenchymal stem cells, which are expanded and differentiated under proprietary conditions to secrete neurotrophic factors.

Designed to modulate inflammation and protect neurons, NurOwn has previously completed a Phase 3 trial and will enter a new Phase 3b study under a Special Protocol Assessment agreement with the FDA.

According to BrainStorm CEO Chaim Lebovits, the Minaris partnership reflects the company’s commitment to the ALS community and strengthens its manufacturing network ahead of future commercialization. The Phase 3b trial will evaluate NurOwn in a multicenter U.S. study and aims to build on previous clinical and biomarker findings.