BrainStrom Cell Therapeutics Inc. (NASDAQ:BCLI) has announced an agreement with Catalent (NYSE:CTLT) for the manufacture of its autologous cellular therapy, NurOwn®. BrainStorm’s NurOwn® is being studied to treat amyotrophic lateral sclerosis (ALS), also known as motor neuron disease or Lou Gehrig’s disease.
NurOwn has Fast Track designation for ALS from the FDA
The autologous cellular therapy induces mesenchymal stem cells (MSC) to produce high levels of neurotrophic factors that promote neuroprotection and survival of neurons. The therapy targets disease pathways integral in neurodegenerative disorders. The FDA has granted NurOwn® Fast Track designation for amyotrophic lateral sclerosis, and it has also received Orphan Drug Status from the EMA and FDA for ALS. Currently, BrainStorm is completing a 200-patient placebo-controlled, double-blind repeat-dosing NurOwn in third phase study in the US.
As part of the agreement, Catalent will transfer the manufacturing process to BrainStorm and offer future CGMP clinical supply of NurOwn from the 32,000 sq. ft. cell therapy manufacturing facility in Texas. After completing the clinical trials and ahead of possible approval of NurOwn, the companies will extend the agreement to include commercial supply from the facility.
Catalent to support manufacturing and commercialization of NurOwn
BrainStor’s CEO, Chaim Lebovatis, said that they are proud to enter a partnership with Catalent to support the commercial supply of NurOwn. Lebovits said that there is an urgent need for a new treatment alternative for ALS patients. He added that if the current NurOwn clinical trials are successful, then the agreement with Catalent will be vital in accelerating access for ALS patients.
Manja Boerman, the President of Catalent Cell & Gene therapy, indicated that they have experience in cell therapy development, a capable state-of-the-art facility in Huston to meet manufacturing needs. He added that this will position the company to support BrainStorm in manufacturing its lead therapeutic candidate to treat ALS. Boerman said that they are looking forward to the partnership with BrainStorm and offering their stem cell therapy manufacturing expertise to optimize production and streamline NurOwn’s commercialization path.