NurOwn is being developed for the treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (PMS) and other neurodegenerative diseases.
Catalent, a biopharma focused CDMO, entered into a partnership with Brainstorm in 2020 to provide CGMP clinical supply of NurOwn, in anticipation of the product candidate's potential regulatory approval.
Chaim Lebovits, CEO, BrainStorm Cell Therapeutics, said the manufacturing of cellular therapies such as NurOwn is complex and requires careful planning and very specific expertise. He acknowledged the progress made to date through the alliance with Catalent, which it noted has industry-leading capabilities in the field.
The NurOwn technology platform - autologous MSC-NTF cells - represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders, according to BrainStorm.
MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo, it explained.
“The MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.”
Cell therapy capabilities
Since 2020, Catalent has invested in its cell therapy capabilities.
Alongside its facility in Texas, it has a site in Maryland, and runs its European Center of Excellence for cell and gene therapy out of its campus in Gosselies, Belgium.
The organization continues to increase its clinical and commercial-scale manufacturing capabilities across the full range of cell and gene therapy activity, with it finalizing a deal to acquire Dusseldorf-based human induced pluripotent stem cells (iPSCs) developer, RheinCell Therapeutics, in August.
John Chiminski, CEO, Catalent, on a conference call with analysts in August, noted that the dynamics in the cell and gene therapy space continue to be extremely robust.
“Over the last two years, we've added critical pieces to our portfolio, in the cell therapy space giving additional manufacturing facilities and capacity, we entered into the plasmid DNA space, and now, obviously, with the acquisition of RheinCell, we have our hands on a kind of iPSC cell bank. So, we really think that we have a strong portfolio.”
The company, he said, has a strong footprint for cell therapy. “And we have a huge capability in viral vector manufacturing in the Baltimore area. But if we were able to get our hands on the right asset from a viral vector manufacturing standpoint in Europe, that would also be a priority for us."