Production Partnership for NurOwn in Phase 3b ALS Trial

In a bold stride towards combating Amyotrophic Lateral Sclerosis (ALS), Brainstorm Cell Therapeutics has formed a strategic alliance with Minaris Advanced Therapies. Together, they aim to ramp up the manufacture of NurOwn (debamestrocel), an innovative cell therapy under development for ALS patients. This partnership is a decisive move to expedite the production of NurOwn, thereby setting the stage for an impending Phase 3b clinical trial (NCT06973629).

The crux of this union lies in Minaris’s expertise in cell and gene therapies, a skill set that will be instrumental in developing a robust and flexible manufacturing network for NurOwn. This high-tech network will be established at Minaris’s state-of-the-art facility in Allendale, New Jersey. With the added support from Pluri in Israel, the network will truly be global, optimizing production capabilities.

NurOwn is an avant-garde therapeutic approach that harnesses the potential of the patient’s own mesenchymal stem cells. These self-renewing cells, capable of morphing into varied cell types, are harvested and cultivated into cells that produce neurotrophic factors. These factors play a crucial role in maintaining nerve cell health and survival. The mature cells are then introduced into the fluid surrounding the spinal cord, where they are expected to secrete high levels of neurotrophic factors to combat neurodegeneration, potentially decelerating the progression of ALS.

Brainstorm’s commitment to the ALS community is underscored by this partnership. While NurOwn has produced mixed efficacy in previous clinical trials, the therapy demonstrated a tendency to slow functional decline, particularly for patients with rapidly progressing disease, in a Phase 2a study (NCT02017912). This alliance with Minaris, therefore, is not just a testament to the potential of NurOwn, but also a beacon of hope for ALS patients seeking innovative treatment options.

“This partnership reflects our ongoing commitment to the ALS community and to advancing a therapy with the potential to meaningfully impact patients’ lives,” reaffirmed Chaim Lebovits, Brainstorm’s president and CEO, in a company press release.

As the biotech industry continues to push the boundaries of innovation, collaborations such as these underscore the potential of combining specialized expertise to tackle complex health issues. In the face of a disorder like ALS, which has long eluded effective treatment, the partnership between Brainstorm and Minaris represents a promising pivot towards a brighter, healthier future. With NurOwn at the forefront, Brainstorm and Minaris are poised to redefine ALS therapy, thereby offering a lifeline to those grappling with this crippling disease.

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