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BrainStorm and Minaris: A New Era for ALS Clinical Trials

On May 27, 2025, BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), renowned for its work in developing adult stem cell therapies aimed at progressive neurodegenerative diseases, revealed a pivotal partnership with Minaris Advanced Therapies. This partnership comes as BrainStorm gears up for its anticipated Phase 3b clinical trials for its innovative therapy, NurOwn®, targeted at amyotrophic lateral sclerosis (ALS).

The Significance of the Partnership

The signing of the Letter of Intent (LOI) between BrainStorm and Minaris marks the initiation of a strategic alliance aimed at enhancing the technology transfer process of NurOwn®. This collaboration is set to take off at Minaris' cutting-edge manufacturing facility located in Allendale, New Jersey. By leveraging Minaris’ advanced capabilities in cell and gene therapies, the partnership aims to ensure BrainStorm is perfectly positioned for its upcoming clinical trials, which are critical for ALS patients.
Eytan Abraham, Ph.D., Chief Commercial and Technology Officer at Minaris, expressed optimism regarding the collaboration, stating, "We are excited to support BrainStorm in the next phase of NurOwn development." Notably, this partnership is designed to maintain high standards in clinical trial manufacturing and prepares them for a direct transition into commercial production.

Enhancing Manufacturing Capabilities

The partnership significantly strengthens BrainStorm's U.S.-based manufacturing landscape, a crucial requirement for the multicenter Phase 3b clinical trial set to launch in the United States. This collaboration dovetails with BrainStorm’s recent engagement with Pluri Inc. (Nasdaq: PLUR) in Israel, both endeavors aimed at ensuring a robust product supply as they advance their clinical efforts.
Chaim Lebovits, President and CEO of BrainStorm, shared his thoughts on this strategic collaboration, emphasizing the company's commitment to the ALS community. He stated, "This partnership reflects our ongoing commitment to the ALS community and to advancing a therapy with the potential to meaningfully impact patients' lives." He added that by working with Minaris Advanced Therapies, BrainStorm is aligning its clinical and manufacturing strategies for a successful Phase 3b trial.

Understanding NurOwn® and Its Potential

The NurOwn® platform utilizes autologous mesenchymal stem cells (MSCs) derived from the patient's own bone marrow. These cells are engineered to produce neurotrophic factor-secreting cells (MSC-NTF cells) aimed at targeting critical disease pathways related to neurodegenerative disorders. The promise of this investigational therapy lies in its ability to deliver multiple neurotrophic factors and immunomodulatory cytokines directly to damaged areas, potentially slowing, stabilizing, or even reversing the progression of ALS.
BrainStorm's therapies are not new to the ALS community, having already been granted Orphan Drug designation by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The successful completion of a Phase 3 clinical trial has laid a strong foundation for the upcoming trials under a Special Protocol Assessment (SPA) agreement with the FDA. This trial aims at generating further insights into ALS disease biology and measuring key clinical outcomes.

The Road Ahead

As BrainStorm navigates this pivotal stage in its clinical development, it continues to forge forward with plans for a robust pipeline and further research into other conditions, including progressive multiple sclerosis (MS). The recent strength of their intellectual property portfolio, particularly following the acquisition of a foundational patent for exosome technology, further enhances their capabilities in regenerative medicine.
In conclusion, this new partnership between BrainStorm and Minaris not only paves the way for essential advancements in ALS treatment but also reflects the broader potential for collaboration within the biotechnology ecosystem. The commitment to innovate and serve the ALS community remains paramount for BrainStorm, promising hope for patients and their families.

Conclusion

With looming clinical trials and a strong manufacturing partnership, the future is looking brighter for BrainStorm Cell Therapeutics and the patients they aim to serve. As they embark on this journey with Minaris, the expectations are high, and the stakes even higher. Their work signifies a crucial advancement in the ongoing quest for effective treatments for ALS and potentially other debilitating neurodegenerative diseases.