BrainStorm Cell Therapeutics, a leading developer of adult stem cell therapies for neurodegenerative diseases, announced that it has signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to manufacture NurOwn for its upcoming clinical trial.
The LOI marks the beginning of a strategic collaboration between BrainStorm and Minaris to initiate the technology transfer of NurOwn in preparation for clinical trial manufacturing at Minaris’ state-of-the-art facility in Allendale, New Jersey. This partnership supports BrainStorm’s readiness for its planned Phase 3b clinical trial.
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“We are excited to support BrainStorm in the next phase of NurOwn development,” said Eytan Abraham, Ph.D., Chief Commercial and Technology Officer at Minaris Advanced Therapies. “Our team looks forward to applying our expertise in cell therapy manufacturing to enable BrainStorm to conduct its clinical trial to the highest standards and move efficiently to commercial manufacturing.”
This partnership enhances BrainStorm’s U.S. based manufacturing capabilities and supports its multicenter Phase 3b clinical trial in the United States. It complements BrainStorm’s recently announced collaboration with Pluri Inc. in Israel, which will also contribute to the production of clinical trial material. Together, these strategic relationships reinforce BrainStorm’s commitment to building a robust and flexible manufacturing network to advance the clinical development of NurOwn.
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Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics, commented, “This partnership reflects our ongoing commitment to the ALS community and to advancing a therapy with the potential to meaningfully impact patients‘ lives. NurOwn represents a scientifically advanced and differentiated approach to treating ALS, and by joining forces with Minaris Advanced Therapies, we are ensuring that our clinical and manufacturing strategies are tightly aligned to support a successful Phase 3b trial and beyond,”
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Source – PR Newswire