US-based biotechnology company BrainStorm Cell Therapeutics has partnered with contract development and manufacturing organisation (CDMO) Minaris Advanced Therapies for the production of the NurOwn technology platform for an upcoming clinical trial.
The partnership will aid in the transfer of technology to prepare for the manufacture of NurOwn at Minaris’ facility in Allendale, New Jersey, US.
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This will expand BrainStorm’s domestic manufacturing capabilities ahead of its planned Phase IIIb trial for treating amyotrophic lateral sclerosis (ALS).
The US Food and Drug Administration (FDA) recently granted clearance to BrainStorm Cell Therapeutics for this trial.
NurOwn represents an investigational therapeutic approach to treating neurodegenerative conditions using autologous MSC-NTF cells.
The platform has secured orphan drug designation from the European Medicines Agency (EMA) and the US FDA for treating ALS.
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By GlobalDataMinaris Advanced Therapies’ chief commercial and technology officer Eytan Abraham said: “We are excited to support BrainStorm in the next phase of NurOwn development.
“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.”
BrainStorm Cell Therapeutics CEO and president Chaim Lebovits said: “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 IIIb trial and beyond.”
The agreement comes after BrainStorm’s recent partnership with Israeli biotechnology company Pluri, which is also producing material for the Phase IIIb trial.
BrainStorm said these partnerships are part of its efforts to create a robust, flexible manufacturing network for NurOwn’s clinical development.
