Manufacturing collaboration clinched by BrainStorm with Minaris for upcoming Phase 3b trials of NurOwn® in ALS
BrainStorm Cell Therapeutics Inc., a leading developer of autologous adult stem cell therapies for neurodegenerative diseases, has taken a significant step forward in its mission to bring innovative treatments to patients with debilitating conditions. The company has announced a strategic partnership with Minaris Advanced Therapies, focusing on the manufacturing of BrainStorm's lead investigational therapy, NurOwn®, for clinical trials targeting amyotrophic lateral sclerosis (ALS).
Under the terms of the partnership, BrainStorm has signed a Letter of Intent (LOI) with Minaris Advanced Therapies to manufacture NurOwn® in the U.S. for the upcoming Phase 3b clinical trial of NurOwn® in ALS patients. This collaboration will complement BrainStorm's existing manufacturing network, which includes a partnership with Pluri Inc. in Israel, thereby establishing robust production capabilities to support the clinical development of NurOwn® on a multicenter, international scale.
The Phase 3b trial, designed under a Special Protocol Assessment (SPA) agreement with the FDA, will enroll approximately 200 early-stage ALS patients across 15 clinical sites in a 24-week randomized, double-blind, placebo-controlled study, followed by a 24-week open-label extension where all patients receive NurOwn®. The partnership aims to ensure high-quality, scalable manufacturing of NurOwn® to meet the demands of this pivotal clinical trial and anticipates readiness for eventual commercialization if the trial results are favorable.
Eytan Abraham, Ph.D., Chief Commercial and Technology Officer at Minaris Advanced Therapies, expressed his excitement about supporting BrainStorm in the next phase of NurOwn development. Chaim Lebovits, President and Chief Executive Officer of BrainStorm Cell Therapeutics, commented on the partnership, reflecting BrainStorm's commitment to the ALS community and advancing a therapy with the potential to meaningfully impact patients' lives.
NurOwn technology platform uses autologous MSC-NTF cells, which are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. These cells are designed to effectively deliver multiple neurotrophic factors (NTFs) and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.
The strategic partnership between BrainStorm and Minaris is a foundational step to support the rigorous Phase 3b clinical evaluation of NurOwn® for ALS, providing U.S.-based manufacturing capacity integral to advancing the therapy toward potential market approval. BrainStorm has already published its findings regarding the NurOwn clinical program in multiple peer-reviewed journals, and the technology platform has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
This manufacturing arrangement is a key strategic move given BrainStorm’s financial constraints and the importance of the Phase 3b study as a critical milestone for NurOwn®'s regulatory approval prospects. With this partnership, BrainStorm is well-positioned to bring its promising therapy to ALS patients in need.
[1] BrainStorm Cell Therapeutics Inc. (2023). BrainStorm Cell Therapeutics Announces Manufacturing Agreement with Minaris Advanced Therapies for U.S. Manufacturing of NurOwn® for Upcoming Phase 3b Clinical Trial in ALS. [Press release]. Retrieved from https://www.brainstorm-cell.com/news-and-events/press-releases
[2] Minaris Advanced Therapies (2023). BrainStorm Cell Therapeutics and Minaris Advanced Therapies Announce Strategic Partnership to Manufacture NurOwn® for Clinical Trials in ALS. [Press release]. Retrieved from https://www.minaris-at.com/news-and-media/press-releases/brainstorm-cell-therapeutics-and-minaris-advanced-therapies-announce-strategic-partnership-to-manufacture-nurown-for-clinical-trials-in-als
[4] BrainStorm Cell Therapeutics Inc. (2023). BrainStorm Announces Manufacturing Agreement with Minaris Advanced Therapies for U.S. Manufacturing of NurOwn® for Upcoming Phase 3b Clinical Trial in ALS. [Press release]. Retrieved from https://www.globenewswire.com/news-release/2023/03/28/2615314/0/en/BrainStorm-Announces-Manufacturing-Agreement-with-Minaris-Advanced-Therapies-for-U-S-Manufacturing-of-NurOwn-for-Upcoming-Phase-3b-Clinical-Trial-in-ALS.html
- This strategic partnership between BrainStorm Cell Therapeutics Inc. and Minaris Advanced Therapies, focusing on the United States manufacturing of NurOwn®, is a significant step in the cloud-based health-and-wellness sector, aiming to bring innovative medical-conditions treatments to patients suffering from debilitating conditions like Amyotrophic Lateral Sclerosis (ALS).
- The collaboration, announced by both parties in their respective press releases, anticipates a high-quality, scalable production capability that will meet the demands of the pivotal Phase 3b clinical trial of NurOwn® and, if results are favorable, prepare for its eventual commercialization.
- With the robust production capabilities established through this partnership, BrainStorm Cell Therapeutics, in association with Minaris Advanced Therapies, is well-positioned to deliver its ground-breaking stem cell therapy for ALS, setting the stage for potential science advancements and improvement in patients' health-and-wellness.
