NurExone Transfers ExoPTEN Manufacturing to GMP Facility

NurExone Biologic Inc., a leading biopharmaceutical company based in Toronto and Haifa, Israel, has announced a significant advancement in its regenerative medicine endeavors. The company has successfully transitioned the manufacturing of the small interfering RNA (siRNA) sequence for its premier ExoPTEN nanodrug to a Good Manufacturing Practice (GMP) compliant facility in Germany. This strategic move is critical for producing the drug for clinical trials and eventual commercial distribution.

The siRNA sequence underwent thorough validation at the new GMP-compliant site, underscoring NurExone’s dedication to advancing regenerative medicine solutions and ensuring the capability to meet future clinical manufacturing needs. The transfer to a GMP-grade manufacturer is a pivotal step as it aligns production with the stringent quality and regulatory standards essential for clinical trial materials.

NurExone has reported that the new vendor's siRNA demonstrated an approximately 80% reduction in the expression of PTEN (Phosphatase and Tensin Homolog), showcasing its potency and efficacy on par with the siRNA produced by the company’s previous research-grade supplier. The ExoPTEN nanodrug, which is still in development, is designed to use PTEN inhibition to promote nerve growth and regeneration following injury or damage.

In an illustrative experiment, both research-grade and GMP-grade siRNA were shown to effectively downregulate PTEN mRNA in a neuroblastoma cell line, indicating comparable efficacy between the two sources. This finding is visually represented in a figure that depicts the relative expression levels of PTEN mRNA under three conditions: untreated cells, cells treated with research-grade siRNA, and cells treated with GMP-grade siRNA.

Dr. Lior Shaltiel, CEO of NurExone, expressed his enthusiasm about the successful tech transfer to a new GMP-compliant manufacturer for the siRNA sequence, highlighting it as a foundational achievement for the future GMP production of potent and proprietary products. He emphasized that meeting the rigorous quality and regulatory standards required for clinical trials marks a critical phase in the development of the ExoPTEN nanodrug.

GMP encompasses a series of regulations, guidelines, and procedures that ensure products are consistently produced and controlled to high-quality standards, which is crucial for any pharmaceutical undertaking.

NurExone Biologic Inc., listed on the TSXV, is developing a platform for biologically-guided exosome-based therapies aimed at noninvasively treating patients with Central Nervous System injuries. The company’s flagship product, ExoPTEN, has shown promising results in preclinical trials, recovering motor function in 75% of laboratory rats with acute spinal cord injuries when administered intranasally. Furthermore, ExoPTEN has received Orphan Drug Designation from the FDA, and the company’s platform technology is expected to provide innovative solutions for drug companies seeking noninvasive targeted drug delivery methods for various conditions.

With these advancements, NurExone Biologic Inc. remains at the forefront of regenerative medicine, striving to bring revolutionary therapies to market and improve patient outcomes through cutting-edge biopharmaceutical developments.

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