NurExone Biologic Inc, a pioneering biopharmaceutical company, is thrilled to announce an important milestone in its regenerative medicine efforts. The Company has successfully transferred the manufacturing of the small interfering RNA (“siRNA”) sequence for its flagship ExoPTEN nanodrug to a German producer with Good Manufacturing Practice (“GMP”) capabilities. A move to a GMP-grade manufacturer is essential for producing a drug for clinical trials and commercial sale.

The siRNA sequence was validated at the new GMP partner, solidifying the Company’s commitment to advancing regenerative medicine therapies and strengthening its confidence in meeting future clinical manufacturing demands.

NurExone reports that the siRNA from the new vendor achieved an approximately 80% reduction in expression of PTEN (Phosphatase and Tensin Homolog), demonstrating potency and effectiveness that is comparable to the siRNA from the Company’s previous, research-grade producer. NurExone’s ExoPTEN nanodrug, that is still under development, uses PTEN inhibition to facilitate nerve growth and regeneration after injury or damage. Figure 1 below shows that both the research-grade and the new GMP vendor’s siRNA effectively downregulate PTEN mRNA in a neuroblastoma cell line with comparable efficacy.

Dr. Lior Shaltiel, CEO of NurExone, stated: “The tech transfer to a new GMP-compliant vendor for our siRNA sequence is a significant achievement, establishing the foundation for future GMP manufacture of a potent and patented product. Achieving production that meets the strict quality and regulatory standards necessary for clinical trials is a critical step in the development of our ExoPTEN nanodrug."

GMP is a system of regulations, guidelines, and procedures intended to ensure that products are produced and controlled according to quality standards.