NurExone Plans Small-Scale of ExoPTEN Clinical Manufacturing in Preparation for FUTURE First in Human USE Pathways

Core Insights - NurExone Biologic Inc. is making significant progress in its long-term clinical-readiness strategy by evaluating potential Israeli production partners for small-scale GMP-based manufacturing of its lead candidate, ExoPTEN, aimed at treating central nervous system injuries [1][4] Group 1: Product Development - ExoPTEN combines highly active exosomes with targeted siRNA, and the company is preparing for a First-in-Human use submission pending regulatory approval [2] - ExoPTEN is being developed for acute spinal cord injury and optic nerve injury, with the prioritization of indications yet to be determined [2] - New scientific data shows that NurExone's exosomes exhibit significantly higher CD73-associated biological activity compared to commercially available exosomes, reinforcing confidence in the platform [5][6] Group 2: Manufacturing Strategy - NurExone is assessing several Israeli manufacturing organizations for small-scale ExoPTEN production aligned with future clinical requirements [3] - The initial GMP production will take place in Israel, followed by a transition to the United States for scale-up [4] Group 3: Scientific Validation - Recent analytical testing indicates that NurExone's exosomes have a statistically significant higher conversion rate of adenosine monophosphate to adenosine, suggesting stronger regenerative potential [6][7] - The findings validate the potency of NurExone's therapeutic exosomes and support their use as a delivery vehicle in ExoPTEN [7] Group 4: Strategic Engagement - NurExone has engaged Russo Partners LLC for strategic communications support, subject to TSX Venture Exchange approval, for a fixed fee of US$6,600 [8]