NurExone Plans Small-Scale of ExoPTEN Clinical Manufacturing in Preparation for FUTURE First in Human USE Pathways
Executive Summary
- NurExone began evaluating Israeli contract manufacturers for small‑scale GMP production of its lead exosome‑siRNA candidate ExoPTEN, a prerequisite for future First‑in‑Human studies.
- New analytical testing showed the company’s MSC‑derived exosomes have significantly higher CD73‑associated activity than a commercial control (p < 0.01), supporting the potency of the platform.
- The Company engaged Russo Partners LLC for a two‑month strategic communications consulting project at a fixed fee of US$6,600, pending TSX‑V approval.
Key Details
- Manufacturing partner search:
- Evaluating multiple Israeli firms with GMP‑aligned capabilities to produce small clinical‑grade batches of ExoPTEN for early de‑risking and process validation.
-
Plan: initial runs in Israel, followed by scale‑up in the United States once validation is complete.
-
Scientific data – CD73 activity:
- Exosomes derived from human bone‑marrow MSCs showed a statistically significant increase in AMP‑to‑adenosine conversion per particle versus a commercial MSC exosome control (t‑test, p < 0.01).
-
Results were based on two manufacturing batches; the higher activity is linked to stronger anti‑inflammatory/healing signaling potential.
-
Master Cell Bank & technology:
-
Data validate the quality of NurExone’s Master Cell Bank and its patented 3‑D shear‑force production technology, indicating the ability to generate higher‑potency exosomes at scale.
-
Regulatory outlook:
-
No compassionate‑use or clinical manufacturing is underway; all activities remain contingent on regulatory engagement and approval.
-
Russo Partners engagement:
- Fixed‑fee consulting agreement for up to two months, total US$6,600.
- Either party may terminate with 30 days’ notice.
-
Russo has no current equity interest in NurExone; future purchases would comply with securities laws and TSX‑V policies.
-
Leadership comments:
- CEO Dr. Lior Shaltiel highlighted the strategic importance of early GMP manufacturing for de‑risking and preparing a First‑in‑Human submission when regulatory pathways allow.
- Head of CMC, Dr. Ina Sarel, emphasized Israel as the starting point for small‑scale production before U.S. scale‑up.
Notable Quotes
- “This is a strategically important next phase of operational de‑risking.” – Dr. Ina Sarel, Head of CMC, Quality and Regulatory Affairs
- “ExoPTEN brings together a powerful synergistic impact with highly active exosomes produced, combined with a targeted siRNA.” – Dr. Lior Shaltier, CEO
Materiality Assessment: Non‑Material – Positive (operational progress and supportive preclinical data, but no immediate revenue or regulatory milestone).