Phio Pharmaceuticals Corp. (NASDAQ: PHIO) announced on October 13, 2026, that it has successfully completed its first commercial-scale batch of PH-762 drug substance. The batch was manufactured in accordance with current Good Manufacturing Practice (cGMP) regulations and applicable ICH Q7 guidelines, as confirmed by a Certificate of Analysis and Certificate of Compliance.
The company stated that the validated drug substance will proceed through final steps to become drug product for use in a planned Phase 2b clinical study. This milestone is intended to support the supply chain readiness for PH-762, a lead clinical development program based on the company's proprietary INTASYL siRNA gene silencing technology.
According to the filing, the Phase 2b study is expected to be initiated in the first quarter of 2027. The company previously conducted a Phase 1b trial (NCT# 06014086) for PH-762, evaluating the compound for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.
Robert J. Bitterman, President and CEO of Phio Pharmaceuticals, noted that the achievement culminates a process involving cross-functional execution started approximately 16 months prior.
