On October 13, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary INTASYL siRNA gene-silencing platform, reported the successful release of its first commercial-scale cGMP batch of PH-762 drug substance (active pharmaceutical ingredient), representing a critical operational and strategic milestone as the Company advances PH-762 to the next stage of clinical development.
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The batch was manufactured in accordance with established specifications and quality requirements, as confirmed by the accompanying Certificate of Analysis and Certificate of Compliance. Manufacturing was conducted in compliance with current Good Manufacturing Practice (cGMP) regulations, the approved Master Batch Record, and applicable ICH Q7 guidelines.
Validated drug substance will now proceed through the final steps of drug product completion for use in Phio’s planned Phase 2b clinical study, which is expected to be initiated in the first quarter of 2027. Successful completion of this commercial-scale manufacturing milestone underscores the Company’s supply chain readiness and supports the next steps in its clinical development and potential commercialization strategy for PH-762.
"This achievement culminates a complex coordination and cross functional execution process started some 16 months ago among numerous highly skilled scientists and engineers," said Robert Bitterman, President and CEO of Phio Pharmaceuticals. "This is a meaningful advancement in the PH-762 program, mitigating key development and manufacturing risks, and positions the Company to execute on important upcoming clinical and regulatory milestones."
(Press release, Phio Pharmaceuticals, OCT 13, 2026, View Source [SID1234673357])