Phio Pharmaceuticals Completes First Commercial-Scale cGMP Batch of PH-762 Drug Substance Ahead of Phase 2b

Sixteen months of cross-functional CMC coordination have produced a released drug substance batch for Phio Pharmaceuticals, clearing one of the more consequential manufacturing gates between clinical-stage development and a planned Phase 2b trial initiation in Q1 2027. For CMC leads and QA directors tracking small-biotech manufacturing risk, the release signals that commercial-scale process transfer and batch disposition can be executed without a late-stage manufacturing hold.

The batch was manufactured under current Good Manufacturing Practice (cGMP) regulations, against an approved Master Batch Record, and in conformance with ICH Q7 active pharmaceutical ingredient guidelines. Release was supported by a Certificate of Analysis and Certificate of Compliance, confirming the batch met established specifications. The drug substance will now advance through final drug product completion steps before entering the Phase 2b study supply chain.

PH-762 is an INTASYL siRNA compound targeting PD-1 gene silencing, developed for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. The Phase 1b trial (NCT# 06014086) evaluated the compound across those indications; the upcoming Phase 2b study represents the next formal clinical and regulatory checkpoint for the program.

President and CEO Robert Bitterman described the milestone as the culmination of a 16-month coordination effort across scientific and engineering functions, framing it explicitly as a risk-mitigation outcome: key development and manufacturing risks have been reduced, and the company is positioned to execute on upcoming clinical and regulatory milestones. For QA and regulatory affairs leads, that framing is operationally relevant, first commercial-scale batches carry disproportionate process validation exposure, and a clean release at this stage reduces the probability of CMC-driven clinical holds downstream.

Drug product completion is the remaining manufacturing step before Phase 2b supply readiness is confirmed, with that work expected to conclude ahead of the Q1 2027 trial start.