Phio Pharma completes first commercial-scale cGMP batch of PH-762

Phio Pharmaceuticals Corp. (NASDAQ: PHIO) announced the successful release of its first commercial-scale current Good Manufacturing Practice (cGMP) batch of PH-762 drug substance, according to a company statement.

The batch was manufactured in compliance with cGMP regulations, the approved Master Batch Record, and ICH Q7 guidelines, and was confirmed by a Certificate of Analysis and Certificate of Compliance.

The drug substance will proceed through final drug product completion steps for use in a planned Phase 2b clinical study, which the company expects to initiate in the first quarter of 2027.

PH-762 is an siRNA compound that targets the PD-1 gene and is being evaluated as a potential non-surgical treatment for skin cancers, including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. A Phase 1b trial previously evaluated PH-762 across those indications.

"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."

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