Phio advances PH-762 cancer therapy toward Phase 2b

• Phio Pharmaceuticals (NASDAQ:PHIO) submitted an FDA meeting request and briefing package to advance PH-762 development in cutaneous squamous cell carcinoma.
• The package includes Phase 1b clinical data, nonclinical studies, pharmacology information, and the proposed Phase 2b neoadjuvant trial design.
• Phio expects clinical trial supplies for the planned Phase 2b study to be available in the first quarter of 2027.

Phio Pharmaceuticals (NASDAQ:PHIO) submitted a meeting request and comprehensive briefing package to the U.S. Food and Drug Administration to support the next phase of development for its INTASYL siRNA candidate PH-762.

The submission focuses on advancing PH-762 in cutaneous squamous cell carcinoma and includes data from the completed Phase 1b clinical study, integrated clinical pharmacology results, and the company’s nonclinical development program.

The package also outlines Phio’s proposed Phase 2b neoadjuvant trial, including the scientific rationale, study design, and pharmacokinetic strategy intended to support further clinical evaluation.

Phio said the FDA interaction will help guide the next stage of the PH-762 program as the company prepares for later-stage development.

The company is also preparing manufacturing activities for clinical trial supplies, which are expected to be available in the first quarter of 2027.

Phio reported completion of the dosing phase of its nonclinical toxicology study, with remaining activities supporting advancement into the next clinical stage expected to conclude in the first quarter of 2027.