Phio Pharmaceuticals Corp. (PHIO), a clinical-stage siRNA biopharmaceutical, announced that it has taken a critical step forward by commencing a toxicology study, which the FDA requires before beginning a human pivotal trial in its drug development program for PH-762.
In parallel, Phio reported that initiatives are underway to advance the delivery of a commercially viable product in 2026 that meets FDA current Good Manufacturing Practices. Both the major initiatives are funded by Phio's recent financing.
Notably, in July 2025, the Company entered into a comprehensive drug substance development services agreement with a U.S. manufacturing company, by which the manufacturer will provide analytical, process development, and current Good Manufacturing Practices or cGMP manufacturing of clinical supplies for PH-762.
Phio's lead INTASYL compound, PH-762, silences the PD-1 gene implicated in various forms of skin cancer. The ongoing Phase 1b trial evaluates PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma as a potential non-surgical treatment for skin cancers.
Recently, positive interim safety and efficacy results were reported in the ongoing Phase 1b dose escalation clinical trial PH-762.So far, a total of 18 patients with cutaneous carcinomas have completed treatment across five dose-escalating cohorts in the Phase 1b trial.
Out of 18 with cSCC, six patients had a complete response with 100% clearance,2 had above 90% clearance and 2 had a partial response above 50% clearance. Six patients with cSCC and one patient with metastatic melanoma had less than 50% clearance, indicating a pathologic non-response.
Robert Bitterman, CEO and Chairman of Phio, said that conducting the said nonclinical study as a significant step toward advancing the drug development pathway for PH-762 toward NDA approval, and added that Phio's communication with the FDA is essential for their development strategy for PH-762.
Over the year, PHIO has traded in the range of $0.9660 to $9.79.
On Tuesday, PHIO closed trading 6.36% down at $1.03.
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