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.
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.