Phio takes a lead in its Drug Development Program for PH-762

Announcement

Phio Pharmaceuticals Corp., a well-known clinical-level siRNA biopharmaceutical company discovering therapeutics with its exclusive INTASYL® gene mutation technology to treat cancer. The company has announced that it has taken a crucial step in its drug development program for PH-762. This step will help the company to excel in its drug and clinical development growth.

Next move

Phio will start with a toxicology study, which is fundamental by the FDA, before conducting a human pivotal trial. Simultaneously, the efforts are building an advanced space for the delivery pattern of marketing viable drug products from next year that aligns with the FDA’s recent Good Manufacturing Practices. Most of the net proceeds from the company’s current financing are dedicated to these two main initiatives. This step is important to achieve the clinical development stage.

For now, the positive and promising interim efficacy and safety results are listed in the running Phase 1b dose escalation clinical trial, harnessed with the PH-762, an INTASYL compound to cure skin cancer. Recentle around 18 cutaneous carcinoma patients have finished with the treatment throughout five dose escalating groups in the Phase 1b trial. The aggregated pathologic response in cSCC 16 patients, along with six patients with a full response, with 100% clearance.

Also, it includes two with a partial response of >50% clearance and two with a near complete response rate covering >90% clearance. One patient diagnosed with metastatic Merkel cell carcinoma showed a partial response with >50% clearance. The one patient with metastatic melanoma and six patients with cSCC had a pathologic non-response with <50% clearance.

As of now, there’s no 100% clicical progression of disease in any patients. As observed, there were no clinically suitable and proven treatments or medicines limiting the toxicities or immediate negative effects in the patients taking intratumoral PH-762 in this trial period. Nevertheless, PH-762 showed a convincing tolerability rate in each participated patients in every escalating dose group.

Chairman and CEO of Phio Pharmaceuticals, Robert Bitterman, said, “The start of this nonclinical study is a meaningful step in succeeding the drug development journey of PH-762 to NDA approval. The company’s meeting with the FDA is important in upgrading our development strategy for PH-762. These efforts to serve marketised viable drug products from our hardworking US suppliers are lined up next in 2026. This is the next crucial advancement in our robust drug development program of PH-762.”