Phio Pharmaceuticals Announces FDA Clearance to Initiate Clinical Trial of PH-762 for Treatment of Skin Carcinomas

Phio Pharmaceuticals, a clinical-stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to proceed with a clinical trial of Phio’s lead product candidate, PH-762. PH-762 is an INTASYL compound that reduces the expression of PD-1, a protein that inhibits T cells’ ability to kill cancer cells. Phio plans to initiate its Phase 1b clinical trial of intratumoral PH-762 in patients with cutaneous squamous cell carcinomas, melanoma and Merkel cell in the second half of 2023.

“The clearance of our IND application for PH-762 represents a significant milestone in Phio’s continued evolution from drug discovery to clinical development,” said Phio’s President and CEO, Robert Bitterman.

Dr. Mary Spellman, Acting Chief Medical Officer, Phio, added, “Cutaneous malignancies may be both locally destructive and systemically devastating and we look forward to investigating this new immuno-oncology approach to treat these carcinomas.”

The initial multi-center, dose-escalating, Phase 1b clinical trial under Phio’s cleared IND is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762. Phio will focus its efforts on the U.S. clinical trial and intends to wind down its first-in-human clinical trial for PH-762 in France, which was limited to the treatment of patients with metastatic melanoma. PH-762 has also received clearance to proceed under an IND sponsored by AgonOx, Inc. in a clinical trial evaluating PH-762 treated “double positive” (DP) CD8 tumor-infiltrating lymphocytes (TIL) in patients with melanoma and other advanced solid tumors.