Phio Pharmaceuticals Corp. announced that it has received regulatory clearance to start a clinical trial with its lead product candidate, PH-762. The Company was granted the clinical trial authorization (CTA) by the French National Agency for the Safety of Medicines and Health Products (ANSM - L'Agence nationale de sécurité du médicament et des produits de santé) to proceed with a first-in-human clinical trial for PH-762 to treat patients with melanoma at the Gustave Roussy Institute.

The Company expects to dose the first patient in the first quarter of 2022. PH-762 activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy.

PD-1 is expressed by T cells and prevents them from killing other cells, including cancer cells. Therefore, reducing PD-1 expression can reduce the ability of cancer cells to evade T cell detection and killing. In preclinical studies, PH-762 has demonstrated robust and durable efficacy in various in vivo tumor models, and importantly has shown that it can elicit an abscopal effect or systemic immune response after local administration.