Phio Pharmaceuticals Announces Regulatory Clearance of Clinical Trial to Treat Solid Tumors

Phio Pharmaceuticals has announced their clinical development partner, AgonOx, has received confirmation from the FDA that their planned Phase 1 clinical trial in patients with advanced solid tumors may proceed. The initial Phase 1 clinical trial is designed to assess safety and to study the potential for an enhanced therapeutic benefit from the administration of Phio’s PH-762 treated “double positive” (DP) CD8 tumor infiltrating lymphocyte (TIL) in patients with melanoma and other advanced solid tumors.

Phio is a clinical stage biotechnology company whose proprietary INTASYL™ RNAi technology is designed to make immune cells more effective in killing tumor cells. Phio’s PH-762 is an INTASYL compound that reduces the expression of PD-1, a protein that inhibits T cells’ ability to kill cancer cells. By decreasing PD-1 expression, the T cells have increased capacity to kill cancer cells. AgonOx, in collaboration with the Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon, has shown that DP CD8 T cells sorted from human solid tumors (AGX148) are highly enriched for tumor-reactivity leading to increased tumor killing when compared to the other CD8 tumor infiltrating lymphocyte (TIL) subsets.

Preclinical data from in-vitro studies using autologous human tumor cells demonstrated that treating AGX148 with Phio’s PH-762 increased by two-fold their tumor killing activity. The trial will be conducted at Providence under the leadership of Dr. Weinberg and Principal Investigator Brendan Curti, MD, Medical Oncologist and Robert W. Franz Endowed Chair for Clinical Research.

“We’re pleased to have reached this important milestone in our collaboration with AgonOx and Providence Cancer Institute to develop improved cell therapies for cancer patients,” said Robert Bitterman, Phio’s Principal Executive Officer and Executive Chairman.

“This bench to bedside research has the potential to help patients with solid malignancies and this is the first step to bringing this therapy to patients,” said Andrew Weinberg, PhD, Founder and Chief Scientific Officer at AgonOx, Inc. and Research Scientist/Judy Hartmann Endowed Chair at Providence.