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Phio Pharmaceuticals, AgonOx Start Phase I Trial of T-Cell Immunotherapy Combination

NEW YORK – Phio Pharmaceuticals on Wednesday announced it will work with AgonOx to begin Phase I testing of a T-cell immunotherapy combination in patients with advanced solid tumors including melanoma.

Phio and AgonOx have begun enrolling the trial, in which they will evaluate the safety and preliminary efficacy of the self-delivering RNAi compound PH-762 plus AgonOx's "double-positive" CD8 autologous tumor-infiltrating lymphocyte (TIL) technology. After a site initiation visit, the companies have decided to conduct the trial at Providence Cancer Institute in Portland, Oregon.

Phio and AgonOx initially inked the clinical trial collaboration in 2021. Under the terms of the agreement, Marlborough, Massachusetts-based Phio is financially supporting the trial and is entitled to future development milestone payments from AgonOx as well as potential sales-based royalties.

PH-762, which is rooted in Phio's RNAi technology dubbed Intasyl, is designed to silence PD-1 expression on T cells to increase TIL efficacy. According to Phio, its Intasyl drugs can target proteins without the need for specialized formulations or drug delivery systems.

"With both regulatory clearance and the completion of the site initiation visit, this study can now proceed, and we are excited to test PH-762 combined with this new TIL therapy," AgonOx President and CSO Andrew Weinberg said in a statement.

AgonOx is a Providence Cancer Institute spinoff. Its TIL therapies use a method designed to identify, isolate, and expand CD103-positive and CD39-positive tumor-infiltrating CD8 T cells harvested from patients.