On February 10, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported that an independent Data Monitoring Committee (DMC) completed its prespecified review of interim safety data in the Company’s Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma (Press release, Phio Pharmaceuticals, FEB 10, 2023, View Source [SID1234627075]). The trial is ongoing at the Gustave Roussy Institute (Villejuif, France), one of the largest cancer centers in Europe. PH-762 is an INTASYL compound that reduces the expression of cell death Protein 1 (PD-1), a protein that inhibits T cells’ ability to kill cancer cells. Decreasing the expression of PD-1 increases the capacity of T cells to kill cancer cells.
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Following completion of the treatment period through excision of the tumor, safety data from the initial cohort of three subjects in the Phase 1 trial was evaluated by the DMC. The safety data review disclosed no dose-limiting toxicity, and no drug-related severe adverse events or serious adverse events, and the DMC recommended proceeding to the enrollment of the subsequent dose cohort, as intended per the study protocol.
"We are pleased with the recommendation of the DMC as a reflection of the favorable safety and tolerability profile of PH-762 to date, and will continue to obtain additional safety data as well as evidence of pharmacologic effect as we develop PH-762 for advanced cutaneous tumors," said Robert Bitterman, Phio’s Principal Executive Officer and Executive Chairman.
In addition to the Phase 1b study in France, Phio expects to commence a US Phase 1b clinical trial focusing on the treatment of cutaneous squamous cell carcinoma (cSCC) and other selected cutaneous malignancies, early in the 2nd half of 2023.
About the Phase 1b Trial in Advanced Melanoma
The Phase 1b trial is an open-label, dose escalation trial that is expected to enroll up to 21 patients with advanced melanoma. PH-762 will be administered as a neoadjuvant monotherapy intratumorally once a week, for a total of four injections, across five dose levels which are normalized to tumor volume. Dosing will be followed by tumoral excision after an additional two weeks. The primary study objectives are: to evaluate the safety and tolerability, and pharmacokinetics of PH-762; to determine the potential immunologic and pathologic tumor responses; and to determine the recommended dose for later clinical studies. Tumor changes will be evaluated per RECIST criteria, adapted for use with intratumoral therapy, and by pathological response.
About INTASYL
INTASYL compounds are chemically modified siRNAs that provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity, targeting a broad range of cell types and tissues. INTASYL drugs precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy (ACT) applications.
In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial dosing convenience to the prescriber and patient. INTASYL is the only self-delivering RNA interference (RNAi) technology focused on immuno-oncology therapeutics.