On November 7, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biotechnology company creating new pathways towards a cancer-free future by using its INTASYL siRNA gene silencing technology designed to make the body’s immune cells more effective in killing cancer cells, reported that it is presenting clinical data from its on-going Phase 1b clinical trial at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which will be held in Houston, TX from November 8-10, 2024 (Press release, Phio Pharmaceuticals, NOV 7, 2024, View Source [SID1234647943]).
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Phio’s presentation will highlight the clinical results from enrolled patients in Cohorts 1 and 2 in the Phase 1b dose escalation clinical trial. This clinical trial is designed to evaluate the safety and tolerability of intratumoral injection of PH-762 in patients with cutaneous squamous carcinoma, Merkel cell carcinoma and melanoma.
Clinical Results To Date
Intratumoral (IT) injection of PH-762 has been well tolerated in all patients enrolled in the trial to date. There were no related adverse events, no serious adverse events, and no dose limiting toxicities or dose adjustments. Five (5) patients with cutaneous carcinomas have enrolled in Cohorts 1 and 2. Each enrolled patient received four (4) IT doses of PH-762. The patients were diagnosed with cutaneous squamous cell carcinoma (4 patients) and metastatic melanoma (1 patient).
At Day 36 (tumor excision), while each patient in the first cohort had stable disease, the following results were described for two patients enrolled in the second cohort:
· Complete response (100% tumor clearance) reported for 1 patient with cutaneous squamous cell carcinoma; and
· Partial response (90% tumor clearance) reported for 1 patient with cutaneous squamous cell carcinoma.
The Phase 1b trial is on-going. Anticipated completion of the enrollment phase of this trial is Q3 2025.
"We are encouraged by the documented clinical and histopathological results observed to date," said Mary Spellman MD, Phio’s acting Chief Medical Officer. "Corresponding safety and tolerability data supports continued assessment of intratumoral PH-762 in patients with cutaneous carcinomas."
Presentation Details are as follows:
Title: INTASYL PH-762: PD-1 Directed Intratumoral Immunotherapy for Cutaneous Carcinoma
Abstract Number: 696
Presenting Author: Mary Spellman, M.D.
Date: Saturday November 9, 2024
Location: Exhibit Halls A and B, George R. Brown Convention Center