Drugs / PH-762
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PH-762

Developed for
cutaneous melanoma · cutaneous neuroendocrine carcinoma · skin squamous cell carcinoma
Investigated by
Phio Pharmaceuticals Inc. · Prosoft Clinical

Trials 1

202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT06014086 Nov 2023 → Dec 2025 overdue cutaneous melanoma, cutaneous neuroendocrine carcinoma, skin squamous cell carcinoma Phio Pharmaceuticals Inc. Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 35

DateIssuerRelease
2026-09-14 Phio Pharmaceuticals Inc. Regulatory Phio Announces Key Development Milestone for PH-762 with FDA Submission Supporting Next Stage of Clinical Development in Cutaneous Squamous Cell Carcinoma phiopharma.com ↗
Phio announced today that, following the formal completion of the Phase 1b clinical study, it has submitted a meeting request and comprehensive briefing package to the U.S. Food and Drug Administration (FDA).
2026-03-23 Phio Pharmaceuticals Inc. Results Phio Pharmaceuticals Announces American Academy of Dermatology 2026 Presentation Featuring Clinical Study Results from Study of PH-762 for Cutaneous Carcinoma Underscoring Clinical Pipeline Advancement phiopharma.com ↗
2026-03-05 Phio Pharmaceuticals Inc. Results Phio Pharmaceuticals Reports 2025 Year-End Financial Results and Business Update phiopharma.com ↗
Concluding the Phase 1b study with favorable safety, tolerability and pathology data, advancing the CMC and toxicology initiatives while extending our cash runway into 2027 are noteworthy milestones on our continuing pathway to potential approval.
2026-02-10 Phio Pharmaceuticals Inc. Results Phio Announces Safety Monitoring Committee’s (SMC) Positive Wrap-up on Lead Clinical Candidate PH-762 in Skin Cancer Trial phiopharma.com ↗
No dose-limiting toxicities or serious adverse events have been reported for any of the 22 enrolled patients who completed 4 intratumoral injections of PH-762 and have been followed through at least 4 weeks after the final injection.
2026-01-20 Phio Pharmaceuticals Inc. Results Phio Pharmaceuticals Announces Key Tumor Response Data from all Cohorts in Intratumoral PH-762 Dose Escalation Cutaneous Carcinoma Trial phiopharma.com ↗
Pathology data indicate 70% overall response rate for squamous cell carcinomas: 100% clearance in 10 out of 14 responders
2025-12-23 Phio Pharmaceuticals Inc. Regulatory Phio Pharmaceuticals Announces Significant Step Forward in its Drug Development Program for PH-762 phiopharma.com ↗
The company will begin a toxicology study, which is required by the FDA prior to commencing a human pivotal trial.
2025-11-13 Phio Pharmaceuticals Inc. Results Phio Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Business Update phiopharma.com ↗
To date, pathologic results for the fifth and final cohort were as follows: 100% tumor clearance in one of three patients, > 90% clearance in the second patient, and > 50% clearance in the third patient at Day 36.
2025-11-03 Phio Pharmaceuticals Inc. Results Phio Pharmaceuticals Announces Positive Pathology Results: Final Maximum Dose Cohort for INTASYL PH-762 Skin Cancer Trial phiopharma.com ↗
The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance).
2025-07-25 Phio Pharmaceuticals Inc. Results Phio Pharmaceuticals Announces Pathology Results for Four of Five Patients in Fourth Cohort phiopharma.com ↗
Phio announced today that pathologic results are available for four of the five patients treated in the fourth cohort.
2025-06-25 Phio Pharmaceuticals Inc. Results Phio Pharmaceuticals Announces Positive Safety Monitoring Committee Recommendation to Advance INTASYL PH-762 Skin Cancer Clinical Trial to Fifth Dose Escalation Cohort phiopharma.com ↗
As with the previous three cohorts, injections were well-tolerated and there were no dose-limiting toxicities, serious adverse events, or clinically relevant treatment-emergent adverse reactions reported.
2025-05-07 Phio Pharmaceuticals Inc. Results Phio Pharmaceuticals Announces Positive Pathology Results in Third Cohort in INTASYL PH-762 Skin Cancer Clinical Trial phiopharma.com ↗
Phio announced today that a complete pathologic response (100% tumor clearance) has been reported for 2 of 3 patients with cutaneous squamous cell carcinoma (cSCC) treated in the third dose cohort.
2025-04-09 Phio Pharmaceuticals Inc. Results Phio Pharmaceuticals Announces Positive Safety Monitoring Committee Recommendation to Advance INTASYL PH-762 Skin Cancer Study to Fourth Dose Escalation Cohort phiopharma.com ↗
Phio announced today that the Safety Monitoring Committee (SMC) recommended dose escalation in Phio’s Phase 1b clinical trial (NCT 06014086) for Phio’s lead product candidate, PH-762.

All press releases naming this drug 51 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as PH-762 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06014086 ↗
Action Inhibit “PH-762 can inhibit the immune checkpoint PD-1 in the tumor” NCT06014086 ↗
Route Other “intratumoral injections of PH-762” NCT06014086 ↗