Phio Secures U.S. cGMP Manufacturing for PH-762 After 65% Response in Phase 1b
Phio signed a cGMP manufacturing agreement with a U.S. supplier to produce its lead siRNA candidate PH-762 for clinical and commercial supply. In its Phase 1b trial of 22 cutaneous carcinoma patients, PH-762 showed no dose-limiting toxicities with a 65% pathological response rate, including 85% in the highest-dose cohort.
1. Manufacturing Agreement for PH-762
Phio entered into a cGMP drug product manufacturing services agreement with a U.S. partner to supply its lead INTASYL® siRNA candidate, PH-762, for upcoming clinical trials and eventual commercial launch. This partnership secures production capacity and strategic advantages of a domestic supplier, supporting scale-up and regulatory compliance.
2. Phase 1b Trial Outcomes
In the Phase 1b intratumoral study, 22 patients with cutaneous carcinomas were treated across five dose-escalation cohorts. PH-762 demonstrated no dose-limiting toxicities or serious adverse events, achieving a 65% pathological response rate overall and an 85% rate in the highest-dose cohort.
3. Financial Outlook and Regulatory Path
Phio reports cash and equivalents sufficient to fund operations into the first half of 2027. The company targets FDA engagement in Q2 2026 to discuss next-stage clinical development plans for PH-762, aiming to advance into pivotal trials.