Phio Pharmaceuticals Corp. reported that in the final, fifth cohort of its Phase 1b intratumoral PH‑762 trial, three patients achieved pathologic responses: one patient achieved 100 % tumor clearance, a second achieved greater than 90 % clearance, and a third achieved greater than 50 % clearance. Across all five dose‑escalation cohorts, 18 patients completed treatment, with 16 patients showing a pathologic response in cutaneous squamous cell carcinoma (cSCC). The responses included six complete responses, two near‑complete responses, and two partial responses. A single patient with metastatic Merkel cell carcinoma achieved a partial response, and no patients experienced clinical disease progression.
The safety monitoring committee reviewed data for the maximum‑dose cohort and found no dose‑limiting toxicities or clinically relevant treatment‑emergent adverse events. PH‑762 was well tolerated, with no immune‑related adverse events reported, and the safety profile remained favorable across the dose range, which increased approximately twenty‑fold from the first cohort.
The trial evaluated PH‑762 as a neoadjuvant, intratumoral therapy, delivering four weekly injections and assessing pathologic response roughly five weeks after the first dose. The study targeted patients with stage 1, 2, and 4 cSCC, stage 4 melanoma, and stage 4 Merkel cell carcinoma. The trial identifier is NCT06014086.
PH‑762 is an INTASYL™ siRNA compound that targets the PD‑1 gene, a key regulator of T‑cell activity. The INTASYL platform is a self‑delivering RNAi technology designed to silence genes that tumors use to evade the immune system. CEO Robert Bitterman said the results demonstrate the promise of PH‑762 as a viable non‑surgical treatment for cutaneous carcinomas and underscore the potential of Phio’s INTASYL platform to transform skin‑cancer therapy.
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