Phio Pharmaceuticals (NASDAQ: PHIO) surged nearly 92% in early trading after announcing that its lead siRNA candidate, PH-762, has received the green light to advance to the next dose level in its ongoing Phase 1b skin cancer trial. The decision follows a positive safety review by the study’s Safety Monitoring Committee (SMC), which determined that the treatment was well-tolerated in the third dosing cohort.
The trial is evaluating PH-762 as a neoadjuvant, intratumoral therapy for several aggressive skin cancers, including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. Using Phio’s proprietary INTASYL® platform, PH-762 is designed to silence PD-1 gene expression, reactivating the immune system’s ability to attack cancer cells locally at the tumor site.
The third cohort included three patients with cutaneous squamous cell carcinoma who received escalating doses of PH-762. According to the company, the treatment showed no dose-limiting toxicities or serious adverse events, paving the way for enrollment into the fourth and highest planned dose cohort.
Earlier data from the first two cohorts provide early signs of clinical activity. In the second dose group, two patients demonstrated complete tumor clearance (100%) by Day 36, while a third achieved a 90% reduction. These results, though preliminary and from a small sample, suggest that PH-762 could offer a potent non-surgical alternative for patients with localized skin cancer.
Phio’s acting Chief Medical Officer, Dr. Mary Spellman, noted the consistency of the compound’s safety profile across all three dose levels to date. CEO Robert Bitterman added that PH-762 may ultimately offer a “viable non-surgical alternative to existing modes of therapy for skin cancer,” underscoring the compound’s clinical potential.
The study (NCT# 06014086) is being conducted across multiple centers and is structured as a dose-escalation trial to determine both safety and the recommended dose for future development. While efficacy data from the third cohort are still pending, the clearance to proceed to a higher dose marks a meaningful inflection point in the trial’s progression.
PH-762 represents a novel approach to cancer immunotherapy, using RNA interference to selectively silence PD-1 expression at the tumor site without the systemic exposure typical of antibody therapies. If successful, the treatment could shift how early-stage skin cancers are managed, particularly in patients seeking alternatives to surgery or radiation.
The fourth cohort will mark the highest concentration of PH-762 administered to date, and upcoming data from that group—along with pending pathology results from cohort three—are expected to guide future clinical and regulatory strategies.
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