Phio Pharmaceuticals Corp. disclosed that its Phase 1b intratumoral PH‑762 study, which enrolled 22 patients across five dose‑escalation cohorts, achieved a 70 % overall pathologic response rate in cutaneous squamous cell carcinoma (cSCC). Ten patients attained complete clearance, two achieved near‑complete (>90 %) clearance, and two had partial (>50 %) clearance; a single patient with metastatic Merkel cell carcinoma also showed a partial response.
The 70 % response rate is the highest reported for an intratumoral therapy in this indication and is achieved without dose‑limiting toxicities or clinically relevant treatment‑emergent adverse events. PH‑762 was well tolerated as the dose was increased 20‑fold from the first to the final cohort, underscoring the safety profile that differentiates it from systemic PD‑1 inhibitors.
CEO Robert Bitterman highlighted the data as “remarkable” and noted that the company is now moving forward with the design of the next‑phase clinical trial and the required toxicology studies. The positive safety and efficacy profile supports Phio’s regulatory strategy to seek approval for PH‑762 and to expand the INTASYL® intratumoral platform into other solid tumors.
Phio’s financial position remains typical for a clinical‑stage biotech: a strong current ratio, ongoing cash burn, and a recent $13.4 million raise through warrant exercises. The trial results provide a critical data point that can strengthen investor confidence in the company’s pipeline and may influence future funding and partnership opportunities.
The announcement is expected to reinforce analysts’ view that PH‑762 has a compelling clinical profile, though the company’s valuation will still reflect the inherent risks of early‑stage development and the need for further data to confirm durability of response.
Future milestones include the release of extended safety data in Q2 2026 and the initiation of a pivotal trial, which will be pivotal for regulatory approval and potential commercialization.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.