The immunological analyses from Verrica’s Phase II study in basal cell carcinoma (BCC) demonstrated strong increases in cytotoxic CD8⁺ and helper CD4⁺ T cells, as well as B-cell infiltration, alongside a marked reduction in immunosuppressive T-regulatory cells in the tumor microenvironment. In Verrica’s Phase II BCC study, ruxotemitide achieved 97% calculated objective response rate, 51% complete histologic clearance rate, and well-tolerated safety profile.

The findings provide compelling evidence that ruxotemitide, a first-in-class oncolytic peptide immunotherapy, reprograms the tumor microenvironment from an immune-suppressed “cold” tumor microenvironment to an immune-activated state, describes the company. The results further substantiate ruxotemitide’s two-step mode of action: direct tumor cell disruption with release of tumor antigens and danger signals, and subsequent immune activation, converting “cold or immunosuppressed” tumors into “hot,” immune-responsive lesions.

“These results illustrate how ruxotemitide can transform immune-suppressed tumors into immune-active ones,” says Øystein Rekdal, CEO of Lytix Biopharma. “The SITC data further validate the strength of our oncolytic molecule-based immunotherapy platform and reinforce our confidence in its potential across multiple solid tumor types. Whereas ruxotemitide was used as monotherapy in Verrica’s phase II study in BCC, its direct oncolysis combined with local immune activation also creates a tumor environment primed for potential combinations  in other tumor types.”

A potential abscopal-like immune effect was observed with histologic reduction in size of all non-treated BCC lesions studied, consistent with the systemic immune activation properties of ruxotemitide observed in other cancer models.

Verrica is currently evaluating plans to advance ruxotemitide into a pivotal Phase III program in BCC, while Lytix Biopharma continues its broader oncology development, including the NeoLIPA Phase II study in melanoma, where interim results will be presented at the Nordic Melanoma Meeting in Tromsø on November 11, 2025.