New Phase II Study Data from Lytix Biopharma’s Partner Presented at SITC 2025 Further Validate Unique Immune-Activating Mechanism of Ruxotemitide
New Phase II Study Data from Lytix Biopharma’s Partner Presented at SITC 2025 Further Validate Unique Immune-Activating Mechanism of Ruxotemitide
Oslo, Norway, November 10, 2025 – Lytix Biopharma AS (“Lytix” or the “Company”) today announced that new immune response data on ruxotemitide (formerly LTX-315/VP-315) were presented on behalf of Verrica Pharmaceuticals at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Maryland.
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
• 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. The results further substantiate ruxotemitide’s unique two-step mode of action:
1. Direct tumor cell disruption with release of tumor antigens and danger signals.
2. 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,” said Øystein Rekdal, PhD, 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.
About ruxotemitide
Ruxotemitide is an investigational, first-in-class, oncolytic immunotherapy administered intratumorally, to disrupt tumor cell membranes, release tumor antigens, and activate local and systemic anti-tumor immune responses irrespective of tumor heterogeneity or PD-L1 status. Ruxotemitide is being studied in various tumor settings, including as a neoadjuvant therapy in resectable solid tumors, both as a monotherapy and in combination therapies.
About Lytix Biopharma
Based in Oslo, Norway, Lytix Biopharma is a clinical-stage biotech company with a highly differentiated oncolytic molecule platform based on world-leading research in host-defense peptide-derived molecules. Lytix Biopharma’s lead product, ruxotemitide (formerly LTX-315), is a first-in-class oncolytic molecule representing a new approach to maintaining durable anti-cancer immunity. Lytix Biopharma has a pipeline of molecules that work across multiple cancer indications and treatment settings, both as mono- and combination therapy. Lytix is listed on Euronext Growth Oslo under the ticker LYTIX.
Visit www.lytixbiopharma.com.
For further information, please contact:
Keith Bowermaster, APR, CCMP
Mighty Spark Communications
[email protected]