New Phase II Study Data from Lytix Biopharma’s Partner Presented at SITC 2025 Further Validate Unique Immune-Activating Mechanism of Ruxotemitide

10 Nov 2025 07:00 CET

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
kbowermaster@mightysparkcommunications.com

More information:
Access the news on Oslo Bors NewsWeb site

659147_Lytix SITC Press Release FINAL.pdf
659147_SITC 2025 - Poster - Ruxotemitide (VP-315) Basal Cell Carcinoma.pdf