LYTIX: FDA Feedback Clears Path to Registrational Phase III Trial for Ruxotemitide (LTX-315) in Patients with Resectable High-Risk Melanoma
2026-08-27 06:55:00
Oslo, Norway, August 27, 2026 - Lytix Biopharma ASA ("Lytix" or the "Company"),
a clinical-stage immuno-oncology company developing novel intratumoral cancer
therapies, today announced feedback from its July meeting with the U.S. Food and
Drug Administration (FDA) on the planned registrational trial of ruxotemitide
(LTX-315) in combination with pembrolizumab in high-risk resectable melanoma.
The FDA raised no objection to Lytix's proposed randomized Phase III trial of
neoadjuvant ruxotemitide plus pembrolizumab versus pembrolizumab alone, with
event-free survival (EFS) as the primary endpoint. The FDA also confirmed that a
single well-controlled trial may support a New Drug Application, depending on
the totality of the data generated.
The FDA feedback follows previously reported interim data from NeoLIPA, an
ongoing investigator-initiated Phase 2 study of neoadjuvant ruxotemitide in
combination with pembrolizumab. Among the first 9 evaluable patients, 88%
achieved an overall pathological response, including 55% with a major
pathological response and 44% with a complete pathological response, with no
relapses reported at the time of the analysis. Top-line results are expected in
the second half of 2026.
"This constructive feedback from the FDA on our registrational study design
removes a key source of uncertainty as we look toward a registrational trial. I
want to thank our clinical, regulatory, and scientific teams for the work that
went into this program over many years," Øystein Rekdal, Ph.D., CEO of Lytix,
commented.
Lytix will continue preparations for the registrational study within its
existing capital-efficient plan, and recently appointed Timothy F. Herpin,
Ph.D., M.B.A., as Chief Business Officer on a fractional basis to lead
partnership discussions. "With a defined regulatory pathway and a well-supported
combination approach with pembrolizumab now in hand, we are well positioned to
actively pursue partnerships to fund and execute the study and evaluate
alternative options to advance the program," added Rekdal.
About Ruxotemitide (LTX-315)
Ruxotemitide (LTX-315) is a first-in-class oncolytic peptide designed for
intratumoral administration. The molecule disrupts tumor cells locally, leading
to the release of tumor antigens and danger signals that may activate systemic
antitumor immune responses. This mechanism has the potential to convert
immunologically "cold" tumors into "hot" tumors and enhance responses to
checkpoint inhibitor 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 monotherapy and in combination
therapy. Lytix is listed on Euronext Growth Oslo under the ticker LYTIX.
For further information, please contact:
Gjest Breistein, CFO
gjest.breistein@lytixbiopharma.com
+47 952 60 512
ase contact:\
Gjest Breistein\, CFO\
gjest.breistein@lytixbiopharma.com\
+47 952 60 512\