Lytix Biopharma Announces Promising Interim Data on Neoadjuvant Treatment of Melanoma with Ruxotemitide from the NeoLIPA Study at the Norwegian Radium Hospital

11 Nov 2025 07:00 CET

Investigator-assessed pathologic complete response (pCR) observed in 44% of the
first nine evaluable patients (13 total enrolled) and with no relapses reported
to date.

Oslo, Norway, November 11, 2025 – Lytix Biopharma AS (“Lytix” or the “Company”)
today announced promising interim results from an ongoing investigator-initiated
Phase 2 NeoLIPA study evaluating ruxotemitide (formerly LTX-315) in combination
with pembrolizumab as neoadjuvant therapy in resectable melanoma.

Thirteen patients have been enrolled to date, and among the first nine evaluable
patients, the combination therapy has demonstrated:

• An overall pathological response of 88%.
• A major pathological complete response (MPR), meaning a significant reduction
in cancer cells, was achieved in 55% of patients.
• An even stronger pathological complete response (pCR), meaning no remaining
viable tumor cells, was achieved in 44% of patients.

Additionally, the treatment has a favorable safety profile, and no patient has
relapsed to date. The study is being conducted at Oslo University Hospital – The
Norwegian Radium Hospital.

These interim findings emphasize ruxotemitide’s unique intratumoral, immunogenic
cell-death mechanism, which alters the tumor microenvironment and triggers a
robust systemic anti-tumor immune response prior to surgery. Lytix Biopharma
remains highly encouraged by these findings, which demonstrate the potential of
ruxotemitide in this patient population.

“These very promising interim data in resectable melanoma treated in the
neoadjuvant setting are highly encouraging,” said Henrik Jespersen, MD,
Principal Investigator at Oslo University Hospital – The Norwegian Radium
Hospital. “The 44% pCR rate observed in the first nine evaluable patients and
with pathological responses in 8 out of 9 patients, combined with the favorable
safety profile and absence of relapses to date, represents a clinically
meaningful signal. Although the dataset is still maturing, these results support
further exploration of ruxotemitide as an innovative intratumoral approach to
enhance anti-tumor immunity before surgery.”

“The interim results from this neoadjuvant study in resectable melanoma, coupled
with our extensive body of clinical data from studies evaluating ruxotemitide
both as monotherapy and in combination with pembrolizumab, reinforce our
confidence in its potential,” said Øystein Rekdal, PhD, Founder and CEO of Lytix
Biopharma.

“The exciting results presented today, combined with the positive Phase II
results in resectable basal cell carcinoma recently presented by our partner
Verrica, indicate that the neoadjuvant setting is particularly well-suited for
ruxotemitide, where its unique mechanism of action can drive deeper and more
durable responses,” Rekdal continued. “With this solid foundation, we are
accelerating our development strategy in neoadjuvant melanoma with ruxotemitide
in combination with an immune checkpoint inhibitor to expedite the path toward
regulatory approval and ultimately deliver this transformative therapy to
patients.”

About the NeoLIPA Study (NCT 06651151)
The ongoing Phase 2, investigator-initiated NeoLIPA trial evaluates intratumoral
administration of ruxotemitide in combination with pembrolizumab administered
prior to surgical resection in patients with resectable stage III-IV melanoma.
Key endpoints include safety and feasibility, pathologic response at surgery
(including pCR), and exploratory immunologic readouts.

Next Steps
Building on these positive results and our wider clinical insights, Lytix is
strategically accelerating the development of ruxotemitide in the neoadjuvant
melanoma setting, focusing on the most efficient route to regulatory approvals.

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.

For more information, please contact:
Keith Bowermaster, APR, CCMP
Mighty Spark Communications
kbowermaster@mightysparkcommunications.com

About Lytix:
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.
For more information, visit www.lytixbiopharma.com.

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659271_NeoLIPA Interim Data - Press release - Final.pdf