Lytix Biopharma Reports Phase II Data in Melanoma and Triple-Negative Breast Cancer for Ruxotemitide (LTX-315) in Combination with Pembrolizumab

01 Jun 2026 07:05 CEST

Oslo, Norway, 1 June 2026 - Lytix Biopharma ASA ("Lytix" or the "Company"), a
clinical-stage immuno-oncology company developing novel intratumoral cancer
therapies, today announced that clinical data evaluating intratumoral
ruxotemitide (LTX-315) in combination with pembrolizumab in patients with
advanced melanoma and metastatic triple-negative breast cancer (TNBC) has been
presented in a poster session at the 2026 American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago, Illinois, USA.

The poster, entitled "Safety and Efficacy of Intratumoral (IT) Ruxotemitide
(LTX-315) in Combination with Pembrolizumab in Patients with Unresectable
Advanced Melanoma or Triple Negative Breast Cancer (TNBC)," presents pooled data
from two open-label Phase II studies of intratumoral ruxotemitide plus
pembrolizumab in patients with advanced melanoma who had progressed following
prior anti PD-1/PD-L1 therapy and in patients with metastatic TNBC.

Key efficacy observations from the pooled analysis include:
• Antitumor activity was observed in heavily pretreated patients with advanced
melanoma and metastatic TNBC, two populations with limited therapeutic options.
• Durable responses was obtained in melanoma patients in the context of prior
PD-1/PD-L1-refractory disease.
• Systemic activity was noted, including tumor regression in non-injected
lesions, supporting the potential of ruxotemitide to induce broader immune
activation following local intratumoral administration.
• The safety profile observed across the studies was broadly consistent with the
known effects of intratumoral immunotherapy and pembrolizumab, and the
combination was manageable.

The poster was presented by Prof. Aurélien Marabelle of Gustave Roussy, France,
a senior clinical investigator in cancer immunotherapy with dedicated expertise
in intratumoral treatment approaches. Prof. Marabelle leads clinical and
translational work focused on immune-targeted therapies and intratumoral
immunotherapy and serves on the Board of Directors of the Society for
Immunotherapy of Cancer (SITC).

“The pooled Phase II data show that intratumoral ruxotemitide in combination
with pembrolizumab was generally manageable and demonstrated antitumor activity
in two difficult-to-treat patient populations: advanced melanoma after prior
anti-PD-1/PD-L1 therapy and metastatic triple-negative breast cancer,” said
Prof. Aurélien Marabelle of Gustave Roussy, France. “The observation of durable
responses in melanoma, disease stabilization across both studies and activity in
non-injected lesions supports further clinical evaluation of this intratumoral
immunotherapy approach, including in earlier treatment settings.”

“These Phase II data represent an important step in building the clinical
rationale for ruxotemitide as a differentiated intratumoral immunotherapy,” said
Øystein Rekdal, Chief Executive Officer of Lytix Biopharma. “Our ambition is to
use local tumor destruction to initiate broader systemic antitumor immunity and
thereby improve the depth and durability of responses to checkpoint inhibition.
The ASCO findings strengthen our conviction that ruxotemitide should be advanced
into earlier treatment settings, where immune activation may have the greatest
potential to change patient outcomes.”

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-associated molecular 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 more information, visit www.lytixbiopharma.com.

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