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

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.