Lytix Biopharma's LTX-315 Enters Phase II Trial for Early-Stage Melanoma

• Lytix Biopharma initiates a Phase II trial (NeoLIPA) to assess LTX-315 combined with pembrolizumab in early-stage melanoma patients, addressing a substantial market expected to reach $11 billion by 2030.
• The NeoLIPA trial, led by Oslo University Hospital, aims to enroll 27 patients and will evaluate the pathologic complete response rate, with interim results expected in H2 2025.
• LTX-315's dual mechanism—killing cancer cells locally and activating systemic immunity—positions it as a promising combination agent with standard immunotherapy to prevent disease recurrence.
• This trial expands Lytix Biopharma's clinical program, building on promising results in late-stage melanoma and basal cell carcinoma, to address the unmet need for more effective early-stage melanoma treatments.

Lytix Biopharma has announced the treatment of the first patient in its Phase II NeoLIPA trial, evaluating LTX-315 in combination with pembrolizumab for early-stage melanoma. The trial, led by Oslo University Hospital (Radiumhospitalet), aims to improve outcomes for patients who often experience disease recurrence even after surgical removal. This study could potentially address a significant unmet need in the melanoma treatment landscape, which is projected to reach an $11 billion market by 2030.

NeoLIPA Trial Details

The NeoLIPA trial will enroll approximately 27 patients diagnosed with early-stage melanoma. Participants will receive LTX-315 in conjunction with pembrolizumab, a standard-of-care PD-1 inhibitor, prior to surgical removal of melanoma lesions. The primary endpoint is the pathologic complete response (pCR) rate, defined as the absence of cancer cells in tissue samples post-surgery. Secondary endpoints include time to recurrence and overall survival. Interim results are anticipated in the second half of 2025.

LTX-315 Mechanism and Rationale

LTX-315 is a first-in-class oncolytic molecule designed to enhance anti-cancer immunity. It functions by directly killing cancer cells at the site of injection and activating the immune system to target cancer cells throughout the body. According to Dr. Henrik Jespersen, Head of Melanoma at Oslo University Hospital, LTX-315 addresses some of the shortcomings of PD-1 inhibitors, making the combination with pembrolizumab a potentially synergistic approach. The neoadjuvant setting allows for early intervention before surgical removal, potentially preventing disease recurrence.

Market and Clinical Context

Melanoma incidence is rising globally, affecting over 300,000 new patients annually. Despite advancements in treatment, recurrence remains a significant challenge. The combination of LTX-315 with pembrolizumab aims to improve the pCR rate and reduce recurrence, offering a potential advantage over current treatments. Dr. Øystein Rekdal, CEO of Lytix Biopharma, emphasized that early-stage melanoma patients often have a more robust immune system, potentially increasing the likelihood of a positive response to LTX-315.

Ongoing Clinical Programs

Lytix Biopharma currently has three ongoing Phase II studies. Besides the NeoLIPA trial, LTX-315 is being evaluated in late-stage melanoma patients (ATLAS-IT-05) and in patients with basal cell carcinoma in the US through a partnership with Verrica Pharmaceuticals. These trials underscore Lytix Biopharma's commitment to developing novel immuno-oncology therapies across various cancer indications.