Lytix Biopharma has announced the treatment of the first patient in its Phase II NeoLIPA clinical trial at Radiumhospitalet in Oslo, Norway. The trial is designed to evaluate the efficacy of LTX-315, Lytix's lead drug candidate, in combination with pembrolizumab, for patients with early-stage melanoma.
The investigator-led trial, conducted by Oslo University Hospital, aims to enroll approximately 27 patients. The combination therapy involves administering LTX-315 along with pembrolizumab to patients before surgical removal of their melanoma lesions. Interim results from the NeoLIPA trial are anticipated in the second half of 2025.
Rationale for Combination Therapy
The rationale behind combining LTX-315 with pembrolizumab lies in LTX-315's unique mechanism of action. According to Dr. Henrik Jespersen, Head of Melanoma at Oslo University Hospital, LTX-315 can both directly kill cancer cells and activate the immune system to target cancer cells elsewhere in the body. This dual action may complement the effects of pembrolizumab, a PD-1 inhibitor that enhances the immune system's ability to attack cancer cells.
Study Objectives and Endpoints
The primary endpoint of the NeoLIPA trial is the pathologic complete response (pCR) rate, defined as the complete absence of cancer cells in tissue samples removed during surgery. Secondary endpoints include time to recurrence and overall survival. The study aims to determine whether the combined neoadjuvant treatment of LTX-315 and pembrolizumab improves the pCR rate and reduces the risk of melanoma recurrence.
Melanoma Treatment Landscape and Market
Melanoma is a severe form of skin cancer with a rising global incidence. Despite advancements in treatment, many patients experience disease recurrence even after surgical removal of lesions. This highlights the need for new and more effective therapies for early-stage melanoma.
The market for melanoma treatment is substantial and growing, with projections estimating a global market size of USD 11 billion by 2030, reflecting an annual growth rate exceeding 10%. The increasing number of new melanoma cases each year underscores the importance of developing innovative treatment strategies.
LTX-315: A Novel Oncolytic Molecule
LTX-315 is a first-in-class oncolytic molecule developed by Lytix Biopharma. It represents a novel approach to boosting anti-cancer immunity. Lytix Biopharma has a pipeline of molecules that can work in various cancer indications and treatment settings, both as monotherapy and in combination with other treatments.
According to Dr. Øystein Rekdal, CEO of Lytix Biopharma, expanding clinical trials to early-stage melanoma patients adds to the company's robust portfolio of clinical studies and represents a vast commercial potential. The company believes that LTX-315 may offer important advantages for this patient population, potentially preventing disease recurrence compared to current treatments.
