Lytix Biopharma reports positive interim data from NeoLIPA study

Lytix Biopharma AS reported promising interim results from its ongoing Phase 2 NeoLIPA study for operable melanoma patients, showing a 44% pathological complete response (pCR) rate among the first nine evaluable patients out of thirteen enrolled. The combination treatment of ruxotemitide (formerly LTX-315) and pembrolizumab also demonstrated an 88% pathological response and a 55% major pathological response (MPR), with no patient relapses observed to date. The study, conducted at Oslo University Hospital – Radiumhospitalet, highlights ruxotemitide's dual mechanism of action in directly killing cancer cells and activating a systemic immune response.

These positive findings reinforce Lytix's confidence in ruxotemitide as a potential new treatment principle in immunotherapy, particularly for neoadjuvant settings. The company plans to accelerate its development strategy for neoadjuvant melanoma, combining ruxotemitide with a checkpoint inhibitor to streamline the path towards regulatory approval.

The NeoLIPA study (NCT 06651151) evaluates intratumoral ruxotemitide with pembrolizumab for Stage III–IV melanoma patients prior to surgical tumor removal. Key endpoints include safety profile, pathological response post-surgery (including pCR), and analysis of immunological responses.