Lytix Biopharma announced that the Norwegian Medical Products Agency has approved the clinical trial application for a Phase II Neoadjuvant study in early-stage melanoma, a severe form of skin cancer. In this study, Lytix's lead candidate LTX-315 will be given in combination with another type of immunotherapy before surgery. The study is called NeoLIPA and will be led by Dr. Henrik Jespersen, Head of melanoma Oncology at Radiumhospitalet (Oslo University Hospital).

Melanoma is the fastest growing cancer in large parts of Europe and North America. The increase is often attributed to increased exposure to ultraviolet radiation because of changed sun habits. The Oslo University Hospital plan to start recruiting patients before the summer.

The neoadjuvant study will be a Phase II, open-label study recruiting 27 patients with clinically detectable and resectable stage III-IV melanoma. Following the start-up in Oslo, Lytix Biopharma will have a portfolio of three ongoing phase II studies. Expanding from late-stage patients: Lytix has previously announced positive interim results from the ongoing Phase II study in late-stage and heavily pre-treated patients (ATLAS-IT-05).

Introducing LTX-315 to early-stage patients with less advanced disease and stronger immune system could represent a significant commercial opportunity, as this patient population is much larger and neoadjuvant therapy is becoming standard of care. The study will be an investigator-led study. Hence, specific to Lytix Biopharma, the cost exposure is mostly limited to drug supply.

Multiple studies: Including the NeoLIPA study in Oslo, Lytix's lead candidates LTX-315 is tested in currently tested in three different phase II studies; One with its licensing partner Verrica Pharmaceuticals in the US in patients with the most common type of skin cancer (basal cell carcinoma) and one in late-stage melanoma patients.