Lytix Biopharma announces completion of patient recruitment in the ATLAS-IT-05 trial

Oslo, 28 August 2023. Lytix Biopharma – Lytix Biopharma AS (“Lytix”) (Euronext Growth Oslo: LYTIX), a clinical stage immuno-oncology company, announces that it has completed recruitment of 20 patients in the ATLAS-IT-05 trial - a trial evaluating LTX-315, Lytix’ lead drug candidate.

The ATLAS-IT-05 trial is designed to assess the efficacy of LTX-315 in patients with advanced melanoma, who are refractory to treatment with anti-PD-1/PD-L1 inhibitors. LTX-315 is being studied in combination with the immune checkpoint inhibitor pembrolizumab, which blocks tumor cells’ ability to prevent the body’s immune response. Results from earlier studies indicate that the combination of LTX-315 and pembrolizumab may work better than pembrolizumab alone.

Dr. Øystein Rekdal, CEO at Lytix Biopharma, commented: “We are confident that Lytix’ unique technology offers a solution to today’s cancer treatment challenges, through the direct killing of cancer cells and a broad activation of the body’s own immune system. The results from the study will help us understand the contribution of LTX-315 to the clinical response among patients and help us to advance LTX-315 further towards the market”.

The first patient in this trial was enrolled in December 2021, at MD Anderson Cancer Center in Houston, Texas - one of the world’s leading cancer hospitals.  A total of 10 sites have been involved in this study   - 4 in the US and 6 in Europe.

Enrolled patients receive treatment with LTX-315 for up to 5 weeks. Pembrolizumab therapy will continue until disease progression or 24 months after enrollment. (More information about the trial is available at https://clinicaltrials.gov/study/NCT04796194.)

The first interim results from the trial will be presented by the top recruiting investigator, Professor Stéphane Dalle (Centre Hospitalier Universitaire de Lyon, France), in a poster session at ESMO, taking place in Madrid, Spain, 20-24 October 2023. The poster title is: Intratumoral injection of LTX-315 in combination with pembrolizumab in patients with advanced melanoma refractory to prior PD-1/PD-L1 therapy: interim results from the ATLAS-IT-05 trial.

“We see a strong mechanistic rationale to explore the combination and treatment sequence of LTX-315 and an immune checkpoint inhibitor. Data from the ATLAS-IT-05 trial will help us understand the potential of LTX-315 to improve durability and response rates of patients treated in combination with existing immuno-oncology drugs. We look forward to presenting the first interim results of this trial at ESMO in October”, Dr. Graeme Currie, CDO in Lytix Biopharma, commented.