Encouraging preliminary data from Lytix Biopharma’s ATLAS-IT-05 study presented at ESMO 2023

Oslo, 23 October 2023. Lytix Biopharma – Lytix Biopharma AS (“Lytix”) (Euronext Growth Oslo: LYTIX), a clinical stage immuno-oncology company, announces that Dr Stephane Dalle, the top recruiting investigator of the ATLAS-IT-05 study, will give a poster presentation today at the ESMO 2023 Congress.

ATLAS-IT-05 is a Phase II open label clinical trial with LTX-315 in combination with Keytruda® (pembrolizumab) in stage III-IV melanoma patients refractory to treatment with PD-1 / PD-L1 inhibitors.  

The poster presents early preliminary clinical data from 20 patients (14 patients for efficacy) with advanced melanoma who have failed a checkpoint inhibitor and have a poor prognosis. Most of the enrolled patients have failed on several lines of treatment, including combined checkpoints or BRAF/MEK inhibition. The results are based on an early read out from the study with a median follow-up of 15 weeks.   

The combination with LTX-315 and pembrolizumab demonstrates prolonged stabilization in this heavily pre-treated patient population with a disease control rate of 43% and at this early time point showing one patient achieving a partial response. Almost half of the patients are continuing on the trial.

Some patients have shown impressive evidence of significant tumor shrinkage in both injected and non-injected lesions, and LTX-315 was well-tolerated with general mild to moderate treatment related adverse events.

The trial is currently ongoing, and the interim data are considered immature – further details will be shared in a future presentation. The patients are still early in the treatment course, and conclusions drawn from this interim report could change over time. 

Dr. Øystein Rekdal, Chief Executive Officer at Lytix Biopharma, commented:

”Even though these data are early, we are encouraged by the promising signs of efficacy seen so far.  We are looking forward to seeing the results from the full cohort of patients enrolled in the study, followed over a longer time period. We expect to report top line data from 20 patients in Q1 2024. We are also in the process of submitting an amendment for the initiation of an expansion cohort with up to 20 additional patients.”

Details for the poster session are as follows:

Poster Title: 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

Presenter: Stephane Dalle

Poster Number:  1051P

Session: Investigational immunotherapy

Session Date and Time: Monday, October 23, 2023

Session Location: Hall 8

The poster and webcast presentation are available on Lytix’s website; https://www.lytixbiopharma.com

Webcast and Q&A

Øystein Rekdal, Chief Executive Officer, and Graeme Currie, Chief Development Officer, will host a webcast for investors and analysts today at 15.30 CEST.

The webcast and subsequent Q&A session will be held in English and may be viewed live by registering here: https://forms.office.com/e/aiR9KtDQKL

For more information, please contact:

Gjest Breistein, CFO: gjest.breistein@lytixbiopharma.com
Ole Peter Nordby, Head of IR & Communications Manager: ole.peter.nordby@lytixbiopharma.com
Optimum Strategic Communications: Jonathan Edwards, Vici Rabbetts: lytix@optimumcomms.com

Lytix in brief:

Based in Oslo, Norway, Lytix Biopharma is a clinical stage immuno-oncology company developing novel cancer immunotherapies, an area within cancer therapy that is aimed at activating the patient’s immune system to fight cancer. The Company’s technology is based on pioneering research in “host defense peptides” – nature’s first line of defense towards foreign pathogens. Lytix Biopharma’s lead product, LTX-315, is a first-in-class molecule representing a new and superior therapeutic principle to kill cancer cells and boost anti-cancer immunity, with the potential to be the ideal combination partner with other types of immunotherapy. LTX-315 targets cancer cells and disintegrates their cell membranes, causing immunogenic cell death and release of a patient’s tumor specific antigens.  This mode of action allows cytotoxic T cells to recognize, infiltrate, and attack cancer cells. The Company was listed on Euronext Growth in Oslo in June 2021, following a private placement covered by investors including PBM Capital, a US based, healthcare-focused investment firm.