Dec 8, 2021
Lytix Biopharma Announces that First Patient Started Treatment in the ATLAS-IT-05 clinical trial
Lytix Biopharma AS announces that the first patient has started treatment in the clinical Phase II combination trial evaluating intratumoral injection of Lytix’ lead drug candidate, LTX-315.



“Treating our first patient at MD Anderson marks an important milestone for Lytix. We are confident that Lytix’ unique technology offers a solution to today’s cancer treatment challenges, through activation of the body’s own immune system. The results from the study will help us understand the contribution of LTX-315 and the path towards the market”, said Dr. Øystein Rekdal, CEO at Lytix Biopharma.



Lytix Biopharma’s lead drug candidate will be studied in combination with the immune checkpoint inhibitor pembrolizumab (Merck’s anti-PD-1 therapy, KEYTRUDA®) in patients with solid tumors. The first patient is enrolled at MD Anderson Cancer Center in Houston, Texas. MD Anderson is one of the world’s leading cancer hospitals, and also the hospital where Nobel Prize winner Dr. Jim Allison works as a professor and chair of the department of immunology. Dr. Allison holds a position on Lytix Biopharma’s advisory board.

Earlier this year, Lytix Biopharma received an approval from the FDA to run a multicenter Phase II study in the US, and now the first patient is recruited into that study. As an oncolytic molecule, LTX-315 is designed specifically for intratumoral injection, resulting in immediate immunogenic cell death of cancer cells. This in situ vaccination technology activates the patient’s immune system to fight cancer.

LTX-315 will be evaluated 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.



“We see a strong mechanistic rationale to explore the combination and sequence of LTX-315 and an immune checkpoint inhibitor. These data 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”, Dr. Rekdal states. “Verrica Pharmaceuticals just announcing its progress towards a Phase II study in the US with LTX-315 for the treatment of basal cell carcinoma, means that LTX-315 will be in two separate and independent Phase II studies in US in the first quarter of 2022.”



The clinical trial ATLAS-IT-05 is designed to assess the efficacy of LTX-315 in several types of solid tumors. The trial will be a multicenter study including MD Anderson Cancer Center in Texas.

Enrolled patients will receive treatment with LTX-315 for up to 5 weeks. Pembrolizumab therapy will last until progression or 24 months after enrollment. More information about the trial is available at www.clinicaltrials.gov.