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

28 Aug 2023 13:48 CEST

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.

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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”.

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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.

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“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.

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For more information, please contact:
* Gjest Breistein, CFO: gjest.breistein@lytixbiopharma.com
* Ole Peter Nordby, Head of IR & Communication 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 target cancer cells and disintegrate 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 such as
PBM Capital, a US based, healthcare-focused investment firm.

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