Oslo, 7 September 2022. Lytix Biopharma ("Lytix") (Euronext Growth Oslo: LYTIX),
a Norwegian immuno-oncology company, today announces the regulatory approval
from European authorities to commence the ATLAS-IT-05 study in three European
countries.

ATLAS-IT-05 is a Phase II combination study evaluating LTX-315 and pembrolizumab
in patients with advanced melanoma. The study was initiated at MD Anderson
Cancer Center in 2021 and is currently ongoing in the US. The objective of the
study is to document whether LTX-315 in combination with pembrolizumab is
effective in inducing responses in patients who have failed prior anti PD 1/PD
L1 immune checkpoint therapy. 

The clinical trial application (CTA) has now been approved according to the
European Clinical Trial Regulation, and the national authorities in Spain,
France and Norway have commended the CTA for ATLAS-IT-05. 
The approval will enable the expansion of the site network and clinical impact
field for LTX-315, mitigate recruitment challenges and drive enrollment in the
ATLAS-IT-05 Phase II trial towards completion. The study will be performed at
highly recognized sites with intratumoral immunotherapy expertise in the three
European countries. It will be led by melanoma experts at each site and follow
the same protocol as in the US. 

The regulatory application in Europe was submitted in Q2 2022 and six leading
clinical sites in Europe are expected to open during the 4th quarter of 2022.
Efforts to prepare the sites for initiation of the study and recruitment of
patients is ongoing with the aim to complete enrollment in the study in early
2023.


"We are very pleased to have received the regulatory approval to commence
studies in three European countries. Lytix has mobilized internal resources and
moved extraordinary fast in the face of the need to broaden the impact of this
study among clinicians and key opinion leaders. The speed with which we were
able to move from the start of this expansion program to this approval speaks to
the high level of engagement from the team at Lytix. Now that the European
approval has been granted, we are looking forward to and actively preparing for
the upcoming start of this clinical study at the European sites," says CEO and
Co-founder of Lytix Biopharma, Øystein Rekdal.


For more information, please contact: 
Ole Peter Nordby, ole.peter.nordby@lytixbiopharma.com

Lytix Biopharma in brief: 
Based in Oslo, Norway, Lytix is a clinical stage biotech 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 oncolytic molecule representing a new and superior
therapeutic principle to boost anti-cancer immunity, with the potential to be
the ideal combination partner with other types of immunotherapies. LTX-315
targets cancer cells and disintegrates their cell membranes, causing immunogenic
cell death and release of a patient's tumor specific antigens and potent
immunostimulants. This mode of action allows cytotoxic T cells to recognize,
infiltrate and attack cancer cells.