Lytix Biopharma AS Announces that First Patient Started Treatment in the ATLAS-IT-05 clinical trial

08 Dec 2021 08:00 CET

Oslo, Norway, December 8, 2021 – Lytix Biopharma AS, a clinical-stage company
with an in situ vaccination technology platform, 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.

For further information please contact:
Øystein Rekdal (CEO),
Telephone: +47 975 73 358
E-mail: Oystein.Rekdal@lytixbiopharma.com


Lytix Biopharma in brief
Based in Oslo, Norway, Lytix Biopharma 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
in situ therapeutic vaccination principle to 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 such as
PBM Capital, a US based, healthcare-focused investment firm.

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