Oslo, Norway, June 5th, 2022 - Lytix Biopharma AS ("Lytix" or the "Company"), a
clinical-stage company with an in situ vaccination technology platform, today
announces data from its ATLAS-IT-04 trial in patients with metastatic soft
tissue sarcoma (STS). The data from this Phase II proof of concept study shows
that LTX-315 in combination with Adoptive Cell Therapy (ACT) was able to
stabilize the disease in 3 out of 4 fully treated patients in this hard-to-treat
patient population, and that the LTX-315 treatment generated tumor-specific T
cells. 

The data is presented June 5th, 2022, as a poster at the American Society of
Clinical Oncology (ASCO) 2022 Annual Meeting, Chicago, IL, U.S.A.

The ATLAS-IT-04 trial was an open label, exploratory, Phase II trial assessing
the effect of LTX-315 when used in combination with ACT in patients with
metastatic STS. ACT with tumor infiltrating lymphocytes (TILs) is a potent
treatment that can induce complete and durable tumor regression as documented in
patients with melanoma. The use of ACT with TILs for patients with advanced STS
has not previously been reported.

Patients with advanced stages of STS have few effective treatment options and
respond poorly to current treatment as well as to immunotherapy tested in
clinical trials. The trial design of ATLAS-IT-04 included intratumoral
injections of LTX-315 ahead of surgical removal of tumors, followed by in vitro
expansion of T cells as the first step. In a second step, the expanded T cells
were infused back to the patients and the effect of LTX-315 on the tumor
microenvironment was assessed. 

LTX-315 is a first-in-class non-viral oncolytic molecule, representing a new and
superior in situ therapeutic vaccination principle to boost the clonal expansion
of T cells that kill tumor cells through a targeted immune response. In a recent
Phase I/II study LTX-315 has been shown to increase TILs in malignant solid
tumors after intratumoral injection. 

The immune response data from the ATLAS-IT-04 trial demonstrates that the
treatment induce both new and tumor-specific T cells which provides proof to the
concept that LTX-315 generates an immune response that targets the tumor.
Moreover, the data shows that LTX-315 induce expansion of a heterogenous pool of
T-cell clones in blood, and a pool of these are also present in tumor tissue
after treatment.

"This trial demonstrates that the combination of LTX-315 and ACT is not only
feasible and tolerable, but that tumor-specific T cells can be expanded in vitro
from tumors that have been pretreated with the oncolytic molecule LTX-315", Inge
Marie Svane, PI and Professor at the National Center for Cancer Immune Therapy,
Department of Oncology, Copenhagen University Hospital, comments. 

She adds: "This combination therapy invokes tumor specific T cells that can be
cultured and infused as part of an adoptive transfer regimen for several
subtypes of soft tissue sarcoma, and its treatment schedule should be further
optimized to achieve superior signs of efficacy."

The poster is presented June 5th at the ASCO 2022 Annual Meeting.
Poster Session: Sarcoma
Abstract: 11567
Poster: 471

The poster can be found here
https://www.lytixbiopharma.com/research-development/posters.html

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 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.