Lytix Biopharma AS announces that LTX-315 with Adoptive Cell Therapy has been shown to generate tumor-specific T cells and stabilize the disease in patients with metastatic soft tissue sarcoma (STS).

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 progressive 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.