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Positive Pre-IND Meeting With US FDA For New Ovarian Cancer Cell Therapy

Melbourne, Australia, 1 February 2024 – Cartherics Pty Ltd (“Cartherics” or “Company”), a biotechnology company developing immune cell therapies for the treatment of cancer, is pleased to announce that it has successfully completed a pre-investigational new drug (pre-IND) meeting with the US Food and Drug Administration (FDA) for a Phase I/II clinical trial of its lead “off-the-shelf” natural killer (NK) cell therapy product, CTH-401 for the treatment of ovarian cancer.

This is a significant milestone towards the filing of an Investigational New Drug (IND) application for CTH-401.The purpose of the meeting was to gain valuable guidance from the FDA on activities that need to be completed prior to submitting an IND application, particularly supporting non-clinical studies.

Cartherics received positive feedback on its development plan for CTH-401 that provides a clear path towards filing an IND and validates the Company’s approach to the creation and development of CTH-401.

Cartherics CEO, Prof Alan Trounson AO, commented: “The pre-IND meeting for CTH-401 was a significant milestone for Cartherics and, based on the FDA’s guidance, we are confident that we’re on the path to a successful IND submission in early 2025.”

CTH-401 is the only NK cell product currently under development that incorporates a chimeric antigen receptor (CAR) that targets the adenocarcinoma specific antigen,TAG-72. TAG-72 is a well-validated tumour marker that is widely expressed in a range of solid tumours, including ovarian, gastric, colorectal, prostate and pancreatic cancers. Cartherics has demonstrated that CTH-401 is very effective in killing ovarian cancer cells in both tissue culture and animal models, with initiation of the first clinical trial planned for early 2025.

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About Cartherics

Cartherics is a privately held biotechnology company based in Melbourne, Australia that is rearming the body’s immune system to fight cancer. It is developing cell-based immunotherapies for the treatment of cancer, with a portfolio of CAR-T and CAR-NK cell products. The Company’s allogeneic (“off-the-shelf”) cell platform is based upon induced pluripotent stem cells (iPSCs) generated from donated cord blood that can be differentiated into NK cells, T cells and other cells of the immune system. The iPSCs are genetically engineered at specific “safe harbour” genomic sites to provide enhanced function for the derived NK and other immune cells.

The Company is also developing autologous CAR-T cell therapies. These use the patient’s own immune system T cells, which are modified to be effective against the patient’s cancer cells. CTH-004 is created by genetically modifying patient T cells to insert a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes that are involved in suppression of T cell function. https://cartherics.com/

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