Cartherics completes successful pre-IND meeting with US FDA

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Cartherics says it has completed a pre-investigational new drug (pre-IND) meeting with the US 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.

The company said this represents a significant milestone towards filing an IND application for CTH-401.

It said it received positive feedback on its development plan for CTH-401 that provides a clear path towards filing an IND, and validates its approach to the creation and development of CTH-401.

Cartherics CEO Professor Alan Trounson AO said, “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 said it 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.