Cartherics successfully completes a pre-investigational new drug meeting with the US FDA

Cartherics, a biotechnology company developing immune cell therapies for the treatment of cancer, have announced 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.