This marks a ‘significant milestone’ towards the filing of an Investigational New Drug (IND) application for CTH-401, the company said.
The purpose of the meeting was to gain 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.
Professor Alan Trounson, CEO of Cartherics, 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 tumor marker that is widely expressed in a range of solid tumours, including ovarian, gastric, colorectal, prostate and pancreatic cancers.
According to Cartherics, 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.
