Clinical-stage cell therapy company Chimeric Therapeutics (ASX:CHM) says that it has successfully completed a pre-Investigational New Drug (pre-IND) meeting with the US FDA and has received "positive feedback" on the development plan for CHM 2101.
The company described this as a significant milestone towards an IND application and Phase 1 clinical trial for CHM 2101.
It said it received positive written responses from the FDA that provide a clear path to an IND submission for CHM 2101 and validates the team’s efforts and accomplishments in preparing CHM 2101 for clinic.
“The positive feedback we received from the FDA was encouraging and aligns clearly with our development plan for CHM 2101,” said CEO and managing director Jennifer Chow.
“We are highly appreciative of the FDA’s support and guidance as this brings us closer to potentially transforming the lives of patients with gastrointestinal and neuroendocrine tumours.”
CHM 2101 is a first-in-class third-generation autologous CAR-T cell therapy. Chimeric said it is focused on advancing CHM 2101 towards a phase 1A clinical trial in gastrointestinal and neuroendocrine tumours.