Chimeric Therapeutics Ltd (ASX:CHM) has met with the US Food and Drug Administration (FDA) regarding its proposed Phase 1 clinical trial featuring its asset CHM 2101 in the treatment of gastrointestinal and neuroendocrine tumours.
The pre-investigational new drug (pre-IND) meeting represents a significant milestone in the development pathway for CHM 2101, as the FDA’s feedback and advice supports Chimeric’s planned Phase 1 clinical trial and technical operations strategy.
Positive guidance
The objective of the meeting was to facilitate FDA regulatory communication and guidance through the IND submission process for CHM 2101.
This meeting package included details and specific questions regarding the clinical development plan and technical operations, including drug product manufacturing and the quality release plan for CHM 2101.
CHM 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.
Highly appreciative
“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 invented at the world-renowned cell therapy centre, the University of Pennsylvania.
Preclinical evidence for CHM 2101 was published in March 2022 in Nature Cancer, with the data showing strong evidence of efficacy, including complete eradication of eight different types of gastrointestinal cancers with no relapse or toxicity.
Chimeric is focused on advancing CHM 2101 towards a Phase 1A clinical trial in gastrointestinal and neuroendocrine tumours.