On March 20, 2023 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical stage cell therapy company and an Australian leader in cell therapy, reported that it has successfully completed a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) and has received positive feedback on the development plan for CHM 2101 (Press release, Chimeric Therapeutics, MAR 20, 2023, View Source [SID1234629156]).

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This is a significant milestone towards an Investigational New Drug (IND) Application and Phase 1 clinical trial for CHM 2101. The objective of the meeting was to facilitate FDA regulatory communication and guidance through the IND submission process for CHM 2101. The pre-IND meeting package included details and specific questions regarding the clinical development plan and technical operations, including drug product manufacturing and quality release plan for CHM 2101.

The company 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 Jennifer Chow, Chimeric’s Chief Executive Officer and Managing Director. "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, 3rd generation autologous CAR T cell therapy invented at the worldrenowned cell therapy centre, the University of Pennsylvania. Preclinical evidence for CHM For personal use only 2101 was published in March 2022 in Nature Cancer, with the data demonstrating strong evidence of efficacy with 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.