Chimeric Therapeutics reveals positive pre-IND with US FDA for CHM 2101
Chimeric Therapeutics is planning a phase 1A study of its CHM 2101 CAR-T candidate for treating gastrointestinal and neuroendocrine tumours.
Clinical stage cell therapy company Chimeric Therapeutics (ASX: CHM) has revealed a positive pre-investigational new drug (pre-IND) meeting with the US Food and Drug Administration in the lead up to a phase 1A study of its CAR-T therapy CHM 2101 in treating gastrointestinal and neuroendocrine tumours.
The pre-IND meeting aimed to facilitate regulatory communication and guidance from the FDA through the actual IND submission process for CHM 2101.
Feedback from the pre-IND meeting supported Chimeric’s planned phase 1 trial and technical operations strategy.
The FDA’s responses provided a clear path to an IND submission for CHM 2101.
“The positive feedback we received from the FDA was encouraging and aligns clearly with our development plan for CHM 2101,” Chimeric chief executive officer and managing director Jennifer Chow said.
“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,” Ms Chow added.
CHM 2101
Chimeric describes CHM 2101 has a first-in-class third generation autologous CAR-T cell therapy.
It was developed at the University of Pennsylvania, which is a world-renowned cell therapy centre.
During preclinical trials, CHM 2101 demonstrated “strong evidence of efficacy”.
It completely eradicated eight different types of gastrointestinal cancers with no relapse or toxicity.
The company is currently focussed on getting CHM 2101 into a phase 1A clinical trial in gastrointestinal and neuroendocrine tumours.
Other therapies
As well as advancing CHM 2101, Chimeric has developed CHM 1101, which is designed to target solid tumours.
CHM 1101 is also a novel CAR-T therapy and is currently being evaluated in a phase 1 trial of recurrent or progressive glioblastoma, which is the most aggressive and common form of brain cancer.
Initial data has been positive for patients treated with the first two dose levels of CHM 1101 the trial.
Chimeric is undertaking further work to use CHM 1101 in other solid tumours with metastatic melanoma the next focus.