By - Ankit Sethi
- Chimeric Therapeutics' CHM 2101 has received positive feedback and guidance for proposed Phase 1 clinical trial
- The advice of the US FDA supports the planned clinical trial of the therapy in gastrointestinal and neuroendocrine tumors
- The meeting included specific questions on Chimeric's clinical development plan and technical operations
Australia's listed cellular therapy company Chimeric Therapeutics (ASX: CHM) has announced to have received positive and encouraging feedback from the US Food and Drug Administration (FDA) after a pre-Investigational New Drug (pre-IND) meeting for its CAR T cell therapy CHM 2101. Chimeric has stated that this is an important milestone towards an Investigational New Drug Application and clinical trial (Phase 1) of CHM 2101.
The leader in cell therapy in the country has said that the pre-IND meeting has been successfully concluded with the FDA, with the latter giving positive feedback on CHM 2101 development plans. The meeting’s goal was to facilitate regulatory communication and guidance through the Investigational New Drug Application submission process.
The meeting focused on questions on clinical development and technical operations, which include the drug product manufacturing and quality release for the therapy, Chimeric has stated.
The US FDA has given encouraging written responses to Chimeric, which according to the latter “validate” its efforts and successes with respect to preparing CHM 2101 for clinic.
Source: CHM ASX announcement dated 21 March 2023
Chimeric states that it is a first in class, third generation autologous CAR T therapy (cellular). The therapy was invented by the University of Pennsylvania, a facility that is a globally renowned cellular therapy centre. CHM 2101’s preclinical evidence has suggested strong evidence of efficacy, CHM has stated. The data demonstrated full eradication of eight types of gastrointestinal cancers, without any incident of relapse or toxicity. The evidence was published in Nature Cancer journal in March last year.
The company is looking toward advancing the cell therapy toward Phase 1A clinical trial for treatment of gastrointestinal and neuroendocrine tumours.
Notably, Chimeric’s CHM 2101 is one of its many cell therapies that include CHM 1101 (CLTX CAR T), which is currently in clinical trial (Phase 1) in recurrent / progressive glioblastoma, and CHM 0201 (CORE-NK platform), which has advanced into Phase 1B clinical trial in blood cancers and solid tumours. Chimeric states that its team of cell therapy experts is targeting discovery, development, and commercialisation of innovative and promising therapies.
CHM shares were trading at AU$0.061 midday on 23 March 2023, up 1.6% from the last close.