CHM CDH17 Shows Up to 37% Tumour Reduction with Safe Dose Level 2
Chimeric Therapeutics reports encouraging early clinical trial outcomes for its CHM CDH17 CAR-T therapy, showing disease control and tumour shrinkage at higher dose levels with a strong safety profile.
- Dose Level 2 deemed safe by Safety Monitoring Committee
- Tumour shrinkage between 12-37% observed in colorectal and neuroendocrine cancer patients
- One patient maintains stable disease over 10 months post single dose at Dose Level 1
- No off-target effects or gastrointestinal toxicity reported
- Trial progressing towards dose selection and Phase 2 expansion
Early Signs of Efficacy in CHM CDH17 Trial
Chimeric Therapeutics, an Australian biotechnology company focused on cell therapies, has announced promising early results from its Phase 1/2 clinical trial of CHM CDH17, a novel CAR-T therapy targeting gastrointestinal cancers. The Safety Monitoring Committee has approved Dose Level 2 for further exploration after observing encouraging disease control and tumour shrinkage in patients.
Four patients have been treated at this higher dose, with two undergoing tumour assessments showing mixed responses. Notably, tumour burden decreased by 12% in a colorectal cancer patient and between 6-16% in a neuroendocrine tumour patient, with one tumour shrinking by as much as 37%. These outcomes have resulted in a RECIST classification of stable disease, indicating the cancer has not progressed and some tumours have reduced in size.
Durability and Safety Stand Out
Beyond the immediate tumour responses, one patient treated at the lower Dose Level 1 continues to exhibit stable disease more than 10 months after a single dose, with tumour shrinkage deepening over time. This durability is particularly encouraging in the context of advanced gastrointestinal cancers, which are often difficult to treat effectively.
Importantly, the trial has reported no evidence of off-target effects or gastrointestinal toxicity, common concerns with CAR-T therapies. This safety profile supports the ongoing dose escalation and expansion phases of the study.
A Step Forward for CAR-T in Solid Tumours
CHM CDH17 represents a third-generation CAR-T therapy developed in collaboration with the University of Pennsylvania, targeting CDH17, a biomarker linked to poor prognosis in gastrointestinal tumours. The trial aims to establish a recommended Phase 2 dose and evaluate objective response rates across colorectal, gastric, and neuroendocrine cancers.
Chimeric’s CEO, Dr Rebecca McQualter, expressed optimism about the results, highlighting the potential for CHM CDH17 to offer meaningful benefits to patients. The company’s broader pipeline includes other innovative cell therapies, positioning it as a leader in the evolving field of oncology cell therapy.
While these early findings are promising, the small patient numbers and mixed tumour responses underscore the need for continued monitoring and data from additional participants to confirm efficacy and safety.
Bottom Line?
As Chimeric advances CHM CDH17 through clinical development, upcoming patient data will be critical to validating its potential as a new treatment for tough-to-treat gastrointestinal cancers.
Questions in the middle?
- Will the tumour shrinkage observed translate into longer-term survival benefits?
- How will additional patients at Dose Level 2 respond, and will a clear dose recommendation emerge?
- What are the prospects for regulatory approval and commercialisation timelines based on these early results?
