Chimeric Therapeutics (ASX:CHM) has reported encouraging new data from its ongoing Phase 1/2 clinical trial of CHM CDH17, a next-generation CAR-T therapy targeting gastrointestinal cancers.
The Sydney-based company said 75 per cent of evaluable participants in the trial achieved disease control at 28 days, with continued tumour shrinkage observed across the treated population. Four patients treated at Dose Level 2 all achieved stable disease under the international RECIST 1.1 assessment criteria, which measure changes in tumour size through imaging.
In total, six of eight evaluable patients showed disease control at the first 28-day assessment, and five of those continue to experience ongoing stable disease, including one patient who remains progression-free almost a year after receiving a single dose—without any further anticancer therapy.
“It is encouraging to see this progress for CHM CDH17 and the impact on patients is remarkable,” said Dr Rebecca McQualter, Chief Executive Officer of Chimeric Therapeutics. “We look forward to reporting further updates, including greater detail around the duration of these responses.”
CHM CDH17 is a third-generation, novel CAR-T cell therapy that targets CDH17, a cancer biomarker linked with metastasis and poor prognosis in common gastrointestinal tumours. The therapy is designed to treat advanced colorectal, gastric and gastrointestinal neuroendocrine cancers. These are diseases with limited treatment options and high unmet need.
The ongoing Phase 1/2 study (NCT06055439) is being conducted in two stages. The first aims to determine the recommended Phase 2 dose and evaluate safety, while the second will measure the therapy’s objective response rate in defined tumour types. Up to 15 patients are expected to enrol in the initial phase, with indication-specific expansion cohorts to follow.
For Chimeric, the early data signal progress toward validating its platform approach to precision cell therapy. As Dr McQualter noted, “The results we’re seeing at this stage underscore the potential of CDH17-targeted CAR-T therapy to change outcomes for patients with some of the most challenging solid tumours.”