Chimeric Therapeutics reports encouraging Phase 1/2 data for its CHM CDH17 CAR-T therapy in advanced gastrointestinal cancers, with 82% of evaluable patients achieving stable disease and durable responses lasting over a year.
- 82% stable disease rate in evaluable patients
- Robust CAR-T cell expansion and persistence observed
- Tolerable safety profile with manageable adverse events
- Dose Level 3 enrolment ongoing with Phase 2 dose pending
- Data presented at American Society of Clinical Oncology
Strong Disease Control Signals in Advanced GI Cancers
Chimeric Therapeutics (ASX:CHM) has delivered promising early clinical data for its novel CHM CDH17 CAR-T therapy targeting advanced gastrointestinal cancers. Presented at the American Society of Clinical Oncology (ASCO), the Phase 1/2 trial showed that 9 of 11 evaluable patients (82%) achieved stable disease per RECIST criteria, with some patients maintaining disease stability for over a year; one exceeding 15 months. This marks a notable extension from the interim data reported in November 2025, which showed 75% disease control at 28 days.
Robust CAR-T Expansion and Safety Profile
The therapy demonstrated robust pharmacokinetics, with CHM CDH17 CAR-T cells expanding and persisting in the peripheral blood of all treated patients for up to 15 months. This persistence is a key factor in CAR-T efficacy and significantly de-risks the asset. The safety profile was manageable in a heavily pre-treated metastatic patient population. There was one dose-limiting toxicity involving Grade 3 cytokine release syndrome (CRS) and other related adverse events, all of which resolved. No Grade 4 or 5 treatment-related adverse events were reported, though all patients experienced Grade 4 events linked to the lymphodepletion regimen prior to infusion, consistent with expectations for cell therapies.
Dose Escalation Continues Toward Phase 2
To date, 16 subjects have been enrolled across Dose Levels 1 to 3, with 12 patients treated and 100% successful manufacturing runs. Dose Level 3 enrolment is ongoing at US cancer centres, with initial signs of efficacy emerging at this highest dose cohort. A recommended Phase 2 dose is expected to be determined following completion of Dose Level 3 enrolment, which will guide the expansion into indication-specific cohorts for colorectal, gastric, and neuroendocrine tumours.
Scientific and Clinical Collaboration Underpins Progress
CHM CDH17 is a third-generation CAR-T therapy developed in collaboration with the University of Pennsylvania, targeting CDH17, a biomarker linked to poor prognosis in gastrointestinal cancers. The trial leverages cutting-edge CAR-T technology to address a significant unmet need in relapsed or refractory GI malignancies, which collectively cause over 1.3 million deaths worldwide annually. Chimeric’s CEO Dr Rebecca McQualter highlighted the significance of presenting these data at ASCO and the company’s commitment to advancing the program.
Next Steps and Market Implications
The ongoing Phase 1/2 trial is pivotal for Chimeric’s clinical pipeline, with the CHM CDH17 program poised to advance into Phase 2 upon dose recommendation. The data reinforce the company’s strategy to develop innovative cell therapies beyond its NK cell platform, which recently showed promising results in acute myeloid leukemia. Investors will be watching closely as the company completes Dose Level 3 enrolment and prepares for the next clinical milestones that could validate CHM CDH17’s potential in a challenging oncology segment.
Bottom Line?
CHM CDH17’s durable disease stability and manageable safety in heavily pre-treated patients mark a meaningful step forward, but Phase 2 dose confirmation and broader efficacy data remain crucial next hurdles.
Questions in the middle?
- Will the Phase 2 dose recommendation confirm optimal balance of efficacy and safety?
- Can CHM CDH17 demonstrate objective tumour shrinkage or complete responses in larger cohorts?
- How will CHM’s CAR-T program compete with emerging GI cancer therapies in development?