Dose Escalation Success Raises Stakes for Chimeric’s Gastrointestinal Cancer Therapy

Advancing the Dose with Confidence

Chimeric Therapeutics (ASX:CHM) has announced a significant milestone in its clinical development of CHM CDH17, a novel CAR-T cell therapy targeting gastrointestinal cancers. The company has safely escalated its trial to Dose Level 2, administering 150 million CAR-T cells, after completing Dose Level 1 at 50 million cells without any safety concerns or off-target effects. This progression marks a critical step in the Phase 1/2 trial designed to establish the optimal dosing and evaluate the therapy’s safety and efficacy.

Safety and Early Signs of Efficacy

The initial cohort of four patients, including those with colorectal cancer and intestinal neuroendocrine tumors, tolerated the therapy well. Notably, no dose-limiting toxicities were reported, and only one patient experienced a mild Grade 1 cytokine release syndrome, a common immune response indicating CAR-T cell activity. Encouragingly, two patients demonstrated stable disease for several months, suggesting potential clinical benefit in these advanced cancer cases.

Manufacturing and Trial Design

Chimeric has completed seven successful manufacturing runs of the CHM CDH17 CAR-T cells, underscoring the company’s capability to produce this complex therapy reliably. The ongoing Phase 1/2 trial, which aims to enroll up to 15 patients in its dose escalation and expansion phases, is focused on patients with relapsed or refractory gastrointestinal cancers, including colorectal, gastric, and neuroendocrine tumors. The trial’s design allows for careful dose escalation to identify a recommended Phase 2 dose while monitoring safety and early efficacy signals.

Scientific Foundations and Future Potential

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. Preclinical studies published in Nature Cancer demonstrated the therapy’s ability to eradicate tumors in multiple cancer types in animal models. This clinical advancement builds on that strong scientific foundation, positioning CHM CDH17 as a promising candidate in the evolving landscape of cell therapies for solid tumors.

Looking Ahead

With Dose Level 2 underway, Chimeric Therapeutics is poised to gather more comprehensive data on safety and therapeutic activity. The company’s CEO, Dr. Rebecca McQualter, highlighted this milestone as a key momentum builder for the technology’s promise. As the trial progresses, investors and the oncology community will be watching closely for further efficacy signals and the eventual determination of the optimal dose for Phase 2 expansion cohorts.