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Chimeric Therapeutics gains FDA fast-track approval for CHM CDH17 gastrointestinal cancer candidate

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By Imelda Cotton - 
Chimeric Therapeutics ASX CHM CDH17 FDA designation GEP-NETs
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Chimeric Therapeutics (ASX: CHM) has received fast-track designation from the US Food and Drug Administration (FDA) for lead candidate CHM CDH17 to treat gastroenteropancreatic neuroendocrine tumours (GEP-NETs).

The FDA based its designation on the drug’s potential to improve outcomes for patients who have progressed beyond at least one prior line of therapy in the advanced or metastatic setting.

It will create a faster development pathway for CHM CDH17, giving Chimeric access to more frequent meetings with the FDA to discuss the drug’s development plan and eligibility for accelerated approval.

Rolling review

The fast-track approval includes a rolling review of Chimeric’s biologics licence application—a special feature made available to drugs that treat serious conditions and demonstrate the potential to address unmet medical needs.

Chimeric chief medical officer Jason Litten welcomed the designation.

“We are thrilled to announce that the US FDA has granted this designation and acknowledged the important unmet need that CHM CDH17 may serve for patients with GEP-NETs,” he said.

Novel therapy

CHM CDH17 is a third-generation, novel CAR-T cell therapy that targets the cancer biomarker associated with poor prognosis and metastases in common gastrointestinal tumours.

Preclinical evidence in a CDH17 CAR-T mice study published in 2022 demonstrated complete eradication of tumours in seven types of cancer.

The company developed the drug with the support of the University of Pennsylvania’s world-renowned cell therapy centre within the Abramson Family Cancer Research Institute.

Ongoing trial

Chimeric launched a Phase 1/2 trial last year to determine a recommended dose of CHM CDH17 and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer and intestinal neuroendocrine tumours.

Phase 1 will enrol up to 15 patients and lead to dose selection and expansion with indication-specific Phase 2 cohorts.

Mr Litten said the company was gaining “significant momentum” on the trial and looked forward to working with the FDA to get its advanced therapy to patients who need it most.