Posted: 8 December 2025
Chimeric Therapeutics Ltd has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for CHM CDH17 in the treatment of gastric cancer. The designation is recognised as a significant milestone for the Australian cell therapy company, qualifying CHM CDH17 for incentives such as tax credits for eligible clinical studies, exemption from user fees and the potential for seven years of market exclusivity upon approval.
“This is a great step forward in the development of CHM CDH17 to serve patients with gastric cancer, where there is a significant unmet need,” says Dr Rebecca McQualter, Chief Executive Officer of Chimeric Therapeutics.
The update comes as Chimeric continues to advance its Phase 1/2 clinical trial of CHM CDH17. Nine patients have been treated and ten enrolled to date. The two-stage study (NCT06055439) is designed to determine a recommended Phase 2 dose and assess safety and objective response rate in patients with advanced colorectal cancer, gastric cancer and gastrointestinal neuroendocrine tumours. Up to 15 participants are expected in the Phase 1 dose-escalation stage before the trial moves into indication-specific expansion cohorts.
CHM CDH17 is a third-generation, first-in-class CAR-T therapy engineered to target CDH17, a biomarker associated with poor prognosis and metastatic spread in common gastrointestinal cancers. The therapy is invented at the University of Pennsylvania in the laboratory of Professor Xianxin Hua. Preclinical findings published in Nature Cancer in March 2022 show complete tumour eradication across seven cancer models in mice.
Chimeric Therapeutics continues to progress a diversified pipeline including autologous CAR-T therapies, allogeneic NK cell platforms and four clinical-stage oncology programmes, underscoring its mission to bring innovative cell therapies to more patients.
