Chimeric Therapeutics Ltd (ASX:CHM, OTC:CHMMF) has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its CHM CDH17 cell therapy candidate in the treatment of gastric cancer. The designation provides development incentives including tax credits for eligible clinical trials, exemption from FDA user fees and, if approved, up to seven years of market exclusivity in the United States.
The company is currently progressing a Phase 1/2 clinical trial (NCT06055439) evaluating CHM CDH17 in advanced colorectal cancer, gastric cancer and gastrointestinal neuroendocrine tumours. The study has treated nine patients to date, with 10 patients enrolled.
The two-stage trial is designed to establish a recommended Phase 2 dose and assess safety and objective response rate. The Phase 1 component is expected to enrol as many as 15 patients before dose selection and expansion into indication-specific Phase 2 cohorts.
“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,” CEO of Chimeric Therapeutics Dr Rebecca McQualter said.
Pipeline and technology overview
CHM CDH17 is a first-in-class, third-generation CAR-T therapy targeting CDH17, a biomarker linked to poor prognosis and metastasis across common gastrointestinal cancers. The therapy was invented at the University of Pennsylvania in the laboratory of Professor Xianxin Hua, with preclinical data published in Nature Cancer in March 2022 showing complete tumour eradication in seven cancer models in mice.
Chimeric’s broader pipeline spans autologous CAR-T and allogeneic NK cell therapies across four clinical-stage programs. Its CORE-NK platform, which has demonstrated activity in blood cancers and solid tumours, has advanced into two Phase 1B combination trials. Next-generation NK and CAR-NK candidates are also under development.
The company’s CLTX CAR-T program, targeting solid tumours, is being investigated in a Phase 1B trial in recurrent or progressive glioblastoma, following positive preliminary data from an investigator-initiated Phase 1A study reported in October 2023.