Chimeric Therapeutics Receives FDA Orphan Drug Designation for CHM CDH17 CAR-T Therapy in Gastric Cancer
核心洞察
Chimeric Therapeutics (搜索) has secured FDA Orphan Drug Designation for CHM CDH17 (搜索), a first-in-class CAR-T therapy targeting gastric cancer (搜索), providing development incentives including tax credits and up to seven years of market exclusivity.
The company is currently conducting a Phase 1/2 clinical trial evaluating CHM CDH17 (搜索) in advanced colorectal cancer (搜索), gastric cancer (搜索), and gastrointestinal neuroendocrine tumors, with nine patients treated and 10 enrolled to date.
CHM CDH17 (搜索) targets CDH17 (搜索), a biomarker linked to poor prognosis and metastasis in gastrointestinal cancers, with preclinical data showing complete tumor eradication in seven cancer models in mice.
Chimeric Therapeutics (搜索) Ltd has received Orphan Drug Designation from the US Food and Drug Administration for its CHM CDH17 (搜索) cell therapy candidate in the treatment of gastric cancer (搜索). 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 (搜索) in advanced colorectal cancer (搜索), gastric cancer (搜索) and gastrointestinal neuroendocrine tumours (搜索). The study has treated nine patients to date, with 10 patients enrolled.
Clinical Trial Design and Progress
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 (搜索) to serve patients with gastric cancer (搜索), where there is a significant unmet need," said Dr Rebecca McQualter, CEO of Chimeric Therapeutics (搜索).
Novel CAR-T Technology Platform
CHM CDH17 (搜索) is a first-in-class, third-generation CAR-T therapy targeting CDH17 (搜索), 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.
Strategic Regulatory Approach
The company plans to intensify its global regulatory strategy, prioritising submissions and engagement in the United States, European Union and China, where orphan pathways can significantly streamline development and commercialisation. These markets collectively represent the greatest opportunity to bring its treatment to patients while establishing the company as a competitive player in the global rare-disease landscape.
Broader Pipeline Development
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 (搜索), following positive preliminary data from an investigator-initiated Phase 1A study reported in October 2023.