Chimeric Therapeutics has announced plans to commence a Phase IA/B clinical trial of CHM 2101 to treat gastrointestinal cancers.
The move comes after the US Food and Drug Administration (FDA) granted clearance for the company’s investigational new drug (IND) application for the first in class CDH17 chimeric antigen receptor (CAR) T cell therapy.
The open label, multicentre trial will assess CHM 2101 in individuals with neuroendocrine tumours, advanced colorectal cancer, and gastric cancer.
Chimeric anticipates commencing subject enrolment in the Phase I portion of the trial next year.
CHM 2101 acts on a cancer target named autologous cadherin 17 (CDH17).
CDH17 is linked a poor prognosis and metastasis in gastrointestinal cancers.
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Preclinical research showed that CHM 2101 was demonstrated to destroy established tumours in seven cancer models, without causing any toxicity to normal tissues.
Chimeric focuses on developing cell therapies for cancer and has a portfolio comprising autologous CAR T cell therapies and allogeneic NK cell therapies.
The company is evaluating its assets for various oncology indications, with three clinical programmes underway. It also anticipates launching further clinical programmes this year.
In addition to CHM 2101, the company’s assets include CHM 1101, a CAR T therapy being studied in a Phase IB clinical trial for recurrent/progressive glioblastoma.
Another asset CHM 0201 is a NK cell therapy, which completed a Phase IA trial for treating blood cancers and solid tumours.
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