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FDA Clears Chimeric to Begin CAR T Clinical Trial in Gastrointestinal Cancers

NEW YORK – Australian biopharma firm Chimeric Therapeutics on Tuesday said the US Food and Drug Administration has cleared it to begin a clinical trial of its CAR T-cell therapy CHM 2101 for gastrointestinal cancers.

CHM 2101 targets CDH17, a cell surface protein that plays an important role in establishing cell-cell interactions. When upregulated, CDH17 is associated with worse overall survival compared to patients without expression of the gene.

In preclinical studies conducted by researchers at the University of Pennsylvania, CHM 2101 eradicated established tumors in seven cancer models with no toxicity to normal tissues.

In a Phase I/II trial, Chimeric researchers will assess safety of CHM 2101 and objective response rate in patients with advanced gastrointestinal cancers that are relapsed or refractory to at least one standard treatment regimen in the advanced setting. Patients with gastric adenocarcinoma, colon, rectal cancer and certain neuroendocrine tumors will be enrolled in the trial. For gastric adenocarcinoma only, patients must test positive for CD17 expression. As secondary outcome measures, the researchers will monitor disease control rate, time to response, duration of response, progression-free survival, and overall survival.