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Carina Biotech Treats First Colorectal Cancer Patient in CAR T-Cell Therapy Trial

NEW YORK – Carina Biotech said Monday that it has treated the first colorectal cancer patient in a Phase I/IIa study of its autologous cell therapy, CNA3103.

The clinical trial, which is taking place across several sites in Australia, is expected to include 45 patients with advanced, previously treated colorectal cancer who express the stem cell marker LGR5. Investigators plan to measure the autologous treatment's safety, tolerability, and preliminary efficacy as well as its pharmacokinetic and pharmacodynamic properties.

Adelaide, Australia-based Carina believes that targeting LGR5 — which is associated with poor prognosis and chemotherapy and radiation resistance — will help prevent these patients from relapsing. In preclinical studies, the firm said CNA3103 demonstrated promising results, including complete tumor regression.

"LGR5 is overexpressed in most colorectal cancers and is a marker of stemness, endowing cells with resistance to most forms of chemotherapy," Carina Chief Medical Officer Jose Iglesias said in a statement. "CNA3103 may offer a new way to target this important molecule."

To develop the cell therapy from patients' harvested cells, Carina uses a proprietary process that it believes can reduce manufacturing time and improve the quality of the CAR T cells.