FDA grants Fast Track Designation to CAR T-cell therapy for kidney cancer
The FDA has granted a Fast Track Designation to the chimeric antigen receptor (CAR) T-cell therapy IVS-3001 for the treatment of patients with renal cell carcinoma (RCC), according to Invectys, Inc., the developer of the treatment.
The agency grants these designations to facilitate the development and expedite the review of novel treatment for unmet medical needs.
The autologous CAR T-cell therapy IVS-3001 is a cutting-edge immunotherapy that aims to target and kill HLA-G–bearing cells. The tumor-specific antigen HLA-G is typically only expressed during pregnancy and protects the fetus from the mother's immune system. In cancer, however, tumors can use HLA-G by creating a protective microenvironment, evading the immune system, and promoting tumor growth.
IVS-3001 aims to target this mechanism to restore the body's natural defense to fight cancer effectively and covers the main immuno-suppressive HLA-G isoform expressed by carcinoma. The product is currently in late-stage preclinical development.
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