FDA Grants Fast Track Designation to CAR T-Cell Therapy for RCC

The US Food and Drug Administration (FDA) granted a Fast Track designation to the novel drug ADI-270 for the treatment of patients with metastatic or advanced clear cell renal cell carcinoma (RCC) who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor. A Fast Track designation is intended to expedite the development and review of drugs that address an unmet medical need.

ADI-270 is an armored allogeneic “off-the-shelf” gamma delta CAR T-cell therapy candidate targeting CD70, a protein expressed on the cells of certain cancers; it uses CD27, the natural receptor of CD70. In a press release, the drug’s manufacturer, Adicet Bio, Inc., pointed out that ADI-270 is further armored by a dominant negative form of the transforming growth factor-β receptor II to provide functional resilience to the immunosuppressive tumor microenvironment.

ADI-270 is also designed to increase exposure and persistence by reducing susceptibility to host-versus-graft elimination. These characteristics, combined with the potent tumor infiltration demonstrated with gamma delta 1 T cells, aim to improve clinical responses of patients with RCC and others with CD70-positive tumors.

Adicet Bio plans to begin a phase 1 trial later this year to evaluate the safety and antitumor activity of ADI-270 in patients with RCC. Currently, CAR T-cell therapies are only FDA approved for blood cancers.