Adicet Bio Secures FDA Fast Track Designation for ADI-270 in Advanced Metastatic Clear Cell Renal Cell Carcinoma

Adicet Bio, a clinical-stage biotechnology company focused on developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-270. This designation is for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have previously been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.

“We are pleased that ADI-270, our first gamma delta 1 CAR T cell therapy candidate to enter clinical trials for solid tumors, has been granted Fast Track Designation by the FDA,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “ccRCC is the most common type of kidney cancer, and this significant milestone underscores our commitment to advancing innovative treatments for these patients as quickly as possible.”

Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.

ADI-270 is an armored allogeneic “off-the-shelf” gamma delta CAR T cell therapy candidate targeting CD70-positive cancers. CD70 is a compelling target due to its high expression in both solid and hematological malignancies. ADI-270 is engineered with a third-generation CAR designed to target CD70 using its natural receptor, CD27, as the binding moiety. It is further armored with a dominant-negative form of the transforming growth factor-β receptor II (dnTGFβRII) to provide functional resilience to the immunosuppressive tumor microenvironment. ADI-270 is also designed to increase exposure and persistence by reducing susceptibility to host vs. graft elimination. These properties, combined with the potent tumor infiltration demonstrated by gamma delta 1 T cells, aim to improve clinical responses in RCC patients and others with CD70+ tumors.

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