Adicet Bio Gains FDA Fast Track for ADI-270 in Advanced Renal Cell Carcinoma

Adicet Bio, Inc., a clinical-stage biotech firm based in Redwood City, California, and Boston, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to their leading candidate, ADI-270. This therapy is being developed for patients with metastatic or advanced clear cell renal cell carcinoma (ccRCC) who have already undergone treatment with both an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.

Chen Schor, President and CEO of Adicet Bio, expressed enthusiasm about the FDA's designation, highlighting that ADI-270 is the company's first gamma delta 1 CAR T cell therapy candidate to enter clinical trials for solid tumors. Schor emphasized that ccRCC is the most prevalent form of kidney cancer and noted that this milestone reflects Adicet Bio's dedication to developing innovative treatments for these patients as swiftly as possible.

The FDA's Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs that aim to treat serious conditions and address unmet medical needs.

ADI-270 is designed as an "off-the-shelf" allogeneic gamma delta CAR T cell therapy targeting CD70-positive cancers. CD70 has been identified as a promising target due to its high expression in both solid and hematological malignancies. ADI-270 incorporates a third-generation CAR that targets CD70 through its natural receptor, CD27, which serves as the binding moiety. Additionally, the therapy is "armored" with a dominant negative form of the transforming growth factor-β receptor II (dnTGFβRII), which helps it resist the immunosuppressive environment of the tumor. This design also aims to enhance exposure and persistence by reducing the therapy's vulnerability to host vs. graft elimination. These characteristics, combined with the potent tumor infiltration capabilities of gamma delta 1 T cells, are intended to improve clinical responses in patients with RCC and other CD70-positive tumors.

Adicet Bio, Inc. specializes in discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The company's pipeline includes "off-the-shelf" gamma delta T cells that are engineered with chimeric antigen receptors (CARs) to ensure durable activity in patients.