The US Food and Drug Administration (FDA) has granted Fast Track Designation to Adicet Bio's ADI-270, a potential treatment for patients suffering with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have received treatment with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.
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An armoured allogeneic “off-the-shelf”gamma delta CAR T cell therapy, ADI-270 targets CD70-positive cancers.
ADI-270 is engineered to target CD70 by using CD27 as the natural receptor binding moiety. Additionally, it incorporates a dominant negative form of the transforming growth factor-β receptor II (dnTGFβRII), enhancing its resilience against the immunosuppressive tumour microenvironment.
The therapy is also designed to improve its exposure and persistence within the body by reducing susceptibility to host versus graft elimination. These features, alongside the demonstrated potent tumor infiltration capabilities of gamma delta 1 T cells, are expected to enhance clinical responses in RCC patients and others with CD70-positive tumours.
Adicet Bio president and CEO Chen Schor said: “We are pleased that ADI-270, our first ever gamma delta 1 CAR T cell therapy candidate to enter clinical trials for solid tumours, has been granted Fast Track Designation by the FDA.
“ccRCC is the most common type of kidney cancer, and this significant milestone underscores our commitment to advancing innovative treatments to these patients as quickly as possible.”
Adicet Bio is into discovering and developing allogeneic gamma delta T cell therapies, not only for cancer but also for autoimmune diseases.