Adicet Bio(ACET) ZACKS·2024-07-09 14:56Core Viewpoint - Adicet Bio (ACET) has received FDA Fast Track designation for its investigational candidate ADI-270, aimed at treating metastatic/advanced clear cell renal cell carcinoma (ccRCC), leading to a notable increase in its stock price [1][2]. Company Developments - ADI-270 is an allogeneic gamma delta CAR T cell therapy targeting the CD70 protein, which is prevalent in various malignancies, including ccRCC. The candidate is intended for patients previously treated with immune checkpoint inhibitors and vascular endothelial growth factor inhibitors [1]. - The FDA's Fast Track designation is designed to expedite the development and review process for drugs that show substantial improvement over existing therapies for serious conditions [2]. - Adicet plans to initiate a phase I study for ADI-270 in relapsed or refractory ccRCC patients in the second half of 2024, with clinical data expected in the first half of 2025 [3]. Financial Position - As of the first quarter of 2024, Adicet reported cash, cash equivalents, and short-term investments totaling $247.6 million, which is projected to sustain operations into the second half of 2026 [5]. Clinical Pipeline - Adicet's pipeline includes ADI-001, a first-in-class allogeneic gamma delta T cell therapy targeting CD20, currently in early-stage studies for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. A phase I study for ADI-001 in lupus nephritis is also set to begin soon [4]. - ADI-001 has also received FDA Fast Track designation for lupus nephritis, with a clinical update expected in late 2024 or early 2025 [4][5]. Market Performance - Year to date, shares of ACET have decreased by 38.1%, contrasting with a 7.9% decline in the industry [2].