FDA Fast Tracks Adicet Bio's ADI-001 for Lupus Nephritis

Adicet Bio, Inc., a clinical-stage biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the possible treatment of relapsed/refractory class III or class IV lupus nephritis.

According to Chen Schor, President and Chief Executive Officer of Adicet Bio, the FDA's decision highlights the critical demand for new therapeutic options for this chronic illness. Schor mentioned that the company intends to begin its Phase 1 clinical study on lupus nephritis later this month. He also pointed out that clinical data for ADI-001 in non-Hodgkin’s lymphoma has shown CD19+ B-cell depletion, akin to data from autologous alpha-beta CAR T treatments in academic clinical studies for various autoimmune diseases. Schor believes this positions Adicet well to broaden its autoimmune program to treat conditions beyond lupus nephritis. The company aims to update investors on its autoimmune program soon.

Fast Track Designation is a process established to speed up the development and review of drugs aimed at treating serious conditions and addressing unmet medical needs.

About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical-stage biotechnology firm focused on the discovery and development of allogeneic gamma delta T cell therapies for both autoimmune diseases and cancer. The company is advancing a pipeline of "off-the-shelf" gamma delta T cells, which are engineered with chimeric antigen receptors (CARs) to provide durable activity in patients.

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