August 13, 2020 -- The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Akeso for Ak104, a bispecific antibody, as a monotherapy for the treatment of patients with recurrent or metastatic squamous cervical cancer.
Ak104 is a humanized immunoglobulin G (IgG1) tetrameric bispecific antibody drug candidate designed to preferentially bind to tumor infiltrating lymphocytes. It targets two immune checkpoint molecules -- programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) -- simultaneously. The antibody was developed using Akeso's proprietary Tetrabody technology platform. The therapy is currently undergoing phase Ib/II and phase II clinical trials in China and Australia for multiple indications.