2017-04-28
TaiMed Submits Biologics License Application for HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab
On April 28, 2017 TaiMed Biologics, Inc. has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ibalizumab for the treatment of multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing. As ibalizumab has received the Breakthrough Therapy and Orphan Drug Designations, TaiMed has requested Priority Review for the application. The ibalizumab BLA is based on data from the phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen (OBR) in treatment-experienced patients infected with MDR HIV-1. Full results from the trial were recently presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2017. About ibalizumab Ibalizumab is an investigational humanized monoclonal antibody being developed for the treatment of MDR HIV-1 infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents. Ibalizumab has received “Breakthrough Therapy” designation from the FDA, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted “Orphan Drug” designation.