Ibalizumab (TMB-355) Intravenous Push

Ibalizumab (TMB-355) is the first humanized monoclonal antibody (mAb) developed for the treatment of HIV-1 infection by blocking viral entry. Unlike other antiretroviral agents, ibalizumab binds to the second extracellular domain of the CD4 receptor, away from Major Histocompatibility Complex II molecule (MHC II) binding sites, ultimately interfering with post-attachment steps required for entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Intravenous ibalizumab was launched in the US in 2018 under the trade name Trogarzo™.

Ibalizumab Intravenous Push

TaiMed continues to work towards providing additional options for patients and healthcare professionals following the launch of ibalizumab intravenous (i.v.) infusion. A Phase 3 clinical trial investigating the i.v. push route of administration was initiated in 2019. After completion of the trial, a label extension application has been submitted to U.S. FDA to include i.v. push as an additional route of administration.

The same formulation is used for both ibalizumab i.v. infusion and i.v. push. The i.v. push route of administration will inject undiluted ibalizumab via intravenous and provide a fast and convenient dosing option.

Milestones

2019: Initiation of a phase-3 clinical trial for i.v. push in the U.S.

2021: Completion of a phase-3 clinical study for i.v. push and an application for label extension.

2022：U.S. label approval.