Clinical-Stage CD4 Antibody
Product Discovery Pre-clinical Studies Phase I Studies Phase II Studies Phase III Studies BLA / MAA Market
TMB-365   Discovery
 
 Pre-clinical Studies
 
 Phase I Studies
 
 Phase II Studies
 
 Phase III Studies
 
 BLA / MAA
 
 Market
 

TMB-365: Next-generation CD4 targeting for long-acting HIV combinations 

TMB-365 is a second-generation, long-acting CD4-targeted monoclonal antibody that builds on the scientific foundation established by ibalizumab/Trogarzo®. It is designed to combine a differentiated host-directed mechanism with broader viral-strain coverage and an extended pharmacokinetic profile suitable for long-acting development.

Building on validated CD4 science

Like ibalizumab, TMB-365 binds the CD4 receptor on host T cells and blocks HIV at the post-attachment stage of viral entry. TMB-365 was engineered as a next-generation evolution of that approach, preserving the host-cell target while addressing viral-strain sensitivity observed with first-generation ibalizumab.

 

A long-acting profile

Phase 1 clinical evaluation supported continued development of TMB-365, including its tolerability and extended pharmacokinetic profile. Those findings informed advancement into long-acting combination development.
 

Current application: TMB-365/380
TMB-365 is the host-targeting component of TMB-365/380, TaiMed's lead investigational long-acting maintenance regimen. In the combination, TMB-365's CD4-directed mechanism is paired with TMB-380, a broadly neutralizing antibody targeting HIV-1 gp120.

Explore TMB-365/380
 
Potential beyond the current combination
TMB-365's host-directed mechanism is distinct from virus-directed antiretroviral classes, creating the potential to pair it with other complementary long-acting HIV molecules. TaiMed intends to continue evaluating potential combination candidates through strategic research collaborations, in-licensing, and partnerships with other pharmaceutical and biotechnology companies.
 

  💡 A versatile combination component： TaiMed sees TMB-365 not only as part of the current TMB-365/380 regimen, but as a potentially reusable CD4-targeted component for future long-acting HIV combinations.

Partnering opportunities
TaiMed welcomes discussions with organizations developing complementary HIV mechanisms or long-acting technologies that may benefit from combination with a clinically evaluated CD4-targeted antibody.

Discuss a Collaboration
 
Milestones
  • 2019-10-01
    TMB-365 is investigational and has not been approved by the FDA or any other regulatory authority. Its safety and efficacy have not been established for any new combination outside ongoing or completed clinical research.