Lead Clinical Program
Product Discovery Pre-clinical Studies Phase I Studies Phase II Studies Phase III Studies BLA / MAA Market
TMB-365 and TMB-380 combination Discovery
 
 Pre-clinical Studie
 
 Phase I Studies
 
 Phase II Studies
 
 Phase III Studies
 
 BLA / MAA
 
 Market
 

TMB-365/380: A differentiated long-acting dual-antibody approach to HIV maintenance

TMB-365/380 is an investigational complete long-acting regimen being developed for maintenance therapy in virologically suppressed adults with HIV-1. The program is currently in Phase 2b.

A complete antibody-only regimen
TMB-365/380 combines two long-acting monoclonal antibodies with distinct and complementary mechanisms. The regimen is being developed without a small-molecule backbone, with the goal of maintaining durable viral suppression while reducing some of the treatment complexity associated with long-term HIV management.

Two antibodies. Two complementary targets.
TMB-365 | Host-cell targeting
TMB-365 is a second-generation post-attachment entry inhibitor that binds the CD4 receptor on host T cells. By acting on the host cell rather than a viral protein, TMB-365 introduces a differentiated resistance framework from virus-directed therapies.

TMB-380 | Virus targeting
TMB-380 (VRC07-523LS) is a broadly neutralizing antibody that targets the conserved CD4-binding site on HIV-1 gp120, providing a complementary virus-directed mechanism.

Together
The combination is designed to address HIV from both sides of the infection process - the host-cell receptor used for entry and a conserved site on the virus - while supporting long-acting maintenance therapy.

Why an antibody-only approach matters
Long-term HIV care increasingly intersects with management of other chronic conditions and medications. Because monoclonal antibodies are not metabolized through the same cytochrome P450 pathways as many small-molecule antiretrovirals, an antibody-only regimen may reduce some CYP-mediated drug-drug interaction considerations and small-molecule backbone complexity.

Designed with the realities of lifelong HIV care in mind
People living with HIV are living longer, and many also manage cardiovascular, metabolic, renal, psychiatric, and other chronic conditions. TaiMed believes the next generation of long-acting therapy should be evaluated not only on convenience, but also on eligibility, treatment complexity, resistance, clinical flexibility, and fit with ongoing care. TMB-365/380 is being developed against that broader standard.

Broad applicability is a development goal
Susceptibility screening can narrow the population eligible for some antibody-based HIV regimens before treatment begins. In the Phase 2a study of TMB-365/380, participants were enrolled without pre-screening for susceptibility to either antibody. Phase 2b is intended to further evaluate whether the regimen's breadth and complementary mechanism can support broader applicability in a larger population.
 

  💡 What TaiMed is evaluating： The goal is not simply fewer doses. TaiMed is evaluating whether a long-acting antibody regimen can combine durable suppression, a differentiated resistance profile, reduced treatment complexity, and broader real-world applicability.

Q2M in context: long-acting care needs options
TMB-365/380 is being evaluated on an every-two-month (Q2M) schedule. Q2M meaningfully reduces treatment touchpoints compared with daily therapy while preserving regular clinical contact. TaiMed views dosing interval as one part of a larger treatment decision: different patients may benefit from different balances of convenience, clinical follow-up, and flexibility over time.
 

Phase 2a clinical evidence

94% | Participants maintained HIV-1 RNA below 50 copies/mL through Week 24
0 | Virologic failures among participants who completed the study
Safety | No Grade 3 or 4 adverse events or serious adverse events related to study drugs were reported
CD4 | CD4+ T-cell counts remained stable through the study

 

Phase 2b development

The ongoing Phase 2b study is evaluating TMB-365/380 in 83 virologically suppressed adults with HIV-1 over 48 weeks, including comparison with continuation of daily oral combination antiretroviral therapy. Enrollment was completed in May 2026. The study is designed to further evaluate efficacy, safety, tolerability, pharmacokinetics, and the broader clinical profile of the regimen.

 

 

Milestones
  • 2019-10-01
    Interim analysis expected by year-end 2026.
Regulatory status
The U.S. Food and Drug Administration granted Fast Track Designation to TMB-365/380 in 2024.

TMB-365/380 is investigational and has not been approved by the FDA or any other regulatory authority. Its safety and efficacy have not been established.