Drug name
Last update: Sep 2026TMB-365 + TMB-380
Developer(s)
Drug information
Not provided
TMB-365/TMB-380; TMB-365/380; LM-52 + VRC07-523LS
Not applicable (investigational; no brand name assigned)
Biotherapeutic
Two monoclonal antibodies: CD4-directed post-attachment inhibitor (TMB-365) + CD4 binding site bNAb (TMB-380)
TMB-365/TMB-380 is TaiMed Biologics' antibody-only, investigational long-acting complete regimen for maintenance therapy in virologically suppressed adults with HIV-1, given as two IV infusions every 8 weeks without a small-molecule backbone. It combines two complementary mechanisms: TMB-365 (LM-52), a second-generation ibalizumab that binds host CD4 and blocks entry after attachment, and TMB-380 (VRC07-523LS), a bNAb against the CD4 binding site on the viral envelope. TaiMed's press release reported that 94% maintained HIV-1 RNA below 50 copies/mL through treatment in the open-label phase 1b/2a study.
Not approved. Phase 2b (VISTA, NCT07215468), fully enrolled June 2026. US FDA IND (TaiMed); FDA Fast Track designation reported by TaiMed.
Unknown
Therapeutic area(s)
- HIV
- Treatment
Administration route
Intravenous
Associated long-acting platforms
Monoclonal antibodies and antibody drug conjugates
Use of drug
- Administered by a nurse
- Administered by a specialty health worker
- Every 2 months
Dosage
Investigational: 2,400, 3,200 or 4,800 mg of each antibody IV. Infusions are given separately and sequentially.
4,800 mg of each antibody IV per visit
No approved regimen. TMB-365 4,800 mg IV + TMB-380 4,800 mg IV every 8 weeks, as a switch from suppressive oral ART.
No susceptibility screening in phase 2a. An every-12-week schedule was in the original IND scope.
Not provided
Additional information
Developer(s)
TaiMed Biologics
Drug structure
Scale-up and manufacturing prospects
Not reported. About 9.6 g of antibody per visit (4,800 mg of each), roughly 62 g per patient-year, is far above small-molecule long-acting regimens and is the central affordability question for LMIC use. TaiMed manufactures biologics in-house.
Not reported for this product. Standard therapeutic mAb train assumed: production bioreactors, disc-stack centrifugation and depth/membrane filtration for harvest clarification, Protein A and polishing chromatography, viral inactivation and filtration, ultrafiltration/diafiltration, sterile fill-finish.
Two recombinant antibodies; TaiMed cGMP facility, Hsinchu County, Taiwan (TMB-365). TMB-380 supply source not disclosed.
Not reported for this product. Standard mAb characterisation applies: ion-exchange chromatography and capillary isoelectric focusing (charge variants), size-exclusion chromatography (aggregates), DSC (thermal stability), subvisible particle counting, ELISA for serum concentrations, TZM.bl neutralisation assays for susceptibility. Validated ELISAs for each antibody.
Excipients & delivery device(s)
Not provided
Not provided
Not provided
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided
There are either no relevant patents or these were not yet submitted to LAPaL