Drug name
Last update: Sep 2026TMB-365
Developer(s)
Drug information
Not provided
TMB-365; LM-52
Not applicable (investigational; no brand name assigned)
Biotherapeutic
CD4-directed post-attachment inhibitor monoclonal antibody (second-generation ibalizumab)
TMB-365 (LM-52) is TaiMed Biologics' second-generation version of ibalizumab (Trogarzo), described by the company as having enhanced potency, broader viral coverage and extended half-life. Like ibalizumab it binds host CD4 and blocks HIV entry after attachment. It is developed only in combination with TMB-380 (VRC07-523LS, a CD4 binding site bNAb) as an antibody-only complete regimen for maintenance therapy in virologically suppressed adults, without a small-molecule backbone. The company highlights that participants were not pre-screened for susceptibility to either antibody. The phase 2b (enrolment complete) compares IV every 8 weeks with continued oral ART over 48 weeks. TaiMed has signalled an intent to seek breakthrough therapy designation and a commercial partner.
Not approved in any jurisdiction as of September 2026. Phase 2b (VISTA, NCT07215468) fully enrolled.
US FDA IND held by TaiMed Biologics for the TMB-365/TMB-380 combination.
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 and 4,800 mg IV single doses; 4,800 mg IV every 8 weeks (core regimen).
4,800 mg IV
No approved regimen. TMB-365 4,800 mg + TMB-380 4,800 mg by IV infusion every 8 weeks.
Administered without prior susceptibility screening in the phase 2a study.
Not provided
Associated compounds, formulations and regimens
TMB-365 + TMB-380
VRC07-523LS (mAb) (TMB-380)
Associated technologies
Not provided
Additional information
Developer(s)
TaiMed Biologics
Drug structure
Scale-up and manufacturing prospects
TaiMed operates its own cGMP biologics facility and CDMO business and manufactures ibalizumab, which is relevant to supply capacity. Two 4,800 mg IV doses per visit imply large protein quantities per patient-year, a significant cost-of-goods consideration for LMIC access.
Not reported for this product. Standard therapeutic mAb train may be 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.
Recombinant antibody manufactured by TaiMed Biologics (Hsinchu County, Taiwan). Process details not published.
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 ELISA used for TMB-365 and TMB-380 PK.
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