TMB-365 + TMB-380

Drug information

Delivery device(s)

No delivery device

Scale-up 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.

Tentative equipment list for manufacturing

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.

Manufacturing

Two recombinant antibodies; TaiMed cGMP facility, Hsinchu County, Taiwan (TMB-365). TMB-380 supply source not disclosed.

Specific analytical instrument required for characterization of formulation

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.

VISTA

Identifier

NCT07215468

Link

https://clinicaltrials.gov/study/NCT07215468

Phase

Phase II

Status

Active, not recruiting

Sponsor

TaiMed Biologics Inc.

More details

TMB-365 is a monoclonal antibody that binds to the CD4 receptor. TMB-380, aka VRC07-523LS is a monoclonal antibody that binds to HIV. Both interfere with HIV entry. This study is designed to test the combination of the antibodies as maintenance therapy in HIV infected suppressed individuals discontinuing oral cART for 48 weeks. Researchers will compare TMB-365/TMB-380 given IV every 8 weeks to continuation of daily oral cART to see if TMB-365/TMB-380 can also maintain viral suppression. Participants will: 1. Receive TMB-365/TMB-380 infusion or take oral cART as scheduled for 48 weeks 2. Visit the clinic as schedule for checkups and tests

Purpose

HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-12-16

Anticipated Date of Last Follow-up
2026-08-05

Estimated Primary Completion Date
2027-05-01

Estimated Completion Date
2027-05-01

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: 1. At least 18 years of age on the day of Screening. 2. Asymptomatic HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by Geenius™ or a second antibody test by a method other than the initial rapid HIV and/or E/CIA test, or by HIV-1 antigen, plasma HIV-1 RNA viral load at or prior to screening. 3. On continuous suppressive cART for at least 6 months prior to Screening with one documented HIV-1 RNA level \<50 copies/mL within 6 months of Screening. Continuous cART is defined as no interruptions greater than 3 consecutive days. cART is defined as a DHHS recommended regimen. Study participants should be on a stable oral regimen for at least 3 months prio

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

88

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

There are no publication

Additional documents

• A 24- Week Phase II Maintenance Study of TMB365/380 Q8W in People with suppressed HIV-1 — Jacob P. Lalezari, 2025-03-19

• Study protocol: A Phase 1b/2a Dose Escalation Study of the Safety, PK, and Efficacy of the Combination of TMB-365 and TMB-380 in HIV-1 positive Individuals Suppressed wCombination Antiretroviral Thera — TaiMed, 2024-06-23

Useful links

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