Drugs / TMB-365
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04027387 | Dec 2019 → Aug 2021 | HIV infectious disease | TaiMed Biologics Inc. | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT05275998 | Jul 2022 → Nov 2024 | HIV infectious disease | TaiMed Biologics Inc. | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT07215468 | Dec 2025 → Aug 2027 expected | HIV infectious disease | TaiMed Biologics Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | TaiMed Biologics Inc. | Results TaiMed Biologics (4147) Announces First Patient in TMB-365/380 Phase 2b Trial Successfully Completes Fourth Dose; Sustained Viral Suppression Remains Consistent with Expectations, Supporting an Optimi taimedbiologics.com ↗
TaiMed stated that following the participant’s fourth dose, currently available laboratory results, including key indicators such as HIV-1 RNA (viral load) and CD4+ T Cell Count, have remained within the expected range. |
| 2025-07-25 | TaiMed Biologics Inc. | Results TaiMed Biologics (4147) Invited to Share Key Business Priorities and Strategic Plan at the 2025 Taiwan Biotech Industry Summit Forum taimedbiologics.com ↗
According to the latest clinical data, 94% of patients achieved viral suppression (HIV RNA < 50 copies/mL) within 24 weeks of treatment with no predefined virologic failure observed, demonstrating strong efficacy, safety, and tolerability. |
| 2025-07-16 | TaiMed Biologics Inc. | Results TaiMed Biologics is exhibiting at BIOAsia 2025 taimedbiologics.com ↗ |
| 2025-06-22 | TaiMed Biologics Inc. | Regulatory TaiMed Biologics has initiated Phase IIb Clinical Study Protocol Preparation of Long-Acting HIV Therapy TMB-365/380 to the U.S. FDA taimedbiologics.com ↗
TaiMed Biologics today announced that the USA FDA did not raise any concern within the mandatory 30 calendar days review period for the clinical study protocol application of combination therapy using two monoclonal antibodies (TMB-365/380). |
| 2025-03-12 | TaiMed Biologics Inc. | Results TaiMed Biologics to Present Late-Breaking Phase IIa Data at CROI 2025 on Long-Acting TMB-365/TMB-380 Regimen for HIV Maintenance Therapy. taimedbiologics.com ↗
The study results highlight the superior safety and efficacy profile of TMB-365/TMB-380—a first-of-its-kind long-acting dual bNAb regimen—for HIV maintenance therapy in participants switched from daily oral cART. |
| 2025-01-08 | TaiMed Biologics Inc. | Results TaiMed Biologics Announces its Long-Acting TMB-365/380 Monoclonal Antibody Combination HIV Therapy Meets All Primary Endpoints in Phase 2a Clinical Study taimedbiologics.com ↗
On January 7, 2025, TaiMed Biologics today announces encouraging topline results from its Phase 2a clinical study of the long-acting TMB-365 and TMB-380 investigational combination, administered intravenously every two months as a complete regimen for HIV therapy. |
| 2024-03-06 | TaiMed Biologics Inc. | Results CROI 2024 (Updated) taimedbiologics.com ↗
The results indicated that the combination therapy up to 4800 mg of each antibody was safe, with prolonged PK duration observed for both TMB-365 and TMB-380. |
| 2024-02-13 | TaiMed Biologics Inc. | Regulatory The US FDA grants Fast Track Designation to TMB-365/TMB-380 Long-Acting Combination therapy for HIV Infection taimedbiologics.com ↗
TaiMed received notification from the U.S. Food and Drug Administration (US FDA) that TMB-365/380, a long-acting monoclonal antibody for the treatment of HIV infection, has been granted the "Fast Track Designation". |
| 2023-10-05 | TaiMed Biologics Inc. | Regulatory TaiMed submitted a revised protocol to the U.S. FDA for the core group clinical trial of the blockbuster new drug 365/380 combination taimedbiologics.com ↗
To ensure the success of future clinical trials, product positioning in the market, and expedite the overall clinical trial timeline, the company submitted, on October 5, 2023, a revised protocol to the U.S. FDA for the core group clinical trial. |
| 2023-09-06 | TaiMed Biologics Inc. | Results Significant progress has been made in clinical trials of the blockbuster new drug 365/380 combination, and the results align with expectations. taimedbiologics.com ↗
TaiMed is pleased to officially announce the successful completion of the sentinel group in the phase 1b/2a clinical study evaluating Long-Acting TMB-365/TMB-380 mAb Combination Maintenance HIV Therapy at the investor's conference on September 6, 2023. |
All press releases naming this drug 28 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TMB-365 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04027387 ↗ |
| Action | Inhibit | “A monoclonal antibody acts as a HIV post-attachment inhibitor” NCT07215468 ↗ |
| Modality | Monoclonal antibody | “An IgG1 monoclonal antibody” NCT04027387 ↗ |
| Route | Intravenous | “administered via intravenous infusion (IV)” NCT04027387 ↗ |
| Target | CD4 | “targeting domain 2 of the CD4 receptor” NCT04027387 ↗ |