Drugs / VRC07-523LS
Trials 26
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-07-16 | TaiMed Biologics Inc. | Results TaiMed Biologics is exhibiting at BIOAsia 2025 taimedbiologics.com ↗
Recently selected as a Late-Breaking Abstract at CROI 2025, the study showed high safety and viral suppression without the need for susceptibility screening—offering a more convenient and effective option for HIV maintenance therapy. |
| 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 ↗
Taipei, Taiwan –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. |
| 2025-03-12 | Gilead Sciences | Results Gilead Presents New HIV Treatment and Cure Research Data at CROI 2025, Including an Investigational Long-Acting, Twice-Yearly Therapy Option gilead.com ↗
Results presented at CROI showed the treatment combination was generally well-tolerated with no treatment-related serious adverse events (TEAEs) reported. |
| 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 ↗
The study results met all the primary endpoints designed to evaluate the safety, efficacy, and pharmacokinetics profile. |
| 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. |
| 2023-02-21 | Gilead Sciences | Results Gilead Presents New Data From HIV Cure Research Program and Collaborations Exploring Novel Investigational Combinations and Strategies gilead.com ↗
combination immunotherapy consisting of a vaccine, an immune modulator, and bNAbs (10-1074 and VRC07-523LS) may provide virologic control. |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VRC07-523LS | “the Broadly Neutralizing Antibodies VRC07-523LS and PGT121 Plus or Minus haNK Cells for Reduction of HIV Reservoirs” NCT04144335 ↗27“single dose of two bNAbs (VRC07-523LS and 10-1074, which target CD4 binding site and V3 loop, respectively)” NCT04357821 ↗ “Study products: CAP256V2LS and VRC07-523LS administered as separate injections” NCT07810062 ↗ |
| Known as | VRC-HIVMAB075-00-AB | “A Phase I Safety and Pharmacokinetics Study to Evaluate a Human Monoclonal Antibody (MAB) VRC-HIVMAB095-00-AB (10E8VLS) Administered Alone or Concurrently with MAB...” NCT03565315 ↗2“VRC07-523LS (VRC-HIVMAB075-00-AB) is a recombinant human immunoglobulin G1 (IgG1) broadly neutralizing monoclonal antibody (bNAb) directed against the HIV-1 CD4 binding site” NCT06484335 ↗ “VRC-HIVMAB075-00-AB (VRC07-523LS) is a human monoclonal antibody (mAb) that targets the HIV-1 CD4 binding site.” NCT04983030 ↗ |
| Modality | Monoclonal antibody | “VRC01, VRC01LS, and VRC07-523LS are anti-HIV neutralizing monoclonal antibodies” NCT02256631 ↗ |
| Route | Intravenous | “PGDM1400 + PGT121 + VRC07-523LS (20mg/kg + 20mg/kg + 20 mg/kg IV)” NCT03205917 ↗ |