All subjects who completed the trial showed no virologic failure; and there was no grade 3 or grade 4 adverse events, nor any serious adverse events related to TMB-365 and TMB-380. The pharmacokinetic profile was consistent with results from previous clinical trials.
Dr. Jimmy Chang, CEO of TaiMed Biologics, stated, “The result of this clinical trial is impressive and represent a significant milestone for TaiMed. Not only have we confirmed that using monoclonal antibodies with complementary mechanisms of action as a novel maintenance therapy for HIV is both effective and safe, but the efficacy and safety data from this trial also surpass the results of other known long-acting combination therapies. These exciting results will significantly enhance the value of the TMB-365 and TMB-380 combination and facilitate future international licensing opportunities. TMB-365/380 long-acting combination could potentially be the First-in-Class and Best-in-Class HIV therapy. The long-acting regimen is a crucial treatment option for people living with HIV, and the target population is for this frontline therapy offers a market potential of US $10 billion.”
Full results from the clinical study will be submitted for presentation at an upcoming medical conference. TaiMed will release further progress and results in due course.
The company is on track to finalize the clinical study report in the coming months, and it plans to submit its Phase 2b clinical trial proposal to the U.S. Food and Drug Administration (FDA). TaiMed is also actively pursuing licensing and partnership opportunities with leading pharmaceutical companies. Additionally, the company aims to initiate development of a subcutaneous injection formulation of TMB-365/TMB-380, providing a self-administration option to further enhance convenience and privacy for individuals living with HIV.
About the Long-Acting TMB-365/380 Combination Phase 2a Clinical Study for HIV Maintenance Therapy
This clinical study aims to evaluate the safety, efficacy, and pharmacokinetics profile of the long-acting TMB-365/TMB-380 combination as a complete regimen for HIV maintenance therapy. The study targets to enroll 20 participants, using a dosing regimen of one injection every eight weeks, to collect data on the efficacy, safety, and pharmacokinetics of the dual-antibody combination. A total of 18 participants completed the trial. This information will be used to assess and design future clinical studies. The target population for this study is HIV patients who have undergone treatment and have achieved viral suppression. During phase 2a study, participants are switched to the long-acting TMB-365/TMB-380 combination and discontinued oral antiretroviral therapy. Each participant received up to three doses, once every eight weeks, with blood tests conducted to monitor viral load and plasma drug concentration. After completion of the study, participants will resume daily oral antiretroviral therapy, followed by four weeks of post-treatment monitoring and data analysis. This clinical trial was not a double-blind placebo-controlled study; therefore, no statistical p-values were reported for the results.
About the TMB-365/TMB-380 Dual-Antibody Combination
TMB-365/380 is a novel, long-acting monoclonal antibody combination being developed as a complete regimen for front-line HIV maintenance therapy. This new therapy aims to be the First-in-Class, Best-in-Class, and captures a significant portion of the US $10 billion first line long-acting maintenance therapy market.
TMB-365 is a second-generation post-attachment entry inhibitor derived from Trogarzo® with enhanced potency, viral coverage, and longer half-life. TMB-380 is a new generation broadly neutralizing monoclonal antibody, also designed for improved viral coverage and half-life. Together, these antibodies construct a robust non-oral regimen aimed as maintenance therapy for virologically suppressed HIV-1 patients.
Clinical data have demonstrated the efficacy of both TMB-365 and TMB-380 in reducing the viral load in patients and have demonstrated excellent antiviral activity. TaiMed initiated a 1b/2a clinical study in 2022, with Phase 1b completed in September 2023. Notably, the Phase 1b study results were presented at CROI conference in March 2024, highlighting their potential impact on treatment strategies. The last patient last visit of the current phase 2a study was completed in November 2024. The Phase 2a results further elucidated the benefits of this combination.
As TMB-365/TMB-380 progress through clinical trials, it has the potential to reshape the landscape of HIV maintenance therapy, offering a long-awaited solution for patients seeking safe and effective, long-acting treatment options.
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