On November 22, 2024, TaiMed Biologics announced the completion of the last participant last visit (LPLV) in the Phase 2a clinical study of the long-acting TMB-365 and TMB-380 combination, administered every two months as a complete regimen for HIV therapy. Topline data from the Phase 2a clinical trial are expected by the end of 2024 or early 2025, and the Company plans to present the results at an upcoming international conference. If the results meet expectations, the Phase 2b clinical trial is projected to begin in 2025, with continued discussions for licensing and collaboration with major pharmaceutical companies.
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 enrolled 20 participants, using a dosing regimen of one injection every eight weeks, to collect data on the effectiveness, safety, and pharmacokinetics of the dual-antibody combination. 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 the phase 2a study, participants are switched to the long-acting TMB-365/TMB-380 combination and discontinued other antiretroviral medications. Each participant received up to three doses, one dose every eight weeks, with blood tests conducted to monitor viral load and plasma drug concentration. After completion of the study, participants will resume oral daily antiretroviral therapy, followed by four weeks of post-study monitoring and data analysis.
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 capture 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®, boasts enhanced potency, viral coverage, and longer half-life. Complementing it, TMB-380 is a newer generation broadly neutralizing monoclonal antibody, also designed for improved viral coverage and half-life. Together, these antibodies provide a robust non-oral regimen aimed as maintenance therapy for virologically suppressed HIV-1 patients.
Clinical data have demonstrated the effectiveness 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 the Phase 1b completed in September 2023.  Notably, findings from this study were presented at CROI conference in March 2024, highlighting their potential impact on treatment strategies.  The ongoing Phase 2a is expected to further elucidate 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 effective, long-lasting treatment options.