"We are honored to present the groundbreaking Phase 2a clinical study results at this prestigious scientific conference, which plays a critical role in advancing knowledge in the prevention, diagnosis, and treatment of HIV/AIDS and related infectious diseases.," said Dr. Jimmy Chang, CEO of TaiMed Biologics. " Long-acting monoclonal antibody therapy is particularly significant for HIV patients, as it significantly reduces the frequency of medication, alleviates the burden of daily dosing, and addresses challenges associated with poor treatment adherence. Furthermore, it offers multiple advantages compared to traditional antiretroviral therapy (ART). "
TaiMed Biologics also plans to engage with Key Opinion Leaders (KOLs) specializing in HIV/AIDS and infectious diseases during the conference to share and discuss the promising findings from its Phase 2a clinical study. These discussions aim to solidify the strategic positioning of the TMB-365/380 dual-antibody combination therapy as a potential option for HIV maintenance treatment. By highlighting the therapy’s clinical potential and market value, TaiMed seeks to pave the way for future international licensing opportunities and accelerate its global development.
About the Long-Acting TMB-365/380 Combination Phase 2a Clinical Study for HIV Maintenance Therapy
This Phase 2a clinical study aimed 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 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 was 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 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 resumed 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.
On January 7, 2025, TaiMed Biologics announced its long-acting TMB-365/380 monoclonal antibody combination HIV Therapy met all primary endpoints in Phase 2a clinical study.
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.
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.
About CROI
The Conference on Retroviruses and Opportunistic Infections (CROI) is a premier annual scientific forum that advances knowledge in the prevention, diagnosis, and treatment of HIV/AIDS and related infectious diseases. Founded in 1993, CROI brings together leading researchers, clinicians, and public health experts from around the world to present cutting-edge studies and clinical advancements. The conference covers a wide range of topics, including virology, immunology, epidemiology, and innovations in therapeutics and vaccines. By fostering collaboration and knowledge exchange, CROI plays a vital role in driving global efforts to combat HIV and other opportunistic infections, ensuring the integration of research into practice for improved public health outcomes.
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