On August 30, 2024, TaiMed Biologics announced the completion of dosing for the last participant 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. According to the clinical study plan, participants will undergo blood tests eight weeks after the last dose, followed by an additional four weeks of follow-up. 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.
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 was planned to enroll 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 first- or second-line treatment and have achieved viral suppression. During the phase 2a study, participants 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 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 of Trogarzo®, a post-attachment entry inhibitor with enhanced potency, viral coverage, and half-life. TMB-380 is a newer generation broadly neutralizing monoclonal antibody designed for enhanced viral coverage and half-life. The combination of TMB-365 and TMB-380 is designed as a safe and potent non-oral, long-acting maintenance therapy for virologically suppressed HIV-1 patients. Previous data have shown that both TMB-365 and TMB-380 are effective in reducing the virus load in patients and have demonstrated excellent antiviral activity. Their pharmacokinetic profiles support the potential for administration every two to three months. TaiMed initiated the 1b/2a clinical study for the combined use of TMB-365 and TMB-380 in 2022, with the Phase 1b study completed in September 2023. Data from the study were presented at the CROI conference in March 2024. The Phase 2a study is currently underway.
About TaiMed Biologics
TaiMed Biologics (4147.TWO), was founded in 2007 in Taiwan. It is a leading commercial-stage biotechnology company focused on developing novel therapies for HIV treatment. TaiMed successfully developed ibalizumab (Trogarzo®), the first-in-class and only monoclonal antibody approved for HIV treatment, which received U.S. FDA approval in 2018. Currently, TaiMed is focused on developing long-acting biologics and antibody-drug conjugate (ADC) for HIV therapy. Leveraging its professional expertise and experience, the company has also expanded into providing comprehensive contract development and manufacturing organization (CDMO) services to pharmaceutical clients. The company went public on the OTC Market in November 2015 and is currently part of the MSCI Small Cap Index.