TaiMed Biologics announced on the 22nd the official launch of its Phase IIb clinical trial for the combination therapy TMB-365/380. The trial’s primary efficacy endpoint will evaluate the proportion of participants with HIV-1 RNA below 50 copies/mL at week 48, based on the Snapshot analysis method. In addition to expanding the number of participants, the trial will also extend its geographic scope beyond the United States to include Taiwan, with a total enrollment target of 75 subjects.
On May 21, 2025, TaiMed submitted a clinical trial protocol to the U.S. FDA for the Phase IIb study of the dual monoclonal antibody therapy TMB-365/380. The FDA raised no objections during the mandatory 30-day review period, clearing the way for trial initiation under the submitted protocol.
This Phase IIb trial will assess the efficacy and safety of administering the TMB-365 and TMB-380 antibody combination via intravenous infusion every eight weeks as a long-acting maintenance therapy for HIV suppression. The study will compare the investigational regimen to the current standard daily oral combination antiretroviral therapy (cART). Approximately 15 clinical sites across North America and Taiwan will participate in this one- to two-year study, which builds on the previous Phase IIa trial that enrolled 21 participants in North America and followed them for 24 weeks.
The primary endpoint is the proportion of participants with HIV-1 RNA below 50 copies/mL at week 48 based on Snapshot analysis. Secondary endpoints include virologic failure rates, safety, and tolerability. Participants must have already achieved stable viral suppression. The trial is designed with two arms: Group A (50 participants) will receive TMB-365/380 every eight weeks, while Group B (25 participants) will continue daily oral cART.
James Chang, CEO of TaiMed Biologics, stated that the safety and potent viral suppression demonstrated by TMB-365/380 at the CROI conference have been widely recognized by global HIV experts. The combination offers a significant advantage by eliminating the burden of daily medication and reducing the risk of drug-drug interactions commonly seen with small-molecule antivirals. Compared to long-acting regimens from major global pharmaceutical companies, TMB-365/380 offers greater convenience, broader patient eligibility, and requires no pre-treatment resistance genotyping—making it a groundbreaking option for clinical use.
Chang further emphasized that TMB-365/380 is the first and only long-acting intravenous HIV treatment in clinical development composed of two monoclonal antibodies with distinct mechanisms of action. With the potential to become both a "game changer" and a blockbuster therapy, this Phase IIb trial not only reinforces the clinical value of the regimen but also significantly enhances its global visibility. It sets a solid foundation for future strategic partnerships and commercialization. TaiMed is fully committed to becoming a leader in the next generation of HIV therapy.
Resource: 中裕新藥TMB-365/380 IIb期臨床試驗，邁改變HIV治療模式重要里程碑
