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TaiMed Biologics' Breakthrough in HIV Treatment

TaiMed Biologics, a pioneering biotechnology firm, recently made headlines at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025 by revealing significant results from their Phase 2a clinical study of TMB-365/TMB-380. This innovative long-acting dual broadly neutralizing antibody regimen represents a revolutionary step in the management of HIV maintenance therapy, offering an alternative to the traditional daily oral combination antiretroviral therapy (cART).

Key Findings from the Phase 2a Trial

The data presented highlighted remarkable outcomes, with 94% of study participants achieving sustained viral suppression, maintaining RNA levels below 50 copies/mL throughout the treatment duration. In stark contrast, just 6% registered a viral load at the end of the 24-week treatment, demonstrating the regimen's effectiveness. Impressively, there were no instances of predefined virologic failure, defined as two consecutive viral load readings exceeding 50 copies/mL.

Moreover, the therapy showcased an excellent safety profile, as there were no serious adverse events or severe infusion reactions. Participants displayed no Grade 3 or 4 adverse effects, nor did they experience any treatment-limiting immune responses. Such findings underscore the potential of TMB-365/TMB-380 as a well-tolerated option for individuals living with HIV.

A Game-Changer: No Susceptibility Screening Required

One of the standout aspects of TMB-365/TMB-380 is its innovative design, which does not mandate susceptibility screening. This means that individuals are not required to undergo pre-screening to determine their susceptibility to the components of the regimen, thereby broadening access to treatment. The combination’s high potency and wide-ranging efficacy make it suitable for a more diverse population living with HIV.

Additionally, pharmacokinetic and immunological data support the potential for sustained viral suppression as well as stable immune function in patients. Although this Phase 2a trial was not designed as a double-blind placebo-controlled study, its findings speak volumes about the promise held by this treatment.

Industry Impact and Future Collaboration

Dr. Jimmy Chang, CEO of TaiMed Biologics, expressed pride in having the research recognized at CROI, affirming the study’s high scientific value. He highlighted TMB-365/TMB-380 as the first long-acting monoclonal antibody combination to achieve a significant level of viral control without the hurdles of screening requirements. This therapy aims to simplify HIV treatment by minimizing the need for daily dosages while retaining its effectiveness.

The global HIV treatment market is valued at about USD 30 billion annually; however, long-acting therapies, which currently account for only 3% of this market, are expected to surge to 30-40% in the coming years. With such promising Phase 2a results, TMB-365/TMB-380 positions itself as a leading contender in this expanding sector, promising clear advantages over existing long-acting treatment options.

Recognizing the potential of TMB-365/TMB-380, TaiMed Biologics is actively seeking strategic partnerships with global pharmaceutical companies to facilitate its commercialization. The company is keen to explore collaboration opportunities that will help bring this promising therapy to market and make a difference for individuals living with HIV.

About TaiMed Biologics

Founded in 2007, TaiMed Biologics (4147.TWO) stands as a trailblazer in biotech innovation, specifically in developing therapies for HIV treatment. The company is notable for launching ibalizumab (Trogarzo®), the world’s first FDA-approved monoclonal antibody for HIV. In addition to its core therapeutic advancements, TaiMed Biologics offers extensive contract development and manufacturing services and has been publicly traded since 2015.

For further inquiries, please contact Jonathan Ho at [email protected].