#Taiwan #Taipei #TaiMed Biologics #TMB-365 #HIV Treatment

TaiMed Biologics Unveils Transformative Phase 2a Results for Long-Acting HIV Maintenance Therapy

In a groundbreaking development, TaiMed Biologics, a pioneering biotech firm based in Taipei, presented the promising results of its Phase 2a clinical trial for TMB-365/TMB-380 at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025. This innovative dual bNAb therapy marks a significant advancement in HIV treatment, offering a long-acting alternative to the traditional daily oral combination antiretroviral therapy (cART).

The trial results underscore the therapy’s potential, showing that 94% of participants maintained viral loads below 50 copies/ml throughout the treatment period. Only 6% of participants recorded a viral load at the end of the 24 weeks, indicating the therapy’s robust efficacy. Remarkably, no predefined virologic failures occurred, as none of the participants exhibited a resurgence in viral load that would typically indicate treatment failure.

Moreover, the treatment was well tolerated, with no severe adverse effects or infusion reactions reported among participants. The absence of treatment-limiting immune responses adds to the therapy's profile as a safe and effective option for individuals living with HIV.

A standout feature of the TMB-365/TMB-380 regimen is its unique mechanism that eliminates the requirement for prior sensitivity testing. Participants were administered this combination therapy without needing to confirm their susceptibility to the individual bNAbs, vastly improving accessibility for a broader patient demographic. This inclusive approach could help ensure that more people living with HIV can benefit from advanced treatment options.

The pharmacokinetic (PK) and immunological markers from the study further bolster the potential for sustained viral suppression and robust immune function among patients. Although the Phase 2a trial was not a double-blind, placebo-controlled study — thus statistical p-values were not reported — the findings convey a strong forward momentum towards practical application in the field of HIV treatment.

Dr. Jimmy Chang, CEO of TaiMed Biologics, emphasized the significant implications of these results. “We are honored to have our study recognized for a Late-Breaking Presentation at CROI, reflecting the substantial scientific merit and revolutionary nature of our findings,” he stated. “TMB-365/TMB-380 represents the first long-acting monoclonal antibody combination to achieve high viral suppression rates without screening prerequisites, showcasing robust efficacy with wide coverage and low resistance risk.”

Dr. Chang noted that the global market for HIV treatments stands at approximately $30 billion annually, with long-acting therapies currently representing a mere 3% share. However, this figure is anticipated to surge to over 30-40% in the coming years. Given the excellent outcomes of the Phase 2a study, TMB-365/TMB-380 is strategically positioned as a frontrunner in this rapidly expanding market, promising clear advantages over existing long-acting treatment options.

To further enhance the commercialization of TMB-365/TMB-380, TaiMed Biologics is actively seeking strategic partnerships with global pharmaceutical companies. The organization is keen to explore potential collaborations that can assist in advancing the market outreach of this groundbreaking therapy.

Founded in 2007, TaiMed Biologics (4147.TWO) has established itself as a leader in innovative HIV treatment development, launching the world’s first and only FDA-approved monoclonal antibody, Ibalizumab (Trogarzo®), while continuing to spearhead advancements in long-acting biologics and antibody-drug conjugates (ADCs). The company also provides comprehensive contract development and manufacturing organization (CDMO) services, demonstrating a commitment to advancing HIV treatment and research. TaiMed Biologics has been publicly traded on the OTC market since November 2015 and is currently part of the MSCI Small Cap Index.