#Taiwan #Taipei #TaiMed Biologics #HIV Therapy #CROI 2025

TaiMed Biologics Reveals Innovative Results in HIV Treatment

TaiMed Biologics (4147 TWO) has made headlines with the announcement of its latest Phase 2a clinical trial results for its pioneering long-acting HIV therapy, TMB-365/TMB-380, presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2025. The company has demonstrated a promising new alternative to traditional antiretroviral therapy by offering a dual long-acting bNAb regimen, marking a significant step forward in HIV management.

Key Findings from the Phase 2a Trial

One of the most notable findings from the study is the impressive viral suppression achieved among participants. An astounding 94% of those treated maintained their viral load under 50 copies/mL throughout the treatment duration. Only 6% of participants recorded a viral load of 59 copies/mL at the end of a 24-week treatment course, with no documented virological failures as defined by consecutive viral load measurements exceeding 50 copies/mL.

The treatment also exhibited good tolerability, with no serious adverse events reported, and no acute infusion reactions of Grade 3 or 4 were observed. Importantly, participants did not experience any treatment-limiting immune responses, which is a common concern in many therapeutic approaches. This positive outcome is encouraging for future therapies targeting chronic infections like HIV.

Unique Features of TMB-365/TMB-380

What sets TMB-365/TMB-380 apart is its unique requirement of not needing prior susceptibility screening. This is primarily due to the broad activity range and high potency of the antibody combination. Participants did not undergo susceptibility screening for either bNAb, which simplifies treatment access and increases the number of individuals living with HIV who can benefit from this innovative therapy.

Additionally, the pharmacokinetic and immunological markers further bolster the potential for prolonged viral suppression and stable immune function. Although the Phase 2a trial was not a double-blind, placebo-controlled study, the absence of statistically reported p-values does not detract from the compelling results.

Industry Impact and Future Directions

Dr. Jimmy Chang, CEO of TaiMed Biologics, expressed optimism about the findings, saying, "TMB-365/TMB-380 is the first long-acting mAb combination that achieves a high viral suppression rate without screening requirements, while offering robust potency, broad coverage, and a low resistance risk. This regimen aims to reduce the frequency of daily dosing while maintaining treatment efficacy."

The global HIV treatment market is currently valued at around $30 billion annually, with long-acting treatments accounting for a mere 3% of this market share. However, projections suggest that this figure could rise to over 30-40% in the coming years, making the results from this Phase 2a trial particularly crucial as they position TMB-365/TMB-380 at the forefront of this rapidly growing sector.

TaiMed Biologics is actively seeking strategic collaborations with global pharmaceutical partners to support the commercialization of TMB-365/TMB-380, aiming to enhance access to this life-changing therapy for individuals living with HIV.

For further information or collaboration inquiries, contact Jonathan Ho at [email protected]

About TaiMed Biologics

Founded in 2007, TaiMed Biologics (4147.TWO) is a leading commercial-stage biotech company focused on the development of innovative therapies for HIV treatment. The company successfully launched ibalizumab (Trogarzo®), the first and only FDA-approved monoclonal antibody against HIV, and continues to pioneer long-acting biologics and antibody-drug conjugates (ADCs). TaiMed Biologics also offers comprehensive contract development and manufacturing services (CDMO) and is listed on the OTC Market since November 2015, currently part of the MSCI Small Cap index.