TaiMed Biologics Announces Results from Late-Breaking Phase 2a Data on Long-Acting HIV Maintenance Therapy at CROI 2025

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TMB-365/TMB-380 Combination Demonstrates Viral Suspension Without the Need for Susceptibility Screening

TaiMed Biologics will reshape HIV treatment management and seeks strategic collaborations with global pharmaceutical partners for the commercialization of its long-acting HIV maintenance therapy

TAIPEI, March 17, 2025 /PRNewswire/ -- TaiMed Biologics (4147 TWO), an innovation-driven biotech company, has Phase 2a clinical study evaluating TMB-365/TMB-380 long-acting dual bNAb regimen for HIV maintenance therapy. This regimen, which is the first of its kind, offers a viable alternative to daily oral cART for individuals living with HIV.

Key findings from the trial include durable viral suppression, with 94% of participants maintaining RNA levels below 50 copies/mL throughout the treatment period, while only the remaining 6% of participants recorded viral load of 59 copies/mL at end of 24-week treatment. No pre-defined virologic failure, which were defined as two consecutive viral load measurements above 50 copies/mL.

The treatment was well-tolerated, with no serious adverse events, no Grade 3 or Grade 4, or acute infusion reactions reported. Additionally, no participants experienced treatment-limiting immune responses to the combination therapy.

One of the more remarkable findings of TMB-365/TMB-380 is that it does not require susceptibility screening as the combination's broad breadth of activity and high potency, participants were not pre-screened for susceptibility to either bNAb featured for lowering the barrier to treatment access and ensures a wider range of individuals living with HIV can benefit from the therapy.

Additionally, the pharmacokinetic (PK) and immunological markers also support the potential for long-acting viral suppression and stable immune function. This Phase 2a clinical trial was not a double-blind placebo-controlled study, and therefore, no statistical p-values were reported.

"We are honored that our study was accepted for late-breaking presentation at CROI, highlighting the high scientific merit and groundbreaking nature of our results among numerous research studies, TMB-365/TMB-380 is the first long-acting mAb combination to achieve a high rate of viral suppression without screening requirements with robust potency, broad coverage and low resistance risk The regimen aims to reduce the frequency of daily dosing, while maintaining treatment's efficacy," said Dr. Jimmy Chang, CEO of TaiMed Biologics.

"The global HIV treatment market valued at approximately USD 30 billion annually, with long-acting treatments currently account for only 3% but are projected to increase to over 30-40% in the coming years. The outstanding Phase 2a results position TMB-365/TMB-380 as a frontrunner in this rapidly growing sector, offering clear advantages over existing long-acting treatment options," emphasized by Dr. Jimmy Chang.

TaiMed Biologics is actively seeking strategic collaborations with global pharmaceutical partners to support the commercialization of TMB-365/TMB-380. TaiMed Biologics welcomes opportunities to explore potential collaborations with global pharmaceutical partners to advance the commercialization of TMB-365/TMB-380

For more information, please contact: Jonathan Ho, [email protected].

About TaiMed Biologics

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

SOURCE TaiMed Biologics