TaiMed Biologics Announces Publication in The Lancet HIV of Phase 1b/2a Study of Long-Acting Dual-Antibody HIV Maintenance Regimen TMB-365/TMB-380
Further analysis of previously announced Phase 2a results showed 94% of evaluable participants maintained viral
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Further analysis of previously announced Phase 2a results showed 94% of evaluable participants maintained viral suppression through 24 weeks, with no confirmed virologic failures
Study evaluated TMB-365/TMB-380 without pretreatment susceptibility screening and identified pharmacokinetic findings that informed the ongoing Phase 2b study
Publication and presentation at HIV Glasgow 2026 provide peer-reviewed support for TaiMed’s differentiated host- and virus-targeted, all-antibody approach to long-acting HIV treatment
TAIPEI, Taiwan, Nov. 10, 2026 (GLOBE NEWSWIRE) — TaiMed Biologics Inc. (TPEX: 4147), a commercial-stage CD4-targeted biologics company advancing antibody-based therapies for long-acting HIV treatment, today announced the publication in The Lancet HIV of results from a Phase 1b/2a clinical study evaluating TMB-365 in combination with TMB-380 as a long-acting maintenance regimen in people living with HIV who were virologically suppressed on oral antiretroviral therapy (ART). These same findings were also delivered in an oral presentation at this year’s HIV Glasgow meeting held in Glasgow, Scotland, and the scientific article publication is available electronically on The Lancet HIV’s website.
TMB-365 is a long-acting, CD4-directed monoclonal antibody targeting a host receptor required for HIV entry, while TMB-380 is a long-acting broadly neutralizing antibody targeting the CD4-binding site of HIV-1 gp120. The publication, titled “Safety, pharmacokinetics, and antiviral activity of a combination of TMB-365 and TMB-380 in people living with HIV suppressed with antiretroviral therapy in the USA: a phase 1b/2a, open-label, dose-escalation study,” reports safety, pharmacokinetic and antiviral activity results supporting continued clinical development of the dual-antibody regimen.
In the Phase 2a portion of the study, participants discontinued oral ART and received 4,800 mg each of TMB-365 and TMB-380 intravenously every eight weeks for 24 weeks. The study was conducted without pretreatment susceptibility screening for either antibody. Among 17 participants with Week 24 data included in the per-protocol analysis, 16 (94%) maintained HIV-1 RNA below 50 copies/mL. In the intention-to-treat population, 16 of 20 participants (80%) were suppressed at Week 24. No participant met the protocol-defined criteria for confirmed virologic failure.
“This publication provides important peer-reviewed validation of the scientific foundation behind TMB-365/TMB-380 and strengthens our conviction in the potential of a differentiated, antibody-based approach to long-term HIV treatment,” said Jimmy Chang, Ph.D., Chief Executive Officer of TaiMed Biologics. “As people with HIV live longer and increasingly manage multiple chronic conditions and medications, we believe the next generation of long-acting therapies will need to address more than dosing frequency alone. Our goal is to develop an approach that combines durable viral suppression with broad applicability, treatment flexibility and a profile suited to the realities of lifelong HIV care.”
Treatment-emergent adverse events in the Phase 2a study were mild or moderate, with no serious treatment-emergent adverse events, deaths, Grade 3 or 4 treatment-emergent adverse events, opportunistic infections or acute infusion reactions reported. Mean CD4 cell counts remained stable throughout the study without evidence of depletion.
Pharmacokinetic results supported administration every eight weeks and provided insights that have informed subsequent clinical development. Three participants experienced transient HIV-1 RNA elevations of approximately 200–300 copies/mL followed by re-suppression. These participants had body weights above 90 kg and lower TMB-365 exposures. Exploratory analyses identified body weight as a covariate of TMB-365 exposure, supporting the incorporation of bodyweight-based TMB-365 dosing into the subsequent Phase 2b study.
“The ability to maintain viral suppression in most participants for 24 weeks with a complete antibody regimen is encouraging, particularly given that participants were enrolled without pretreatment susceptibility screening,” said Martin Markowitz, M.D., Medical Director of TaiMed Biologics and lead author of the publication. “The ongoing Phase 2b study is designed to build on these findings in a larger population and provide a more rigorous assessment of the regimen’s potential as long-acting maintenance therapy.”
The study also found improvements in selected measures of treatment satisfaction during TMB-365/TMB-380 treatment, including convenience, flexibility, fit with lifestyle and willingness to recommend the treatment to others.
About TMB-365/TMB-380
TMB-365/TMB-380 is an investigational, long-acting dual-antibody maintenance regimen being developed for people living with HIV who are virologically suppressed. TMB-365 is a second-generation, CD4-directed monoclonal antibody and post-attachment inhibitor derived from the scientific foundation of ibalizumab. It binds to domain 2 of the CD4 receptor and is designed to inhibit HIV entry while incorporating modifications intended to improve antiviral activity, stability, resistance profile and pharmacokinetics. TMB-380 is a long-acting broadly neutralizing monoclonal antibody targeting the CD4-binding site of HIV-1 gp120. Together, the two antibodies are designed to provide complementary host- and virus-targeting mechanisms within a complete antibody-based maintenance regimen.
About TaiMed Biologics
Founded in 2007, TaiMed Biologics (TPEX: 4147) is a leading commercial-stage biotechnology company focused on developing innovative therapies for HIV treatment. The company developed ibalizumab (Trogarzo®), the first monoclonal antibody approved by the U.S. FDA for the treatment of HIV-1, and is advancing TMB-365/380, its lead clinical-stage long-acting maintenance therapy candidate for people living with HIV. TaiMed Biologics also offers comprehensive contract development and manufacturing (CDMO) services. Its shares trade on the Taipei Exchange.
Forward-Looking Statements
This press release contains forward-looking statements, including statements about the development and potential of TMB-365, TMB-380, and the TMB-365/TMB-380 regimen. These statements are based on current expectations and involve risks and uncertainties, including those related to clinical development, regulatory review, and commercialization, that could cause actual results to differ materially. Forward-looking statements speak only as of the date of this release, and TaiMed Biologics undertakes no obligation to update them except as required by law.
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