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TaiMed Biologics Reports IDWeek 2026 Data Highlighting TMB-365 and Its Potential Across Long-Acting HIV Combinations
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October 21, 2026
Phase 1 results demonstrate TMB-365 antiviral activity and tolerability, supporting continued development as a differentiated antibody for combination HIV treatment
Complementary laboratory susceptibility findings support the scientific rationale for the TMB-365/TMB-380 antibody-only maintenance regimen
TaiMed Biologics (TPEX: 4147), a commercial-stage CD4-targeted biologics company advancing antibody-based therapies for long-acting HIV treatment, today announced results from two studies to be presented at IDWeek 2026, October 21-24 in Washington, D.C. The findings highlight TMB-365's own clinical activity and potential as a component of multiple long-acting HIV combinations, alongside laboratory evidence of complementary antiviral susceptibility supporting the company's TMB-365/TMB-380 maintenance regimen.
"These data reinforce our view of TMB-365 as a differentiated antibody with potential across multiple long-acting HIV combinations," said Jimmy Chang, Ph.D., Chief Executive Officer of TaiMed Biologics. "Its host-directed mechanism, antiviral activity and pharmacokinetic profile provide a foundation for exploring combinations with other antibodies and small-molecule antiretrovirals. TMB-365/TMB-380 is our most advanced application of this approach, and the susceptibility findings strengthen the scientific rationale for pairing these two antibodies."
the 1,600-mg cohort remained on stable combination antiretroviral therapy with suppressed HIV. Key findings included:
Antiviral activity: Mean maximum HIV-1 RNA reductions were 1.55 and 1.57 log10 copies/mL at 400 and 800 mg, respectively. Antiviral effects were observed for up to two and four weeks, respectively.
Tolerability: No serious treatment-emergent adverse events, Grade 3 or higher events, or adverse-event-related discontinuations were observed. All 23 treatment-emergent events were mild or moderate; six events in three participants were considered related to TMB-365. No anti-drug antibodies were observed.
Target engagement and dosing potential: In a limited subset, mean CD4 receptor occupancy remained at or above 80% for five to six weeks at 800 and 1,600 mg. The pharmacokinetic findings support further evaluation of higher doses and dosing intervals of eight to 12 weeks.
Resistance observations: No resistance or cross-resistance to TMB-365 or approved entry inhibitors was observed during the study.
The second presentation reports laboratory susceptibility findings for TMB-365 and TMB-380, a broadly neutralizing antibody that targets the CD4-binding site on the HIV envelope protein gp120. Researchers evaluated a panel of 40 HIV pseudotypes: 20 susceptible to TMB-380 and 20 with reduced susceptibility or resistance to TMB-380. They also studied a laboratory-selected virus resistant to LM52, a precursor of TMB-365.
TMB-365 retained activity against variants less susceptible to TMB-380: Its geometric mean IC50 was similar in the TMB-380-susceptible and reduced-susceptibility groups: 0.054 and 0.057 micrograms/mL, respectively. Of the 20 variants with reduced susceptibility or resistance to TMB-380, 19 were susceptible to TMB-365; one showed incomplete neutralization, with a maximum inhibition of 70%.
Complementary activity was also seen in the precursor experiment: The LM52-resistant virus became more susceptible to VRC-07 and VRC-01, antibodies related to TMB-380, supporting the hypothesis that the two mechanisms may cover different viral susceptibility gaps.
An ongoing Phase 2b study is evaluating the regimen against continued oral antiretroviral therapy, with interim results expected by year-end 2026.
https://www.globenewswire.com/news-release/2026/10/21/3385515/0/en/taimed-biologics-reports-idweek-2026-data-highlighting-tmb-365-and-its-potential-across-long-acting-hiv-combinations.html
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