Last Patient In enrolled ahead of schedule; interim analysis anticipated by year-end 2026 to inform plans for the next stage of development
TAIPEI, May 21, 2026 (GLOBE NEWSWIRE) -- TaiMed Biologics (TPEX: 4147) today announced the completion of enrollment in its Phase 2b clinical study evaluating TMB-365/380, a novel investigational long-acting dual-antibody regimen for HIV maintenance therapy. The study reached Last Patient In (LPI) ahead of the planned schedule, marking an important operational milestone for the program.
The Phase 2b study is designed to evaluate the efficacy and safety of TMB-365/380 as an every-two-month (Q2M), first-line HIV maintenance therapy for people living with HIV. With enrollment now complete, participants will continue scheduled follow-up, and TaiMed expects to report an interim analysis by year-end 2026. The Company believes the interim readout may help inform subsequent development and regulatory planning. Preliminary observations from ongoing follow-up show that viral suppression and relevant biomarkers following the first two doses are fully consistent with the Company's expectations.
Subject to continued positive outcomes, the Company plans to submit a Breakthrough Therapy Designation (BTD) application to the U.S. Food and Drug Administration (FDA).
"Completing enrollment ahead of schedule reflects the strong execution of our clinical team and the commitment of our investigators, study sites, and participants," said Dr. Jimmy Chang, Chief Executive Officer of TaiMed Biologics. "The accelerated enrollment highlights strong engagement from clinical sites and interest in Q2M long-acting treatment approaches. We believe TMB-365/380 has the potential to be the first long-acting bNAb combination to demonstrate high rates of viral suppression without the need for susceptibility screening, a distinction that could improve clinical access and patient convenience. We look forward to reporting interim data later this year."
TaiMed estimates peak annual global sales of TMB-365/380 at approximately USD $3-4 billion. TMB-365/380's potential to offer a long-acting, infrequent-dosing treatment option without the need for susceptibility screening may support broad clinical use and differentiation within the evolving HIV treatment landscape.
TaiMed Biologics is exploring potential strategic partnerships, including licensing and co-development opportunities, to support the global development and commercialization of TMB-365/380.
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 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 and is publicly traded on the OTC Market since November 2015, currently part of the MSCI Small Cap Index.
Forward-Looking Statements
This press release contains forward-looking statements, including projections regarding clinical timelines, regulatory submissions, commercial potential, and partnering discussions for TMB-365/380. These statements involve known and unknown risks and uncertainties that could cause actual results to differ materially, including clinical trial outcomes, regulatory decisions, competitive dynamics, and market conditions. TaiMed Biologics undertakes no obligation to update forward-looking statements except as required by applicable law.
Contacts
Investor Relations
Jonathan Ho
jho@taimedbio.com
Media
Sofia Bermudez
LifeSci Communications
sbermudez@lifescicomms.com
