The multicenter Phase 2b clinical trial is now underway across clinical centers in the United States. It is enrolling people living with HIV who are currently on standard antiretroviral regimens but seeking a more durable and adherence-friendly treatment option. The trial aims to comprehensively evaluate the clinical value of TMB-365/TMB-380 as a long-acting dual antibody regimen, focusing on:
1. Assess safety and tolerability to support long-term administration
2. Evaluate durability of viral suppression
3. Explore a once-every-two-month (q8w) injection long-acting treatment regimen to improve patient adherence and enhance quality of life
Last patient enrollment (LPI) is expected to complete within 1H 2026). A six-month interim analysis is anticipated no later than early 2027. If the interim results mirror the robust Phase 2a findings showing consistent and durable viral suppression-TaiMed plans to seek Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA). The company also intends to work with the FDA to determine the optimal Phase 3 trial design and potential expedited pathways to registration. This strategy aims to accelerate late-stage clinical development and shorten global time-to-market.
TMB-365/TMB-380 continues to demonstrate First-in-Class and Best-in-Class potential, setting itself apart in the global long-acting HIV antibody therapy landscape:
1. Exceptional Phase 2a efficacy: 100% viral suppression with no treatment failures
All participants achieved full viral suppression and maintained durable control, while achieving the required pharmacokinetic (PK) levels for long-acting antibody therapy.
2. Strong safety and tolerability profile
No major drug-related adverse events or severe infusion reactions were observed, supporting its potential for long-term use.
3. World's only HIV antibody therapy that does not require resistance testing
Unlike other long-acting agents or monoclonal antibodies that require tailoring based on the patient’s viral resistance profile, TMB-365/TMB-380 offers universal applicability, without genotypic restrictions – substantially simplifying clinical adoption.
4. World's only complementary dual-antibody long-acting therapy with the potential to replace oral regimens
TMB-365 and TMB-380 work through complementary mechanisms targeting distinct viral entry pathways, providing more complete immune blockade. It is expected to become the world’s first long-acting dual antibody HIV therapy administered once every two months-only six injections per year.
Dr. Jimmy Chang, CEO of TaiMed Biologics, stated:
“The first-patient-in marks the beginning of the critical acceleration phase toward global commercialization for TMB-365/TMB-380. It also highlights the growing global impact of Taiwan’s innovation in HIV therapeutic development. TaiMed will advance the trial in accordance with the highest international standards and work to shorten the time-to-market so that patients worldwide can benefit sooner.”
TaiMed continues to advance the Phase 2b trial rapidly while simultaneously engaging in global licensing and strategic partnering discussions for TMB-365/TMB-380 to support future development and commercialization.
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