TaiMed stated that following the participant’s fourth dose, currently available laboratory results, including key indicators such as HIV-1 RNA (viral load) and CD4+ T Cell Count, have remained within the expected range. These findings suggest sustained viral suppression and continued maintenance of immune function.
TMB-365/380 is one of the most competitive long-acting HIV antibody combination therapies currently under development globally. Designed for administration once every two months (Q2M), the therapy aims to provide a more convenient and adherence-friendly maintenance treatment option for individuals with virologically controlled HIV infection. Compared with certain long-acting therapies currently available or under development, TMB-365/380 may offer the advantage of eliminating the need for viral sensitivity screening, potentially reducing barriers to treatment initiation and expanding the eligible patient population.
TaiMed further noted that the Phase 2b clinical trial recently completed Last Patient In (LPI) enrollment, with a total of 88 participants enrolled, exceeding the original enrollment target of 75 participants. Enrolled participants are currently receiving treatment and follow-up evaluations according to protocol, and the study is progressing as planned.
With the first participant having successfully completed the fourth dose and additional participants entering key evaluation periods, the Company remains cautiously optimistic regarding the interim data readout expected later this year. Should future data continue to demonstrate trends consistent with those observed to date, the results could provide meaningful support for ongoing global licensing discussions, regulatory strategy planning, and a potential application for Breakthrough Therapy Designation (BTD) with the U.S. Food and Drug Administration.
Dr. Jimmy Chang, CEO of TaiMed Biologics, commented:
“The successful completion of the fourth dose by the first participant, together with the continued maintenance of viral suppression, represents an important milestone in the clinical development of TMB-365/380. While the study remains ongoing and we will continue to advance the program cautiously based on scientific evidence and clinical data, the trends observed thus far have further strengthened our confidence in the upcoming interim data readout expected later this year.”
The Company expects to complete the Phase 2b interim data readout between late 2026 and early 2027 and plans to present the study results at the Conference on Retroviruses and Opportunistic Infections (CROI), one of the leading international scientific conferences in the field of HIV research. TaiMed will continue to advance its global development and licensing initiatives, with the goal of delivering next-generation long-acting HIV therapies that offer more convenient and innovative treatment options for patients worldwide.
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