TaiMed Biologics announced on the 13th that its Core Group II(a) clinical trial of TMB365/380 has achieved early completion of enrollment. Data analysis is expected to be available by the end of 2024 to early 2025. Internally, following the II(b) clinical trial, negotiations for licensing agreements with major international pharmaceutical companies will be actively initiated.
The Core Group II(a) clinical trial of TMB365/380 was planned to include 20 subjects. Enrollment of the first subject began in late March. All subjects were enrolled by last Friday (May 10). Excluding holidays such as Easter and other US holidays within the schedule, the enrollment for II(a) was completed in just over 40 working days, significantly exceeding expectations.
TaiMed Biologics stated that the objective of the II(a) trial is to use the TMB-380/TMB-365 combination as maintenance therapy, employing an every 8-week dosing regimen, to obtain efficacy, safety, and other pharmacokinetic data for the dual monoclonal antibody combination. The target population for treatment is frontline or second-line HIV-infected patients whose viral loads are currently suppressed, estimated to be over 600,000 in the United States alone. If the trial proceeds smoothly, data analysis is expected by the end of 2024 to early 2025.
TMB365/380 has been granted Fast Track Designation by the FDA. It is currently the only combination of monoclonal antibodies with different mechanisms. Its global competitive positioning is based on being both first-in-class and best-in-class. The acquisition of efficacy data upon completion of the II(a) clinical trial is a critical milestone closely monitored by major international pharmaceutical companies. TaiMed Biologics will be able to further engage in discussions regarding licensing and commercial cooperation with these companies.
Furthermore, TaiMed Biologics also plans to actively initiate negotiations for licensing agreements with major international pharmaceutical companies during the II(b) trial.
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