TaiMed Biologics Inc. officially announce the successful completion of the sentinel group in the phase 1b/2a clinical study evaluating Long-Acting TMB-365/TMB-380 mAb Combination Maintenance HIV Therapy. Following a professional assessment of dosing selection, the company have confirmed the doses required for the future administration of the two-month combination therapy, thereby achieving the predetermined goals of this sentinel group clinical trial. To ensure the success of future clinical trials, product positioning in the market, and expedite the overall clinical trial timeline, the company will promptly submit a revised protocol to the U.S. FDA for the core group clinical trial.

In the modified protocol, all participants in the core group trial will be combined and executed injections every two months to obtain a sufficient sample size for Phase 2 clinical trials, this might accelerate entry into Phase 3 clinical trials by one year and expedite the drug's path to market. Additionally, discussions with potential HIV pharmaceutical companies for licensing/co-development opportunities will be progressed in parallel. Summary of clinical Study design Title: A Phase 1b/2a Dose Escalation Study of the Safety, Pharmacokinetics and Efficacy of the Combination of TMB-365 and TMB-380 in HIV-1 Infected Individuals Suppressed with Combination Antiretroviral Therapy.

Participants and Investigator Sites: A total of 90 participants from approximately 6-8 sites in North America. Primary Objectives: Evaluate the safety and tolerability of various doses and dosing regimens of IV infusions of TMB-365 and TMB-380 given q8wks or q12wks in suppressed, cART treated HIV-1 infected participants. Define the pharmacokinetic (PK) profile of TMB-365 and TMB-380 when given q8wks or q12wks in suppressed, cART treated HIV-1 infected participants.

Evaluate the antiviral activity of TMB-365 in combination with TMB-380 as maintenance therapy in suppressed HIV-infected individuals. Study Phase: 1b/2a. Protocol Number: TMB-a21.

Clinical Study Design: This is an adaptive dose-escalation study of various dosing regimens of TMB-365 and TMB-380 administered intravenously to HIV-1 infected individuals suppressed on combination antiretroviral therapy (cART). Each cohort of this adaptive study design will be comprised of Sentinel Groups (N=10) and Core Groups (N=20). Sentinel Groups: Sentinel Groups will be comprised of 10 cART suppressed HIV-1 infected volunteers who continue on current cART and receive single intravenous doses of 2400 mg, 3200 mg, 4800 mg of each antibody.

Core Groups: Safety and PK results obtained in Sentinel Group participants will inform the conduct of Core Groups. Core Groups will be comprised of 20 cART suppressed HIV-1 infected volunteers who receive multiple IV doses of the combination of TMB-365 and TMB-380 q8wks or q12wks as a stand-alone maintenance regimen for 6 months. Results of clinical study: The results of this sentinel group clinical trial indicate that safety and tolerability have been excellent, meeting expectations.

In this sentinel group clinical trial, pharmacokinetic (PK) analysis was conducted for TMB-365/TMB-380 combination therapy at different doses. The trial results analysis showed that the duration of action and dose levels were as expected. The company has confirmed the relevant dosages for TMB-365 and TMB-380 combination therapy administered every two months for the next phase of the core group trial.

In the future, company will continue to assess the feasibility of dosing every three months to extend the duration of action as well as administration through other routes of administration. (such as intravenous infusion, intramuscular, subcutaneous). The aforementioned phased development strategy is modeled after GSK's Cabenuva, which initially applied for FDA approval in the United States for monthly injection and then, one year later, applied for approval of a two-month injection.