First Patient Enrolled in the Study Evaluating Bi-monthly and Quarterly Dosing of the Long-Acting TMB-365/TMB-380 mAb Combination Maintenance Therapy


After the FDA approval of TaiMed’s IND to evaluate TMB-365/TMB-380 combination therapy in HIV patients, TaiMed announced today that the first patient was successfully enrolled in the study. The objective of the study is to evaluate the safety, pharmacokinetics, and antiviral activity in HIV patients with bi-monthly and quarterly dosing of the TMB-380/TMB-365 combination as maintenance therapy. The target patient group is the first and second-line HIV patients who are already viral load suppressed. In the US, the majority of HIV patients fall in this category.  Both TMB-380 and TMB-365 are long-acting monoclonal antibodies designed for the treatment of HIV patients. If the trial goes well, it is expected that the preliminary results of each dose of the Sentinel Groups will be available in the first half of 2023.

Summary for clinical Study design

      a. 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

      b. Participants and Investigator Sites: A total of 90 participants from approximately 6-8 sites in North America

      c. Primary Objectives

 (a)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.

 (b)Define the pharmacokinetic (PK) profile of TMB-365 and TMB-380 when given q8wks or q12wks in suppressed, cART treated HIV-1 infected participants

 (c)Evaluate the antiviral activity of TMB-365 in combination with TMB-380 as maintenance therapy in suppressed HIV-infected individuals

    d. Study Phase: 1b/2a

    e. Protocol Number: TMB-a21

    f. 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.