TaiMed Biologics Inc. completed the last patient visit of the sentinel group in the clinical study evaluating the dose levels for the bi-monthly or quarterly injection of long-acting TMB-365/TMB-380 mAb Combination Maintenance Therapy was completed on June 29, 2023 (Last Patient Out). Following two months of review of clinical samples and data analysis, TaiMed plans to hold an investor conference as soon as possible to release the relevant clinical data from the sentinel groups. After that, the core group stage of the clinical study will be carried out, and discussions with potential HIV pharmaceutical companies for licensing/co-development opportunities will be initiated in parallel.

The objective of the Phase 1b/2a study is to evaluate the safety, pharmacokinetics and antiviral activity in HIV patients with bi-monthly or quarterly dosing of the TMB-380/TMB-365 combination as maintenance therapy. The clinical study design consists of two parts: The first part is to dose Sentinel Group patients who receive cART treatment with a single dose of 2400 mg, 3200 mg, or 4800 mg of each antibody intravenously to evaluate safety and PK profile. The second part is to dose Core Group patients with multiple injections of TMB-380/T MB-365 combination injection given q8wks or q12wks as a stand-alone maintenance regimen for six months.

TMB-365 has been confirmed from the previous phase 1 clinical study as long-acting. TMB-380(VRC07-523L), another long-acting monoclonal antibody, was licensed by the US National Institutes of Health (NIH). In a separate phase 1 clinical trial, the NIH has successfully demonstrated the efficacy of TMB-380 in HIV patients who received bi-monthly I.V. infusion.

TMB-365/380 combination therapy is targeted for the first-line maintenance therapy which is significantly different from and much greater than that of the company's first-generation product, Trogarzo, which is an orphan drug and targeted for multi-drug resistant patients. TMB-365/TMB-380 combination is designed as a long-acting combination treatment given bi-monthly or quarterly. If successfully developed, this would be a full stand-alone regimen and would offer patients greater convenience, better tolerability, as well as higher assurance of adherence.

At present, the only approved long-acting HIV maintenance therapy is GSK's Cabenuva (containing two small molecule drugs), which requires two independent bimonthly intramuscular injections of two drugs. Although there are unfavorable factors, such as pain at the injection site, the revenue after the launch is bright, which proves the ardent demand in the market for long-acting HIV new drugs.