Company champions long-acting HIV therapy with new biologic drug TMB-365/380 combination; after favorable results of Phase 1b/2a, company plans to accelerate Phase 2 clincial study to expedite path to market
TAIPEI, Oct. 16, 2023 /PRNewswire/ — TaiMed Biologics, an innovation-driven biotech company dedicated to serving unmet healthcare needs, has announced favorable results and the successful completion of the sentinel group in its phase 1b/2a clinical study evaluating its groundbreaking new treatment for HIV — Long-Acting TMB-365/TMB-380 mAb Combination Maintenance HIV Therapy — initially unveiled at its investor conference on September 6. Following a professional assessment of dosing selection, the company has confirmed the dosages required for the future administration of the two-month combination therapy, thereby achieving its original goals for the 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 has promptly submitted 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 administered injections every two months to obtain a sufficient sample size for Phase 2 clinical study, potentially moving up the start of Phase 3 clinical trials by a year and expediting the drug’s path to market. Additionally, TaiMed is opening discussions with potential HIV pharmaceutical companies for licensing and co-development opportunities.
In the future, the company will continue to assess the feasibility of dosing every three months to extend the duration of action, as well as exploring administration through other routes, such as intravenous infusion, intramuscular, and subcutaneous pathways.
The sentinel group of the Phase 1/2a clinical study has confirmed TMB-365/380 as an ultra-long-acting new drug combination. The target market of TMB-365/380 is first-line maintenance therapy that is entirely different from and much greater than that of TaiMed’s first-generation product, Trogarzo, which is an orphan drug and targets multi-drug-resistant patients. This combination treatment with bi-monthly or quarterly dosing could potentially provide a complete stand-alone regimen, offer patients greater convenience and better tolerability, and ensure adherence. At present, the only approved long-acting HIV maintenance combination therapy is a small molecule drug based combination. There is a great deal of anticipation in the market for the potential of new long-acting HIV drugs. TaiMed’s groundbreaking new drug combination, TMB-365/380, combines two long-acting mAbs with different mechanisms of action for treating HIV, serving as a complete regimen that does not require pairing with additional HIV treatments. In addition, small molecule drugs can have significant side effects, potential drug interactions, and be painful to administer. In this way, the full antibody combination of TMB365/380 has major advantages over currently available drugs.
HIV drugs are a massive market with an annual value of USD 30 billion. Currently, long-acting injections account for only 3%, but are projected to exceed 50% to 60%. TaiMed plans to lead the way in this segment, serving patients and healthcare providers as a vital global leader in the realm of long-acting injections—and HIV treatment overall.
TaiMed Biologics Inc. (4147.TWO) is an innovation-driven biotechnology company dedicated to addressing the unmet medical needs of patients worldwide. Since our establishment in 2007, we have focused on developing groundbreaking antibodies for the treatment of HIV/AIDS. We are proud to have introduced Trogarzo (TMB-355), the first monoclonal antibody (mAb) for HIV/AIDS treatment in the United States. Building upon this remarkable milestone, we are excited to announce our ongoing development of the TMB-365/TMB-380 combination therapy. This promising therapy underscores our unwavering commitment to advancing healthcare with integrity and passion.