TaiMed Biologics, a pioneering biotechnology firm, has marked a significant milestone in the fight against HIV. The company announced positive results from its Phase 1b/2a clinical trial for its innovative Long-Acting TMB-365/TMB-380 mAb Combination Maintenance HIV Therapy.
This breakthrough therapy, first introduced to stakeholders at an investor conference in September, aims to reshape the HIV treatment landscape. The sentinel group of the study confirmed the efficacy of the TMB-365/380 combination, identifying it as an ultra-long-acting treatment.
Established in 2007, TaiMed Biologics Inc. (4147.TWO) has consistently been at the forefront of developing innovative antibodies to combat HIV/AIDS. With their first HIV/AIDS monoclonal antibody, Trogarzo (TMB-355), already making waves in the U.S., the company’s newest combination therapy, TMB-365/TMB-380, stands as a testament to their unwavering commitment to elevating global healthcare standards.
Highlighting its differentiating factor, TaiMed’s TMB-365/380 targets first-line maintenance therapy, presenting a notable shift from the company’s initial product, Trogarzo, which is directed towards multi-drug-resistant patients. With its bi-monthly or quarterly dosing potential, the combination therapy may offer an all-inclusive stand-alone regimen. This could spell heightened convenience, enhanced tolerability, and consistent adherence for patients.
At a time when the only FDA-approved long-acting HIV maintenance therapy is based on a small molecule drug combination, TMB-365/380 offers a promising alternative. The combination features two long-acting mAbs, negating the need for supplementary HIV treatments. Considering that small molecule drugs often come with notable side effects and administration challenges, TaiMed’s fully-antibody combination may well be a game-changer.
With the global HIV drug market valued at a staggering USD 30 billion annually and long-acting injections accounting for a meager 3%—but with projections to surge to 50% to 60%—TaiMed’s innovation is timely. The company’s clear intention is to spearhead this burgeoning segment, fortifying its position as a global front-runner in long-acting injections and overall HIV treatment.
In light of these encouraging findings, TaiMed has fast-tracked its efforts, submitting a revised protocol to the U.S. FDA for the core group clinical trial. The revised approach aims to consolidate participants and administer bi-monthly injections to ensure a substantial sample size for the Phase 2 clinical study. This strategy could accelerate the initiation of Phase 3 clinical trials by a year, hastening the drug’s journey to the global market.
Furthermore, TaiMed is entering dialogues with leading HIV pharmaceutical entities to explore licensing and co-development avenues. The company also hinted at assessing other administration methods, such as intravenous infusions and intramuscular and subcutaneous pathways, in the future.