TaiMed Biologics Unveils Groundbreaking Phase 2a Results for Long-Acting HIV Therapy

TaiMed Biologics, a pioneering biotech firm committed to innovative treatment solutions, has recently announced the results of its Phase 2a clinical study focused on the TMB-365/TMB-380 long-acting dual broadly neutralizing antibody (bNAb) combination for HIV maintenance therapy. This groundbreaking regimen is setting a new benchmark in HIV treatment options by presenting a viable alternative to the conventional daily oral combination antiretroviral therapy (cART).

The trial's findings are remarkable, showcasing durable viral suppression in an impressive 94% of participants, who maintained their RNA levels below 50 copies/mL throughout the study period. Just 6% of participants exhibited a viral load of 59 copies/mL by the end of the 24-week treatment. Notably, the study reported no instances of predefined virological failure, which had been identified as two consecutive viral load measurements exceeding 50 copies/mL.

Importantly, the safety profile of TMB-365/TMB-380 was robust—participants tolerated the treatment well, experiencing no serious adverse events or severe reactions. Additionally, there were no reports of treatment-limiting immune responses, which gives confidence in the regimen's safety and applicability.

One of the standout features of the TMB-365/TMB-380 regimen is its broad-spectrum efficacy. Unlike traditional therapies, this combination does not necessitate prior susceptibility screening, allowing for greater accessibility. With its unique mechanism, the therapy holds promise for a wider array of individuals living with HIV, lowering barriers to treatment access significantly. This approach not only enhances the likelihood of successful management but also aligns with the growing demand for significant advancements in HIV treatment.

The preliminary data indicates that pharmacokinetic (PK) and immunological markers reinforce the potential for long-term viral suppression alongside stable immune function. As Dr. Jimmy Chang, CEO of TaiMed Biologics, highlighted, the acknowledgment of this study at CROI further underlines its substantial scientific merit and innovative nature amidst a competitive research landscape. "TMB-365/TMB-380 is the first long-acting monoclonal antibody combination to achieve significant viral suppression rates without screening requirements. We aim to not only revolutionize daily treatment dosing frequency but also maintain the therapy's therapeutic efficacy," he said.

The global HIV market is estimated at around USD 30 billion annually, though current long-acting treatment options comprise only about 3% of that market. However, projections suggest that this figure could skyrocket to between 30% to 40% in the near future. With its promising results from the Phase 2a trial, TMB-365/TMB-380 stands poised to take the lead in this rapidly evolving sector, delivering distinct advantages over existing long-acting treatment alternatives.

To scale its impact and facilitate commercialization of the TMB-365/TMB-380 regimen, TaiMed Biologics is actively pursuing strategic partnerships with global pharmaceutical companies. They are keen on fostering collaborations that can help bring their innovative solution to patients who need it most. For those interested in partnerships, Jonathan Ho is the point of contact and can be reached via email.

Founded in 2007, TaiMed Biologics has continuously driven innovation in HIV treatment, culminating in the launch of ibalizumab (Trogarzo®)—the world’s first and only FDA-approved monoclonal antibody for HIV. With a synergy of potent long-acting biologics and antibody-drug conjugates (ADCs), TaiMed remains at the forefront of the biopharmaceutical sector, committed to evolving HIV care for a future where effective treatment is accessible to everyone.