BioInvent's BI-1910 Shows Promising Results as Single Agent in Phase 1 Study

BioInvent International AB (BINV), a Swedish biotech company, has announced encouraging data from the Phase 1 study of its monoclonal antibody, BI-1910, as a single agent in patients with advanced solid tumors. The study, an open-label, dose-escalation, multicenter, first-in-human trial, is evaluating the safety, tolerability, and potential signs of efficacy of BI-1910 in this patient population.

BI-1910 is an agonistic anti-TNFR2 antibody, which means it activates the tumor necrosis factor receptor 2 (TNFR2) pathway. This mechanism of action has shown broad anti-tumor activity in preclinical studies, activating T cells and natural killer (NK) cells and demonstrating antitumor activity independent of Fc gamma receptor (FcyR) expression. The Phase 1 study is designed to further investigate these potential benefits in a clinical setting.

The presentation at the Society for Immunotherapy of Cancer (SITC) in November 2023 highlighted the broad anti-tumor activity of BI-1910, suggesting that it may be effective against a wide range of cancer types. This is an important finding, as it could expand the potential patient population that could benefit from this therapy.



The Phase 1/2a clinical trial of BI-1910 is ongoing, with an expected enrollment of approximately 180 patients. The trial is investigating BI-1910 as a single agent and in combination with pembrolizumab, an anti-PD-1 therapy. Exploratory expansion cohorts are planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC), allowing for a more targeted evaluation of BI-1910's potential in these specific cancer types.

The adaptive design of the trial allows for ideal dose optimization, which could help to maximize the efficacy of BI-1910 while minimizing potential side effects. This is an important consideration, as the optimal dose for a new therapy can significantly impact its overall safety and efficacy profile.

In conclusion, the promising data from the Phase 1 study of BI-1910 as a single agent in patients with advanced solid tumors suggests that this therapy has the potential to be an effective treatment option for a wide range of cancer types. The ongoing Phase 1/2a clinical trial will provide more insight into the performance of BI-1910 in combination with other therapies, as well as its potential in specific cancer types. As the trial progresses, investors and the scientific community will be watching closely for updates on this promising therapy.