BI-1910

BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent’s first-in-class anti-TNFR2 antibody currently in a Phase 1/2a trial. Both monoclonal antibodies were chosen as potential best-in-class, from a large family of binders generated through BioInvent’s proprietary F.I.R.S.T™ technology platform.

Clinical Phase 1/2a single agent study ongoing

As communicated in January 2025, single agent dose escalation of BI-1910 in the ongoing Phase 1 part of the study has successfully been completed without any notable adverse events. Out of the 12 currently evaluable patients, 6 patients display stable disease. Early results indicate favorable pharmacokinetic data and a robust target engagement, with patients in the target dose range showing evidence of induction of T cell proliferation. With the maturation of clinical response and biomarker data from the Phase 1 patients, Phase 2a studying BI-1910 as single agent is planned to start in H1 2025 and will be performed in several tumor types including HCC (hepatocellular cancer) patients.  

The first patients have been enrolled in the Phase 1 Part B study of BI-1910 in combination with pembrolizumab and dose escalation has commenced at a biologically active dose level.

Study design

During the first part of Phase 1/2a study the safety, tolerability, and potential signs of efficacy of BI-1910 as a single agent will be evaluated in patients with advanced solid tumors. In the subsequent part of the Phase 1/2a study, BI-1910 as single-agent (Part A) and in combination (Part B) with the anti-PD-1 therapy pembrolizumab will be evaluated. 

Outlicensing and partnering

In April 2024, BioInvent announced a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate BI-1910 in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase 1/2a clinical trial for the treatment of patients with solid tumors. Under the terms of the supply agreement, MSD will provide pembrolizumab to be used in combination with BI-1910 in the ongoing Phase 1/2a clinical trial.