BioInvent International AB announced it has received Investigational New Drug (IND) approval for the monoclonal antibody BI-1910, which will now become its second anti-tumor necrosis factor receptor 2 (TNFR2) program to enter clinical development. BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent's first-in-class anti-TNFR2 antibody which is 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. Using a surrogate monoclonal antibody to BI-1910 in experimental models, BioInvent has been able to take a deep dive into the search for pharmacodynamic biomarkers. These PD markers will be explored in patients and will likely provide guidance during clinical development.

The planned Phase 1/2a clinical study will be conducted in the US and Europe and will have an innovative, adaptive design to allow for ideal dose optimization. Exploratory cohorts are planned in hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC) and initial investigations will be as both a single agent and in combination with pembrolizumab.