BioInvent International AB presented promising population modeling data for its anti-TNFR2 antibody BI-1910 at the Population Approach Group in Europe (PAGE) 2025 meeting in Thessaloniki, Greece. The Swedish biotech company successfully developed a population model to characterize the drug candidate's pharmacokinetics and pharmacodynamics across a broad range of doses, providing critical insights to support dose selection for upcoming Phase 2a studies.
Clinical Progress and Efficacy Signals
The Phase 1 dose escalation study of BI-1910 as a single agent in patients with advanced solid tumors has been successfully concluded. In January 2025, BioInvent reported stable disease for six out of 12 evaluable patients in the single agent dose escalation Phase 1 study. The data indicated a favorable pharmacokinetic profile and robust target engagement, with patients in the target dose range demonstrating induction of T cell proliferation.
"The indicated wide therapeutic dose range of BI-1910 could bring multiple benefits to the product in terms of clinical utility, safety and market potential," said Martin Welschof, Chief Executive Officer of BioInvent. "We look forward to continuing the rapid progress including initiation of both the combination and single agent parts of the Phase 2a study during the second half of this year."
Dual Development Strategy
BI-1910 is being investigated through a comprehensive dual approach as both a single agent and in combination with KEYTRUDA® (pembrolizumab). The Phase 1/2a study included two parts: Part A evaluated BI-1910 as a single agent in patients with advanced solid tumors, while Part B assessed the combination with MSD's anti-PD-1 therapy pembrolizumab. Both Phase 1 components have been successfully completed.
The upcoming Phase 2a study will maintain this dual strategy. Part A will evaluate BI-1910 as a single agent across several tumor types, including hepatocellular cancer (HCC) patients, while Part B will assess the combination with pembrolizumab in the same indications. Both studies are planned to initiate during the second half of 2025.
Model-Informed Drug Development
The poster presentation at PAGE 2025, titled "A population modelling framework to support early clinical development of BI-1910, an agonist monoclonal antibody for tumor necrosis factor 2," highlights the company's model-informed approach to clinical development. This population modeling framework will support dose selection for the upcoming Phase 2a studies.
"We are very pleased to be showcasing our anti-TNFR2 program BI-1910 at this year's PAGE meeting, and in particular how model-based methods derived from clinical data can be used to support early clinical development and dose selections for upcoming studies," Welschof noted.
Differentiated Mechanism of Action
BI-1910 offers a differentiated, agonist approach to cancer treatment compared to BI-1808, BioInvent's first-in-class anti-TNFR2 antibody currently in Phase 1/2a development. Both monoclonal antibodies were selected as potential best-in-class candidates from a large family of binders generated through BioInvent's proprietary F.I.R.S.T™ technology platform.
BioInvent International AB is a clinical-stage biotech company focused on discovering and developing novel and first-in-class immune-modulatory antibodies for cancer therapy. The company currently has five drug candidates in six ongoing clinical programs in Phase 1/2 trials for treating hematological cancer and solid tumors.
