BioInvent International AB announced the presentation of a poster highlighting the model-informed early clinical development of the company's anti-TNFR2 program BI-1808 at the Population Approach Group in Europe (PAGE) 2024 meeting, being held in Rome, Italy from June 26 to 28, 2024. BI-1808 could represent a new class of immunomodulatory agent with the potential to improve efficacy of cancer therapy. As earlier communicated, initial efficacy and safety data from the ongoing Phase 1/2a study show so far: One complete response (CR), one partial response (PR) that is still improving, and nine patients with stable disease (SD) of 26 evaluable patients in the single agent arm of BI-1808; Promising signs of efficacy and favorable safety profile in the Phase 1 dose escalation part studying BI-1808 in combination with KEYTRUDA® (pembrolizumab).

Poster summary: The objective was to characterize the population pharmacokinetics (PK), receptor occupancy (RO), and concentrations of the target engagement biomarker soluble tumor necrosis factor receptor 2 (sTNFR2) at different BI-1808 doses, to support the dose selection for the dose expansion trial. Data and methods: Data was available from patients in the ongoing Phase 1/2a dose escalation trial. Model building and application proceeded in a sequential manner: Development of a joint PK-RO model to simultaneously characterize BI-1808 concentrations and TNFR2 receptor occupancy.

Extension of the PK-RO model with a sTNFR2 PD model. Typical value simulations for RO as well as PK and sTNFR2 (not shown) considering different doses and dosing frequencies. Conclusions: A simultaneous model of the BI-1808 PK, RO, and sTNFR2 successfully explained the observed profiles across a wide dose range.

Simulations provided insights into the expected PK, RO, and sTNFR2 levels across potential dose levels and dosing frequencies and will support the selection of doses for further exploration. Poster Title: Model-informed early clinical development of BI-1808, a novel monoclonal antibody to tumor necrosis factor receptor 2; Abstract Number: 10786; Session: Drug/Disease Modelling - Oncology; Date: June 27, 2024; Time: 9:50 - 11:20 AM CEST.