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.

Status

Clinical Phase 1/2a study ongoing

BI-1910 second anti-TNFR antibody is a TNFR2 agonist, currently enrolling patients in the monotherapy cohort of the Phase 1/2a study in patients with advanced solid tumors.

Phase 1 dose escalation of single agent BI-1910 is ongoing and has reached the fifth planned dose level without any notable adverse events observed. The prespecified target dose range with robust target occupancy has been reached, and evidence of immune activation has been observed.

Dose escalation will continue for exploration of a wide range of dose-safety/tolerability margin, and is expected to complete before year-end 2024, leading to opening Phase 2a with BI-1910 monotherapy in NSCLC in first half of 2025. Phase 1 Part B dose escalation of BI-1910 in combination with pembrolizumab is expected to commence Q4 2024.

The Phase 1/2a study aims to establish the safety/tolerability profile, pharmacokinetics, pharmacodynamics and preliminary efficacy of BI-1910 as monotherapy and in combination with pembrolizumab. Phase 2a will be performed in advanced/metastatic NSCLC and HCC patients in parallel cohorts. Safety and efficacy of BI-1910 as monotherapy and in combination will be evaluated at two separate dose levels for dose optimization.

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. The study is expected to enroll a total of approximately 180 patients.

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