BioInvent International AB has announced promising early data from its Phase 1 study of BI-1910 as a single agent in patients with advanced solid tumors. The dose-escalation phase (Part A) of the trial has been completed, demonstrating a biologically active dose level with stable disease observed in six out of twelve evaluable patients. Notably, no significant adverse events were reported, even at the highest doses tested.
The ongoing Phase 1 study is now proceeding with Part B, which evaluates BI-1910 in combination with pembrolizumab (Keytruda), Merck's anti-PD-1 therapy. This combination arm aims to assess the potential additive effects of targeting both TNFR2 and PD-1 pathways in cancer immunotherapy.
Validating TNFR2 as a Target
These findings, coupled with previously reported data on BioInvent's other anti-TNFR2 antibody, BI-1808, strengthen the rationale for TNFR2 as a novel immune checkpoint. BI-1808 has shown deepening responses in cutaneous T-cell lymphoma (CTCL) patients, further supporting the development of TNFR2-targeted therapies.
Martin Welschof, CEO of BioInvent, stated, "The encouraging data generated during the year by both our BI-1808 and BI-1910 antibodies further validate TNFR2 as a promising new immune checkpoint and supports our strategy to develop both our assets in the TNFR2 program as we aim to provide new treatment solutions for cancer patients."
Clinical Trial Details and Next Steps
The Phase 1 study of BI-1910 is a dose-escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of the antibody in patients with advanced solid tumors. Early results indicate favorable pharmacokinetic data and robust target engagement, with evidence of T cell proliferation in patients receiving the target dose. Based on these encouraging results, BioInvent plans to initiate a Phase 2a study of BI-1910 as a single agent in the first half of 2025. This study will focus on specific tumor types, including hepatocellular carcinoma (HCC).
BI-1808 Update
BioInvent also provided an update on BI-1808, reporting that in the monotherapy study, three out of four evaluable patients with CTCL who had progressed after standard therapy achieved a partial response (PR). These responses are ongoing and deepening. Furthermore, a patient who previously exhibited a PR continues to improve after more than 80 weeks. Data presented at ASCO 2024 on BI-1808 showed one complete response (CR), one PR, and nine patients with stable disease (SD) observed in 26 evaluable patients.
The Phase 2a combination arm of the study evaluating BI-1808 with pembrolizumab is ongoing, with patient enrollment in the ovarian cancer cohort underway. Phase 2a data from this combination arm is expected to be presented in H2 2025.
