BioInvent International AB will present preliminary Phase 1 clinical data for BI-1910, a tumor necrosis factor receptor 2 (TNFR2) agonist, at the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting, despite the company's recent decision to pause the program's development.
The Swedish biotech company announced that updated clinical data from its Phase 1/2a trial (NCT06205706) will be presented as a poster titled "Preliminary Phase 1 results of clinical trial investigating BI-1910, a Tumor Necrosis Factor Receptor 2 (TNFR2) agonist in solid cancer tumor patients" at the meeting scheduled for November 5-9, 2025, at National Harbor, Maryland.
Phase 1 Safety and Efficacy Results
The single agent dose escalation portion of the Phase 1 study was successfully completed without any notable adverse events. Among 12 evaluable patients with advanced solid tumors, six patients displayed stable disease. Early results indicated favorable pharmacokinetic data and robust target engagement, with patients in the target dose range showing evidence of induction of T cell proliferation.
The study evaluated the safety, tolerability, and potential signs of efficacy of BI-1910 as a single agent in patients with advanced solid tumors.
Strategic Development Pause
Despite the positive safety profile, BioInvent announced in August 2025 that it would pause development of BI-1910 following a comprehensive strategic review. The company decided to concentrate resources on advancing BI-1808, its more advanced Phase 2 program, as well as BI-1206, an FcγRIIB-blocking antibody.
BI-1910 is part of BioInvent's tumor-associated regulatory T cells (Treg)-targeting program, where BI-1808 has been prioritized as the most advanced program.
Mechanism and Therapeutic Approach
BI-1910 is an agonistic human IgG2 monoclonal antibody targeting TNFR2, which is particularly upregulated on regulatory T cells within the tumor microenvironment. The receptor has been shown to be important for tumor expansion and survival, representing a promising target for cancer immunotherapy.
The antibody stimulates T cells and enhances the activation of both CD4+ and CD8+ T cells while binding selectively to TNFR2 without inhibiting TNF-α binding. In preclinical models, BI-1910 combined with anti-PD1 therapy showed additive anti-tumor activity, which justified clinical evaluation with pembrolizumab.
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.
Conference Presentation Details
The poster will be presented on November 7-8, 2025, as abstract number 581. The research team includes investigators from multiple institutions, with the abstract scheduled for publication in the Journal for ImmunoTherapy of Cancer (JITC) Abstract Supplement. A link to the supplement will be posted on the SITC website on November 4, 2025.
