“Receiving FDA Fast Track Designation for BI-1808 in ovarian cancer is an important milestone that reflects the significant unmet medical need in this difficult-to-treat disease and the strength of the clinical signals we have generated to date,” says Martin Welschof, Chief Executive Officer of BioInvent. “The data we have presented across both high-grade serous and clear cell subtypes underscore the potential of targeting TNFR2 to meaningfully enhance the activity of PD-1 inhibitors in tumors where these agents have historically shown limited benefit. This designation validates our development strategy and strengthens our commitment to advancing BI-1808 as a new treatment option for patients with ovarian cancer.”

Patients with recurrent ovarian cancer progressing after platinum therapy (PROC) face a major unmet need, with pembrolizumab monotherapy historically achieving only an 8% response rate. BI-1808 is a first-in-class antibody targeting TNFR2 that depletes immunosuppressive Tregs, activates myeloid cells and CD8+ T cells in the tumor microenvironment and synergizes with PD-1 blockade. The interim Phase 2a results presented at ASCO 2026 demonstrate that BI-1808 plus pembrolizumab (without chemotherapy) produced a 24% confirmed overall response rate (ORR) and 56% disease control rate (DCR) in this heavily pretreated population, with durable benefit across both high-grade serous and clear cell subtypes, highlighting the potential for a meaningful new option where existing approaches have largely failed. Importantly, prolonged stable disease and partial responses were observed in multiple patients, with several responses ongoing beyond 10 months. Preliminary analyses indicate a median progression free survival (mPFS) of 10.3 months.