BioInvent's TNFR2 Antibody BI-1808 Delivers Meaningful Responses and Immune Activation as Single Agent and in Combination with KEYTRUDA(R) (pembrolizumab) in Advanced CTCL (EHA 2026)

BioInvent will host an in-person KOL lunch briefing (11:45 a.m. - 2:00 p.m. CEST / 5:45 - 8:00 a.m. EDT) in conjunction with EHA 2026 Congress today (virtual event link here)

• BI-1808 monotherapy achieves 40% objective response rate (ORR), including a complete response ongoing at two years, and a 93 % disease control rate (DCR)

50% ORR and 75% DCR in combination with KEYTRUDA^® (pembrolizumab)

BI-1808's Treg-depleting mechanism drives measurable immune activation in patients, confirmed by induction of IL-12, CXCL11 and CCL19 and increased CD8+ T-cell infiltration

Selectively targeting TNFR2 to deplete Tregs and reactivate anti-tumor immunity, BI-1808 holds FDA Fast Track and Orphan Drug designations in CTCL.

LUND, SE / ACCESS Newswire / June 11, 2026 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a leader in the discovery of novel immune-modulatory antibodies, today announced that clinical data from its ongoing Phase 2a trial evaluating BI-1808, its novel anti-TNFR2 monoclonal antibody, in patients with advanced CTCL is being presented at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden in a poster titled "Targeting TNFR2 with BI-1808 with or without pembrolizumab: Immune activation and promising responses in advanced cutaneous T-cell lymphomas (CTCLs)." The poster is being presented by Stefan K. Barta, MD, MS, Associate Professor of Medicine (Hematology-Oncology) and Director of the T-Cell Lymphoma Program at the Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania in Philadelphia, US, and these data underscore BI-1808's potential as both a single agent and combination therapy in this difficult-to-treat cancer with limited therapeutic options.

The poster highlights emerging translational, efficacy and safety findings from the Phase 2a cohort in patients with advanced CTCL, including mycosis fungoides and Sézary syndrome. Patients in these cohorts received BI-1808 either as monotherapy or in combination with MSD's (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab).

Advanced cutaneous T-cell lymphomas are associated with poor long-term outcomes, and patients who relapse after multiple lines of systemic therapy face limited and often short-lived treatment options. Durable responses remain uncommon, underscoring the need for novel therapeutic approaches. TNFR2 is highly upregulated in the tumor microenvironment. With its differentiated mechanism of action, depleting immunosuppressive Treg cells and reprogramming myeloid cells to unleash CD8+ T cell antitumor immunity, BI-1808 offers a promising new approach to cancer immunotherapy. Against this backdrop, the BI-1808 data are particularly significant, demonstrating meaningful and durable clinical activity alongside strong immune activation in a heavily pretreated CTCL population. By selectively targeting TNFR2 and reshaping the tumor immune microenvironment, BI-1808 has the potential to translate immune activation into sustained clinical benefit, both as monotherapy and in combination with pembrolizumab. BI-1808 has received FDA Orphan Drug Designation for T-cell lymphoma and FDA Fast Track Designation for relapsed or refractory MF and SS, as well as a positive opinion from the European Medicines Agency (EMA) for Orphan Drug Designation in CTCL, collectively underscoring the significant unmet medical need and supporting an accelerated path to approval.

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