pp-219 Concentrate for solution for infusion

Indication: ICB-resistant advanced solid tumours (HCC, melanoma, RCC); R/R DLBCL post-anti-CD19 CAR-T (consolidation) Clinical stage: Phase 2 — CARNATION Phase 2a trial ongoing (R/R DLBCL consolidation post-CAR-T); Phase 2 combination with pembrolizumab (HCC/melanoma/RCC) initiated 2024 Modality: Biological (CD80-IL2v3 immunocytokine fusion protein — NBE) Mechanism / Target: CD80 domain binds CTLA-4 (checkpoint block) and CD28 (T cell co-stimulation); fused to IL-2v3 (IL-2 variant driving T cell and NK cell expansion/activation); dual immune checkpoint-blockade + cytokine stimulation in single bifunctional molecule; monotherapy ORR 18%, DCR 64% in checkpoint-refractory patients (ESMO 2025) Route / form: IV infusion (Q3W) Differentiation: First CD80-IL2 bifunctional immunocytokine; clinical monotherapy activity in ICB-refractory solid tumours; Phase 2a CARNATION trial ongoing for DLBCL consolidation post-CAR-T;