pp-249 Solution for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
Japan
Comments
Indication: Diffuse large B-cell lymphoma (relapsed/refractory DLBCL), mantle cell lymphoma / Clinical stage: Phase 2 (multiple ongoing studies; ORR 21.7% in r/rDLBCL, 41.7% in rituximab-negative patients) / Modality: Engineered toxin body (ETB) / Mechanism & Target: Anti-CD20 single-chain variable fragment genetically fused to Shiga-like Toxin A (SLT-A); CD20-targeted cell internalization / Route & form: Intravenous infusion / Differentiation: Novel direct cell-kill via ribosome inactivation; internalization of non-internalizing CD20 antigen
Manufacturer #39448
| Major research-based pharmaceutical company with pipeline in oncology, immunology, and rare diseases. Develops innovative biologics including engineered toxin conjugates for hematological malignancies. Advances Phase 2 oncology programs through global clinical development and partnerships. |
None