pp-158 Concentrate for solution for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: NRG1 gene fusion-positive NSCLC; NRG1 fusion-positive pancreatic ductal adenocarcinoma
Clinical stage: Phase 2 / BLA filed; FDA BLA under review
Modality: Biologic (full-length IgG1 bispecific mAb — Biclonics platform)
Mechanism / Target: HER2×HER3 bispecific — blocks NRG1 (heregulin) binding to HER3; prevents NRG1 fusion-driven HER2/HER3 heterodimerization and downstream PI3K/AKT activation
Route / form: Intravenous infusion
Differentiation: First bispecific antibody for NRG1 fusions; NRG1 fusions are rare genomic drivers (~0.2% NSCLC) with high unmet need; 36% ORR in NRG1+ NSCLC (eNRGy); biomarker-defined population
Manufacturer #15110
Clinical-stage oncology company developing bispecific antibodies using a proprietary Biclonics platform. Advances differentiated multi-target engaging biologics for gastrointestinal and other solid cancers. Wholly owned pipeline with Phase 3 bispecific mAb in head and neck cancer.
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