pp-157 Concentrate for solution for infusion
Dossier type
CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Recurrent/metastatic HNSCC (1L in combination with pembrolizumab; 2L monotherapy or combinations)
Clinical stage: Phase 3 — LiGeR-HN-01 (1L), LiGeR-HN-02 (2L) trials ongoing
Modality: Biologic (full-length IgG1 bispecific mAb — Biclonics platform)
Mechanism / Target: Simultaneously targets EGFR (overexpressed in HNSCC) and LGR5 (Wnt pathway/cancer stem cell marker) — induces internalisation and degradation of EGFR, blocking tumour cell proliferation and stem cell renewal
Route / form: Intravenous infusion
Differentiation: Dual target engagement provides deeper/more durable EGFR inhibition vs cetuximab; LGR5 co-targeting may reduce resistance; Phase 2 data showed 37% ORR and 16-month OS in 2L HNSCC
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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