pp-203 Tablets

Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
GMP approvals
PICS
Comments
Indication: Recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) Clinical stage: Phase 2 — ongoing (combination with pembrolizumab) Modality: Small molecule (first-in-class dual kinase inhibitor) Mechanism / Target: First-in-class dual inhibitor of TGFβRI (TGF-β type I receptor) and VEGFR2 (vascular endothelial growth factor receptor 2); simultaneously blocks TGF-β-driven immunosuppression AND tumour angiogenesis in a single oral agent Route / form: Oral tablet/capsule Differentiation: First-in-class dual TGFβRI+VEGFR2 kinase inhibitor; unique bifunctional mechanism targeting both immune checkpoint (TGF-β) and angiogenesis (VEGF) simultaneously; oral administration; Phase 2 for R/M HNSCC with pembrolizumab; pembrolizumab = combination trial partner only (not co-development of tosposertib);
Manufacturer #39340
Publicly listed South Korean clinical-stage biopharmaceutical company developing Rx innovative therapeutics for rare diseases including NASH, fibrosis, and ophthalmic conditions. Multiple injectable and oral candidates are advancing through Phase 1/2 clinical stages with global development strategy. Committed to addressing critical unmet medical needs through international clinical partnerships.
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