pp-189 Tablets
Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
GMP approvals
PICS
Comments
Indication: Osteosarcoma (recurrent/refractory); multiple solid tumour indications
Clinical stage: Phase 2 — for osteosarcoma (combination with pembrolizumab)
Modality: Small molecule (selective kinase inhibitor)
Mechanism / Target: Dual inhibitor of TGF-β type I receptor (ALK5/TGFβRI) and ALK4; blocks TGF-β-driven immunosuppression in tumour microenvironment and reduces tumour cell proliferation
Route / form: Oral tablet/capsule
Differentiation: First-in-class dual TGFβRI/ALK5 inhibitor; FDA Fast Track + Orphan Drug Designation for osteosarcoma; broad combination potential with checkpoint inhibitors;
Manufacturer #39329
South Korean clinical-stage company using genome-based methods to develop Rx therapeutics for cancer and autoimmune diseases. Pipeline advances novel candidates through domestic and global clinical trials in oncology and immunology therapy areas. Focused on differentiated therapies with novel mechanisms of action addressing significant unmet patient needs.
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