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1 products found

pp-222

Tablets

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA, Taiwan
Comments
Indication: Advanced/metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations Clinical stage: Phase 2 cohort enrolling Modality: Small molecule (mutant-selective irreversible HER2 exon20 TKI — NCE) Mechanism / Target: Selective irreversible covalent inhibitor of HER2 kinase harbouring exon 20 insertion mutations; superior selectivity for HER2 exon20 mutant over wild-type HER2 and EGFR; prevents ABCG2 (breast cancer resistance protein) transporter-mediated drug efflux — mechanism overcoming a primary resistance pathway; blocks tumour cell proliferation driven by constitutively active HER2 exon20 insertions Route / form: Oral tablet or capsule Differentiation: Mutant-selective HER2 exon20 TKI with anti-ABCG2 efflux resistance advantage;
Manufacturer #39358
Taiwan-based clinical-stage biotech founded in 2017 dedicated to Rx precision oncology drug development. Advances a pipeline of novel antibody-based therapeutics targeting solid tumors, with an A+ financing round recently completed to advance ABT-301 into Phase II. Committed to international clinical development and R&D innovation for cancer patients globally.

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