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pp-186

Solution for infusion

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Third-line (3L) non-small cell lung cancer (NSCLC) — post checkpoint inhibitor (CPI) failure Clinical stage: Phase 3 Modality: Small molecule (telomere-targeting nucleoside analogue) Mechanism / Target: First-in-class telomere-targeting nucleotide; incorporates into cancer cell telomeres generating reactive oxygen species and telomere dysfunction; triggers immunogenic cell death and stimulates anti-tumour immune response; synergises with checkpoint inhibitors Route / form: IV infusion Differentiation: First-in-class telomere-targeting NCE with dual mechanism (direct cytotoxicity + immune activation); Phase 3 THIO-104 initiated Dec 2025 for 3L NSCLC — a population with no approved standard of care; unique mechanism potentiating CPI response;
Manufacturer #39327
US-based clinical-stage immuno-oncology company developing a first-in-class Rx small molecule with a novel mechanism of action. Lead program is in clinical development for a major solid-tumor indication. Listed on a US exchange.

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