Discovery of TYRA-300: First Oral Selective FGFR3 Inhibitor for the Treatment of Urothelial Cancers and Achondroplasia

J Med Chem. 2024 Sep 26;67(18):16737-16756. doi: 10.1021/acs.jmedchem.4c01531. Epub 2024 Sep 11.

Abstract

Activating FGFR3 alterations have been identified in up to 15-20% of muscle-invasive bladder cancer and metastatic urothelial carcinoma (mUC), and as high as 80% in nonmuscle invasive bladder cancers. FGFR3 germline mutations have also been associated with a variety of skeletal dysplasias. Achondroplasia, the most common form of dwarfism in humans, results from a G380R mutation in FGFR3. The pan-FGFR inhibitor erdafitinib was approved for the treatment of mUC with FGFR3 alterations but is limited due to FGFR isoform off-target toxicities and the development of on-target gatekeeper resistance mutations. TYRA-300 (22) was conceived using a structure-based approach as a potent FGFR3-selective inhibitor to avoid the toxicities associated with inhibition of FGFR1, FGFR2, and FGFR4, and to be agnostic for the FGFR3 gatekeeper mutations. TYRA-300 is being evaluated in a Phase 1 clinical trial in urothelial cancers and solid tumors, with intention to initiate Phase 2 studies in urothelial cancers and achondroplasia.

MeSH terms

  • Achondroplasia* / drug therapy
  • Administration, Oral
  • Animals
  • Antineoplastic Agents / chemistry
  • Antineoplastic Agents / pharmacology
  • Antineoplastic Agents / therapeutic use
  • Drug Discovery
  • Humans
  • Protein Kinase Inhibitors / chemistry
  • Protein Kinase Inhibitors / pharmacology
  • Protein Kinase Inhibitors / therapeutic use
  • Rats
  • Receptor, Fibroblast Growth Factor, Type 3* / antagonists & inhibitors
  • Receptor, Fibroblast Growth Factor, Type 3* / genetics
  • Receptor, Fibroblast Growth Factor, Type 3* / metabolism
  • Structure-Activity Relationship
  • Urinary Bladder Neoplasms* / drug therapy
  • Urinary Bladder Neoplasms* / pathology

Substances

  • Receptor, Fibroblast Growth Factor, Type 3
  • FGFR3 protein, human
  • Antineoplastic Agents
  • Protein Kinase Inhibitors