FDA Fast Track for AKY‑1189

The FDA has granted Fast Track designation for AKY‑1189 for adults with locally advanced or metastatic urothelial carcinoma who have progressed on or after prior systemic therapies. AKY‑1189 is a Nectin-4-targeted miniprotein radioconjugate designed to deliver actinium‑225.

The ongoing Phase 1b study of AKY‑1189 (NECTINIUM 2) is enrolling patients with locally advanced or metastatic urothelial cancer, along with several other tumor types that are Nectin-4-expressing. The company also states an expected timing for preliminary results from Part 1 of the study in early 2027.

AKY‑1189 is intended to target Nectin‑4 on tumor cells, with a paired targeting approach with an actinium‑225 radioisotope payload through a miniprotein radioconjugate format. Approximately 80–90% of urothelial cancer patients show positive expression of Nectin‑4.