Aktis Oncology (AKTS) said late Monday that the US Food and Drug Administration cleared its investigational new drug applications, allowing it to proceed to a phase 1b clinical trial of AKY-2519, expected to begin in mid-2026.
AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in multiple solid tumor types including prostate and lung cancers, the company said.
Results from the clinical imaging and dosimetry assessment of AKY-2519 in patients with various solid tumors are expected in mid-2026, the company added.
The company said its cash position will fund its operations into 2029.
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