Aktis Oncology announces FDA clearance of Investigational New Drug applications for AKY-2519

CAR-T Digest - August 2020

30 March 2026: Aktis Oncology announces FDA clearance of Investigational New Drug applications for AKY-2519

Aktis Oncology’s radiopharmaceutical candidate AKY-2519 has received IND clearance from the U.S. FDA, enabling the program to move into clinical development
Following this clearance, AKY-2519 is expected to enter a Phase 1b clinical trial in mid-2026, where its safety and early anti-tumor activity will be evaluated
This marks an important step forward as the company looks to expand the use of targeted radiopharmaceuticals in solid tumors, where treatment options remain limited for many patients
AKY-2519 is a B7-H3-targeting miniprotein radioconjugate, designed to deliver a potent alpha-emitting radioisotope directly to tumor cells
With clinical testing set to begin, AKY-2519 adds to the growing momentum in next-generation radiopharmaceuticals, aiming to improve targeted treatment approaches across multiple solid tumors