Core Viewpoint - Aktis Oncology, Inc. has received Fast Track designation from the U.S. FDA for its drug AKY-1189, aimed at treating adult patients with locally advanced or metastatic urothelial cancer who have progressed after prior systemic therapies [1][7] Group 1: Fast Track Designation - Fast Track designation is intended to expedite the development and review of drugs for serious conditions, allowing for more frequent interactions with the FDA and the possibility of rolling submissions for Biologics License Applications [2] - The designation provides Aktis Oncology a unique opportunity to collaborate closely with the FDA to expedite the development of AKY-1189, addressing an unmet medical need in urothelial cancer treatment [3] Group 2: Clinical Trials and Development - Aktis is conducting a multi-site Phase 1b clinical trial (NCT07020117) for AKY-1189, which includes patients with locally advanced or metastatic urothelial cancer and other Nectin-4 expressing tumors [3] - Preliminary results from Part 1 of the trial are expected to be presented in the first quarter of 2027 [3] Group 3: Technology and Pipeline - Aktis has developed a proprietary miniprotein radioconjugate platform that selectively delivers radioisotopes to targeted tumors, maximizing anti-cancer activity while minimizing exposure to normal tissues [4] - The company’s pipeline includes AKY-1189 targeting Nectin-4 and AKY-2519 targeting B7-H3, with potential applications across various tumor types [5]
Aktis Oncology Receives U.S. FDA Fast Track Designation for AKY-1189, a Nectin-4 Miniprotein Radioconjugate