On May 29, 2024 Full-Life Technologies (Full-Life), a fully integrated global radiotherapeutics company, reported it has received clearance of its Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA) for clinical trials of 225Ac-FL-020, its PSMA-targeted radiopharmaceutical for the treatment of metastatic castration-resistant prostate cancer (mCRPC) (Press release, Full-Life Technologies, MAY 29, 2024, View Source [SID1234643818]). The company plans to begin clinical studies in the U.S. and globally in 2024.
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225Ac-FL-020 employs targeted alpha-radiotherapy designed to selectively attack cancer cells, reducing the damage to healthy tissues. In preclinical models, radiolabeled FL-020 displayed a very promising in vivo biodistribution profile, with high and sustained tumor uptake and fast systemic clearance. 225Ac-FL-020 exhibited robust anti-tumor activity in LNCaP xenograft mice, with a favorable safety profile. The upcoming Phase I clinical trial will evaluate the safety, tolerability, and anti-tumor activity of 225Ac-FL-020, and will lay the groundwork for further clinical development, aiming to establish 225Ac-FL-020 as a valuable therapeutic option for patients with mCRPC.
"The IND application clearance is a significant regulatory milestone in our development plan for 225Ac-FL-020", said Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life. "This important step underscores our overall commitment to the therapeutic potential of radiopharmaceuticals and once again highlights the value of the team´s effort, dedication, and cross-functional collaboration. We are excited to initiate the Phase I clinical program, which provides the first opportunity to gather human data on 225Ac-FL-020’s safety and anti-tumor activity."
About 225Ac-FL-020
225Ac-FL-020 is a novel, potential best-in-class, next-generation PSMA-targeting radionuclide drug conjugate (RDC) that will enter global Ph1 clinical studies in 2024. Its targeting vector, FL-020, was discovered using Full-Life’s proprietary UniRDC platform, which enables significant improvement of drug uptake in the tumor while maintaining fast systemic clearance. In pre-clinical models, 225Ac-FL-020 has demonstrated potent anti-tumor activity and a favorable safety profile.