Full-Life Technologies Announces Clearance from FDA of IND Application for 225Ac-FL-020 for the Treatment of Metastatic Castration-Resistant Prostate Cancer

30.05.24 02:00 Uhr

HEIDELBERG, Germany , May 29, 2024 /PRNewswire/ -- Full-Life Technologies (Full-Life), a fully integrated global radiotherapeutics company, today announced 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). The company plans to begin clinical studies in the U.S. and globally in 2024.

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.

About Full-Life Technologies
Full-Life Technologies ("Full-Life") is a fully integrated global radiotherapeutics company with operations in Belgium, Germany, and China. We aim to own the entire value chain for radiopharmaceutical research & development, production & commercialization in order to deliver clinical impact for patients. The Company plans to attack core issues affecting radiopharmaceuticals today through innovative research that targets the treatments of tomorrow. We are comprised of a team of fast-moving entrepreneurs and scientists with a demonstrated track record in the life sciences, as well as radioisotope research and clinical development.

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SOURCE Full-Life Technologies