FDA Clears IND for 225Ac-FL-020 in Metastatic Prostate Cancer

HEIDELBERG, Germany, May 29, 2024 — Full-Life Technologies (Full-Life), a global leader in radiotherapeutics, has announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) Application. This clearance allows Full-Life to begin clinical trials for its novel radiopharmaceutical, 225Ac-FL-020, aimed at treating metastatic castration-resistant prostate cancer (mCRPC). The clinical trials are expected to commence in the U.S. and other regions globally in 2024.

225Ac-FL-020 is designed to use targeted alpha-radiotherapy to precisely attack cancer cells while minimizing damage to surrounding healthy tissues. Preclinical studies have shown that radiolabeled FL-020 has a promising biodistribution profile, characterized by high and sustained tumor uptake and rapid systemic clearance. In animal models, specifically LNCaP xenograft mice, 225Ac-FL-020 demonstrated significant anti-tumor activity and a promising safety profile. The forthcoming Phase I clinical trial will assess the safety, tolerability, and anti-tumor efficacy of 225Ac-FL-020, setting the stage for further clinical development. The goal is to establish 225Ac-FL-020 as a valuable treatment option for patients suffering from mCRPC.

"The clearance of our IND application marks a pivotal regulatory achievement in the development of 225Ac-FL-020," said Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life. "This milestone highlights our commitment to the potential of radiopharmaceuticals and underscores the dedication and collaborative efforts of our team. We are eager to initiate the Phase I clinical program, which will provide the first opportunity to gather essential human data on the safety and anti-tumor activity of 225Ac-FL-020."

225Ac-FL-020 is a next-generation PSMA-targeting radionuclide drug conjugate (RDC) that will be entering global Phase I clinical trials in 2024. The targeting vector FL-020 was discovered using Full-Life's proprietary UniRDC™ platform, which significantly enhances drug uptake in tumors while ensuring rapid systemic clearance. Preclinical models have shown that 225Ac-FL-020 is highly effective in combating tumors and has a favorable safety profile.

Full-Life Technologies is a global radiotherapeutics company with operations in Belgium, Germany, and China. The company is committed to owning the entire value chain for radiopharmaceutical research, development, production, and commercialization to make a clinical impact on patients. Full-Life addresses core challenges in radiopharmaceuticals through innovative research aimed at developing future treatments. The company comprises a team of dedicated entrepreneurs and scientists with extensive experience in life sciences, radioisotope research, and clinical development.