FDA Approves Full-Life Technologies' IND Application for 225Ac-FL-020 in Treating Metastatic Castration-Resistant Prostate Cancer

Full-Life Technologies, an internationally integrated company specializing in radiotherapeutics, has announced that the U.S. Food and Drug Administration has approved its Investigational New Drug Application. This approval pertains to clinical trials for 225Ac-FL-020, a PSMA-targeted radiopharmaceutical designed for treating metastatic castration-resistant prostate cancer. The firm aims to initiate these clinical trials both within the United States and internationally in 2024.

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225Ac-FL-020 leverages targeted alpha-radiotherapy to selectively eliminate cancer cells while minimizing harm to healthy tissues. In preclinical settings, the radiolabeled FL-020 demonstrated an exceptional in vivo biodistribution pattern, characterized by high and sustained tumor uptake and rapid systemic elimination. 225Ac-FL-020 showed significant anti-tumor efficacy in LNCaP xenograft mouse models and exhibited a favorable safety profile.

The forthcoming Phase I clinical trial aims to assess the safety, tolerability, and anti-tumor efficacy of 225Ac-FL-020, laying the foundation for further clinical advancement. The goal is to establish 225Ac-FL-020 as a promising treatment option for patients with mCRPC.

“The IND application clearance represents a crucial regulatory achievement in our development strategy for 225Ac-FL-020," stated Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life. "This critical step showcases our commitment to exploring the therapeutic potential of radiopharmaceuticals and highlights the dedication, hard work, and cross-functional collaboration of our team. We are enthusiastic about commencing the Phase I clinical program, which will provide the first opportunity to collect human data on 225Ac-FL-020’s safety and anti-tumor activity.”

225Ac-FL-020 is an innovative, potentially best-in-class, next-generation PSMA-targeting radionuclide drug conjugate scheduled to enter global Phase I clinical trials in 2024. The targeting vector, FL-020, was identified using Full-Life’s proprietary UniRDC™ platform, which enhances drug uptake in tumors while ensuring rapid systemic clearance. 

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According to the data provided by the Synapse Database, As of June 6, 2024, there are 253 investigational drugs for the PSMA targets, including 246 indications, 304 R&D institutions involved, with related clinical trials reaching 4415, and as many as 26846 patents.

225Ac-FL-020 highlights its potential as a novel therapeutic option for metastatic castration-resistant prostate cancer. The drug's targeting of PSMA and its classification as a radionuclide drug conjugate position it as a promising candidate in the field of therapeutic radiopharmaceuticals. As the development of 225Ac-FL-020 progresses, it will be important to monitor its clinical advancements and potential impact on the treatment of prostate.