FDA Clears Full-Life Tech's 225Ac-FL-020 for Treating Metastatic Castration-Resistant Prostate Cancer

Full-Life Technologies, an all-encompassing international radiotherapeutics firm, has recently revealed that the U.S. Food and Drug Administration has approved its Investigational New Drug Application. This approval pertains to the clinical trials of 225Ac-FL-020, a radiopharmaceutical aimed at PSMA for the treatment of metastatic castration-resistant prostate cancer. The company intends to commence clinical trials both in the United States and internationally in 2024.

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225Ac-FL-020 utilizes targeted alpha-radiotherapy to selectively destroy cancerous cells, thereby minimizing harm to normal tissues. In preclinical studies, radiolabeled FL-020 showed exceptional in vivo biodistribution, characterized by significant and prolonged accumulation in tumors and rapid clearance from the body. 

In LNCaP xenograft mice, 225Ac-FL-020 demonstrated strong anti-tumor effects with an acceptable safety profile. The forthcoming Phase I clinical trial will assess 225Ac-FL-020’s safety, tolerability, and anti-cancer efficacy, establishing a foundation for subsequent clinical studies and potentially positioning 225Ac-FL-020 as a key treatment for patients with mCRPC.

“The clearance of the IND application signifies a crucial regulatory achievement in our developmental trajectory for 225Ac-FL-020,” remarked Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life. “This milestone emphasizes our dedication to the therapeutic promise of radiopharmaceuticals and the diligence and interdisciplinary cooperation of our team. We eagerly anticipate the initiation of the Phase I clinical program, which will provide our first human data on the safety and anti-tumor potential of 225Ac-FL-020.”

225Ac-FL-020 represents a promising, next-generation PSMA-targeting radionuclide drug conjugate set to commence global Phase I clinical trials in 2024. The FL-020 targeting vector was discovered through Full-Life’s exclusive UniRDC™ platform, significantly enhancing drug uptake in tumors while ensuring rapid systemic elimination. Preclinical models have shown that 225Ac-FL-020 possesses strong anti-tumor properties and a favorable safety profile.

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According to the data provided by the Synapse Database, As of June 3, 2024, there are 251 investigational drugs for the PSMA targets, including 243 indications, 298 R&D institutions involved, with related clinical trials reaching 4417, and as many as 26777 patents.

225Ac-FL-020 holds promise as a targeted therapeutic option for a challenging and life-threatening condition, and its advancement through the development process will be of interest to stakeholders in the pharmaceutical and healthcare industries.