FDA Fast Tracks Full-Life's 225Ac-FL-020 for Metastatic Prostate Cancer

HEIDELBERG, Germany, July 2, 2024 – Full-Life Technologies (Full-Life), a radiotherapeutics firm with a global presence, has announced that the U.S. Food and Drug Administration (FDA) has given Fast Track Designation to 225Ac-FL-020, the company’s leading radiopharmaceutical. This drug targets prostate-specific membrane antigen (PSMA) and is intended for treating metastatic castration-resistant prostate cancer (mCRPC).

The FDA's Fast Track program is intended to expedite the development and review of drugs aimed at serious conditions with unmet medical needs. This recognition points to the potential effectiveness of 225Ac-FL-020 as a new treatment option for mCRPC, a disease that currently has few effective therapies.

Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life, commented on the designation, emphasizing its importance in addressing the urgent need for new mCRPC treatments. He noted that this will allow the company to work closely with the FDA, potentially speeding up the process of bringing 225Ac-FL-020 to patients.

225Ac-FL-020 is designed to deliver targeted alpha-radiotherapy, which selectively attacks cancer cells while minimizing harm to healthy tissues. Preclinical tests show that radiolabeled FL-020 has a promising biodistribution profile, including high and sustained tumor absorption and rapid systemic clearance. In LNCaP xenograft mice, 225Ac-FL-020 demonstrated significant anti-tumor activity and a favorable safety profile. The upcoming Phase I clinical trial will explore the safety, tolerability, and anti-tumor activity of the drug. In May 2024, the FDA cleared Full-Life’s Investigational New Drug (IND) Application for clinical trials of 225Ac-FL-020.

About 225Ac-FL-020
225Ac-FL-020 is a novel, next-generation PSMA-targeting radionuclide drug conjugate (RDC). It began global Phase I clinical studies in 2024. The targeting vector, FL-020, was discovered using Full-Life’s proprietary UniRDC™ platform, which enhances drug uptake in tumors while ensuring quick systemic clearance. In preclinical models, the drug has shown strong anti-tumor activity and a favorable safety profile.

About Full-Life Technologies
Full-Life Technologies is a comprehensive global radiotherapeutics company operating in Belgium, Germany, and China. The company aims to control the entire value chain from research and development to production and commercialization, aiming to deliver significant clinical benefits to patients. Full-Life focuses on overcoming basic challenges in radiopharmaceuticals through innovative research, seeking to shape future treatments. The company comprises a team of driven entrepreneurs and experienced scientists with a proven track record in life sciences and radioisotope research and clinical development.