Full-Life Technologies Announces FDA Fast Track Designation for ²²⁵Ac-FL-020 in Metastatic Castration-Resistant Prostate Cancer

Heidelberg, Germany, July 3, 2024 – Full-Life Technologies (hereinafter referred to as “Full-Life Technologies”), a fully integrated international radiopharmaceutical therapy company, today announced its flagship radiopharmaceutical²²⁵Ac-FL-020 has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). This drug targets prostate-specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

The Fast Track program is dedicated to accelerating the development and regulatory approval of potential innovative therapies, promoting breakthrough treatments for serious diseases, and addressing urgent unmet medical needs. This designation highlights²²⁵The Innovative Potential of Ac-FL-020 in the Treatment of mCRPC. In the current medical landscape, effective therapeutic options for mCRPC remain limited, making this advancement particularly significant.

Dr. Steffen Heeger, Chief Medical Officer of Full-Life Technologies, stated: “The FDA granted²²⁵The Fast Track designation for Ac-FL-020 reflects the urgent need for innovative and effective therapies among patients with metastatic castration-resistant prostate cancer (mCRPC). This designation will enable us to collaborate more closely with the FDA throughout the drug development process, thereby potentially accelerating²²⁵"The launch of Ac-FL-020 enables patients to benefit at an earlier stage."

²²⁵Ac-FL-020 employs targeted alpha therapy to precisely target cancer cells, thereby minimizing damage to healthy tissues. In preclinical models, radiolabeled FL-020 demonstrated excellent in vivo distribution characteristics, including high and sustained tumor uptake as well as rapid systemic clearance, in the LNCaP xenograft mouse model.²²⁵Ac-FL-020 demonstrates superior antitumor activity and an excellent safety profile. A Phase I clinical trial has been initiated to evaluate²²⁵To comprehensively evaluate the safety and tolerability of Ac-FL-020 and to thoroughly investigate its antitumor activity. Prior to this,²²⁵Ac-FL-020 received FDA approval for its Investigational New Drug (IND) application in May 2024.

²²⁵Ac-FL-020 is an innovative, potential best-in-class next-generation PSMA-targeted radionuclide drug conjugate (RDC) under development by Full-Life Technologies. Designed for the treatment of metastatic castration-resistant prostate cancer (mCRPC), the drug entered global Phase I clinical trials in 2024. Its targeting vector, FL-020, was developed using Full-Life Technologies’ proprietary UniRDC™ platform, a technology that significantly enhances drug uptake at tumor sites while ensuring rapid systemic clearance. In preclinical models,²²⁵Ac-FL-020 demonstrated promising antitumor efficacy and a favorable safety profile.

Full-Life Technologies (“Full-Life”) is a fully integrated, international radiopharmaceutical therapy company with offices in Belgium, Germany, and China. Patient-centric on a global scale, Full-Life is committed to building a comprehensive nuclear medicine enterprise that integrates the research and development, manufacturing, and commercialization of radiopharmaceuticals. By leveraging leading innovative research to address the fundamental challenges currently facing the field of radiopharmaceuticals, Full-Life aims to advance the development of future therapies. The Full-Life team comprises a highly efficient entrepreneurial leadership group and seasoned scientists with extensive proven success in life sciences, radioisotope research, and clinical development.