Full-Life Technologies Announces FDA IND Clearance for ²²⁵Ac-FL-020, a Next-Generation PSMA-Targeted Radiopharmaceutical for Metastatic Castration-Resistant Prostate Cancer

May 30, 2024, Heidelberg, GermanyFull-Life Technologies Limited (hereinafter referred to as “Full-Life Technologies”), a fully integrated international radiopharmaceutical therapy company, announced today that its PSMA-targeted radiopharmaceutical ²²⁵Ac-FL-020 has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This marks a significant step forward in Full-Life Technologies’ initiation of clinical trials in the United States and globally in 2024.

²²⁵Ac-FL-020 employs targeted alpha therapy to precisely target cancer cells, thereby reducing 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 LNCaP xenograft mouse models, ²²⁵Ac-FL-020 exhibited superior antitumor activity and an excellent safety profile. An upcoming Phase I clinical trial will comprehensively evaluate the safety and tolerability of ²²⁵Ac-FL-020 and further investigate its antitumor efficacy. This will lay the foundation for further clinical development, holding promise for providing more effective treatment options for patients with metastatic castration-resistant prostate cancer (mCRPC).

Dr. Steffen Heeger, Chief Medical Officer at Full-Life Technologies, stated, “The approval of the IND application marks a significant regulatory milestone in the development program for ²²⁵Ac-FL-020. This critical progress fully reflects our firm commitment to the therapeutic potential of radiopharmaceuticals, while also demonstrating the relentless efforts and collaborative spirit of our team. We look forward to initiating the Phase I clinical trial as soon as possible, which will provide us with the first human data on the safety and anti-tumor activity of ²²⁵Ac-FL-020.”

²²⁵Ac-FL-020 is an innovative, potential best-in-class next-generation PSMA-targeted radionuclide drug conjugate (RDC) under development by Full-Life Technologies. This therapeutic candidate is designed for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and is scheduled to enter 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 has demonstrated promising antitumor efficacy and a favorable safety profile.

Full-Life Technologies Co., Ltd. (“Full-Life Technologies”) is a fully integrated, international radiopharmaceutical therapeutics company with offices in Belgium, Germany, and China. Committed to building a nuclear medicine enterprise encompassing the entire value chain of radiopharmaceutical R&D, manufacturing, and commercialization, Full-Life Technologies aims to benefit patients worldwide. The company plans to address core challenges currently impacting radiopharmaceutical development through innovative research focused on future therapeutic approaches. The Full-Life Technologies team comprises seasoned entrepreneurs and scientists who excel not only in managing biopharmaceutical companies but also possess deep expertise in the research and clinical development of radioisotopes.

Full-Life Technologies

Email: pr@t-full.com

Website:www.full-life.com