Tee Labs Incubatee: Full-Life Technologies Announces FDA Approval of IND Application for New Drug ²²⁵Ac-FL-020

Tee Labs Incubatee: Full-Life Technologies Announces Clearance from FDA of IND Application for ²²⁵Ac-FL-020 for the Treatment of Metastatic Castration-Resistant Prostate Cancer.Heidelberg, Germany – May 30, 2024 – Full-Life Technologies (Full-Life), a fully integrated global radiotherapeutics company, today announced it has received clearance of its Investigational New Drug (IND) Application from the U.S. Food and Drug Administration (FDA) for clinical trials of ²²⁵Ac-FL-020, its PSMA-targeted radiopharmaceutical for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The company plans to begin clinical studies in the U.S. and globally in 2024.

²²⁵Ac-FL-020 employs targeted alpha-radiotherapy designed to selectively attack cancer cells, reducing the damage to healthy tissues. In preclinical models, radiolabeled FL-020 displayed a very promising in vivo biodistribution profile, with high and sustained tumor uptake and fast systemic clearance. ²²⁵Ac-FL-020 exhibited robust anti-tumor activity in LNCaP xenograft mice, with a favorable safety profile. The upcoming Phase I clinical trial will evaluate the safety, tolerability, and anti-tumor activity of ²²⁵Ac-FL-020, and will lay the groundwork for further clinical development, aiming to establish ²²⁵Ac-FL-020 as a valuable therapeutic option for patients with mCRPC.

“The IND application clearance is a significant regulatory milestone in our development plan for ²²⁵Ac-FL-020”, said Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life. “This important step underscores our overall commitment to the therapeutic potential of radiopharmaceuticals and once again highlights the value of the team´s effort, dedication, and cross-functional collaboration. We are excited to initiate the Phase I clinical program, which provides the first opportunity to gather human data on ²²⁵Ac-FL-020’s safety and anti-tumor activity.”

About ²²⁵Ac-FL-020

²²⁵Ac-FL-020 is a novel, potential best-in-class, next-generation PSMA-targeting radionuclide drug conjugate (RDC) that will enter global Ph1 clinical studies in 2024. Its targeting vector, FL-020, was discovered using Full-Life’s proprietary UniRDC™ platform, which enables significant improvement of drug uptake in the tumor while maintaining fast systemic clearance. In pre-clinical models, ²²⁵Ac-FL-020 has demonstrated potent anti-tumor activity and a favorable safety profile.

About Full-Life Technologies

Full-Life Technologies (“Full-Life”) is a fully integrated global radiotherapeutics company with operations in Belgium, Germany, and China. We aim to own the entire value chain for radiopharmaceutical research & development, production & commercialization in order to deliver clinical impact for patients. The Company plans to attack core issues affecting radiopharmaceuticals today through innovative research that targets the treatments of tomorrow. We are comprised of a team of fast-moving entrepreneurs and scientists with a demonstrated track record in the life sciences, as well as radioisotope research and clinical development.

About Tee Labs

Tee Labs is an international community and entrepreneurial incubator established in collaboration with entrepreneurs and venture capitalists, dedicated to assisting in the development of cutting-edge medical fields such as new drug research and development, diagnosis, and individual healthcare, including artificial intelligence and digital solutions. We provide comprehensive support including research and development facilities, enterprise functions, integration of supply and service channels, funding, etc., to deeply assist entrepreneurial teams and accelerate the speed of enterprise research and development. The laboratory is equipped with basic universal experimental equipment and a shared equipment platform, greatly shortening the preparation stage of start-up enterprises in the early stage of site and equipment, allowing enterprises to focus on core research and development work. At present, Tee Labs has approximately 2600 square meters of incubation space, including a 1500 square meter experimental area with secondary laboratories for chemistry, molecular biology, cell culture, bacterial culture, and BSL-2. Multiple types of experimental spaces can support enterprises with different research and development directions to carry out experimental work, and also provide early companies with the option of multifunctional teams working in the same space.