HEIDELBERG, Germany, July 2, 2024 /PRNewswire/ -- Full-Life Technologies (Full-Life), a fully integrated global radiotherapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for 225Ac-FL-020, the company's lead radiopharmaceutical, which targets prostate-specific membrane antigen (PSMA), for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
The Fast Track program is designed to facilitate the development and regulatory review of novel potential therapies intended to treat serious conditions and fill an unmet need. This designation highlights the potential of 225Ac-FL-020 to provide a novel therapeutic option for patients with mCRPC, a condition for which there are currently limited effective treatments.
"The FDA Fast Track Designation for 225Ac-FL-020 underscores the critical need for innovative and effective treatments for mCRPC", said Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life. "This designation will enable us to collaborate more closely with the FDA throughout the development process, potentially accelerating the availability of 225Ac-FL-020 to patients."
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 Phase I clinical trial will evaluate the safety, tolerability, and anti-tumor activity of 225Ac-FL-020. In May 2024, Full-Life received clearance of its Investigational New Drug (IND) Application from the FDA for clinical trials of 225Ac-FL-020.
About 225Ac-FL-020225Ac-FL-020 is a novel, potential best-in-class, next-generation PSMA-targeting radionuclide drug conjugate (RDC) that entered 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 TechnologiesFull-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 to deliver clinical impact for patients. The Company endeavors to tackle fundamental challenges affecting radiopharmaceuticals today by pioneering innovative research that will shape the treatments of tomorrow. We are comprised of a team of fast-moving entrepreneurs and seasoned scientists with a proven history of success in the life sciences, alongside radioisotope research and clinical development.
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The Fast Track program is designed to facilitate the development and regulatory review of novel potential therapies intended to treat serious conditions and fill an unmet need. This designation highlights the potential of 225Ac-FL-020 to provide a novel therapeutic option for patients with mCRPC, a condition for which there are currently limited effective treatments.
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"The FDA Fast Track Designation for 225Ac-FL-020 underscores the critical need for innovative and effective treatments for mCRPC", said Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life. "This designation will enable us to collaborate more closely with the FDA throughout the development process, potentially accelerating the availability of 225Ac-FL-020 to patients."
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 Phase I clinical trial will evaluate the safety, tolerability, and anti-tumor activity of 225Ac-FL-020. In May 2024, Full-Life received clearance of its Investigational New Drug (IND) Application from the FDA for clinical trials of 225Ac-FL-020.
About 225Ac-FL-020225Ac-FL-020 is a novel, potential best-in-class, next-generation PSMA-targeting radionuclide drug conjugate (RDC) that entered 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 TechnologiesFull-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 to deliver clinical impact for patients. The Company endeavors to tackle fundamental challenges affecting radiopharmaceuticals today by pioneering innovative research that will shape the treatments of tomorrow. We are comprised of a team of fast-moving entrepreneurs and seasoned scientists with a proven history of success in the life sciences, alongside radioisotope research and clinical development.
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SOURCE Full-Life Technologies
