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-020
225Ac-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 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 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