A lead radiopharmaceutical of the company, 225Ac-FL-020 acts on prostate-specific membrane antigen (PSMA).
The fast track programme of the FDA aims to expedite the development and regulatory review of innovative treatments for serious ailments with unmet medical needs.
mCRPC is a condition with limited effective treatments.
225Ac-FL-020 uses alpha-radiotherapy to specifically attack cancer cells, minimising damage to healthy tissues.
In preclinical models, radiolabelled FL-020 showed a promising in vivo biodistribution profile, with high and sustained tumour uptake and rapid systemic clearance.
225Ac-FL-020 demonstrated strong anti-tumour activity in LNCaP xenograft mice and had a favourable safety profile.
In May this year, Full-Life obtained clearance for an investigational new drug (IND) application from the FDA to commence clinical trials of 225Ac-FL-020.
A Phase I clinical trial is set to assess the asset’s safety, tolerability, and anti-tumour activity of 225Ac-FL-020.
The company intends to commence clinical trial of the product in the US and across the globe this year.
Full-Life chief medical officer Steffen Heeger said: “The FDA fast track designation for 225Ac-FL-020 underscores the critical need for innovative and effective treatments for mCRPC.
“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.”
In January this year, the company secured a financing of $63.3m, which comprised $47.3m raised in a Series B funding round and $16m through loan facilities.
The investment is aimed at progressing the development of its radiopharmaceutical pipeline, manufacturing expertise and streamlining its UniRDC discovery platform.