FDA Clears IND for Full-Life's Actinium-225 c-MET Radioconjugate [225Ac]Ac-FL-261 in Non-Squamous NSCLC
核心洞察
Full-Life Technologies (搜索) received FDA IND clearance for [225Ac]Ac-FL-261 (搜索), a first-in-class c-MET (搜索)-targeted alpha radioconjugate, enabling a Phase 1 trial in the United States.
The program also secured Australian HREC approval and completed the TGA Clinical Trial Notification process, allowing parallel clinical development in Australia.
The first-in-human Phase 1 study will assess safety, tolerability, pharmacokinetics and preliminary antitumor activity in patients with c-MET (搜索)-expressing non-squamous non-small cell lung cancer (搜索).
Full-Life Technologies (搜索) announced that the U.S. Food and Drug Administration (搜索) has cleared its Investigational New Drug application for [225Ac]Ac-FL-261 (搜索), a potential first-in-class c-MET (搜索)-targeted alpha radioconjugate. The company simultaneously reported that the program received Australian Human Research Ethics Committee approval and completed the Clinical Trial Notification process with the Therapeutic Goods Administration (搜索). Together, these clearances enable Full-Life to advance a Phase 1 clinical trial of [225Ac]Ac-FL-261 in the United States and Australia in patients with c-MET-expressing non-squamous non-small cell lung cancer (搜索) (nsNSCLC).
"These regulatory clearances represent an important milestone for FL-261 and our strategy to expand targeted alpha therapy into various solid tumors," said Debora Barton, MD, Chief Medical Officer of Full-Life Technologies (搜索). "[225Ac]Ac-FL-261 (搜索) is designed to selectively target c-MET (搜索)-expressing tumors by delivering potent alpha radiation directly into the tumor sites. We look forward to advancing FL-261 into its Phase 1 trial and generating key clinical evidence that will help translate our preclinical findings and inform the continued development of this promising program."
Phase 1 Design and Development Plans
The planned first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of [225Ac]Ac-FL-261 (搜索) in patients with nsNSCLC. Full-Life stated that it plans to conduct clinical development in the United States, Australia and other key regions.
Targeting c-MET With Alpha-Particle Radiation
[225Ac]Ac-FL-261 (搜索) is described by the company as a potential first-in-class c-MET (搜索)-targeted alpha radioconjugate for multiple solid tumor indications. The agent is designed to selectively bind c-MET-expressing tumors and deliver alpha-particle radiation directly to tumor cells. FL-261 is one of several radiopharmaceutical assets developed using Full-Life's proprietary UniRDC discovery platform.
The UniRDC Discovery Platform
According to the company, UniRDC allows for rapid generation of radiopharmaceutical development candidates with optimized therapeutic properties. By integrating proprietary synthetic chemistry and protein-engineering capabilities, the platform is designed to enable high and sustained tumor uptake in humans while avoiding key safety organs — addressing two long-standing challenges in radiopharmaceutical chemistry. Full-Life states that the platform supports an accelerated path from target selection to a development candidate with human biodistribution data in less than 24 months. UniRDC has been dosed in over 100 patients, generated three clinical-stage assets to date and been validated by multiple partnerships with strategic pharmaceutical partners.
A Three-Program Actinium-225 Pipeline
Full-Life is a privately held, fully integrated, clinical-stage actinium-based global radiopharmaceutical company focused on developing next-generation targeted radioconjugates. The company has three clinical-stage programs: [225Ac]Ac-FL-020 (搜索), a PSMA (搜索)-targeted alpha radioconjugate currently being evaluated in a global Phase 1 trial for metastatic castration-resistant prostate cancer (搜索) (mCRPC); [225Ac]Ac-FL-261 (搜索), the c-MET (搜索)-targeted alpha radioconjugate now cleared for Phase 1 development in nsNSCLC; and an NTSR1 (搜索)-targeted small-molecule radioconjugate currently being evaluated in a Phase 1 clinical trial under a collaboration with a strategic partner.
The company reports fully integrated capabilities spanning drug discovery, clinical development, Actinium-225 production and manufacturing, and has completed construction of a GMP-compliant Ac-225 manufacturing and radiolabeling facility in Belgium.