Full-Life Technologies Announces U.S. FDA IND Clearance and Australian Regulatory Clearance for [²²⁵Ac]Ac-FL-261 Phase 1 Clinical Trial

LONDON, Sept. 9, 2026 /PRNewswire/ -- Full-Life Technologies ("Full-Life", the "Company"), a privately held, fully integrated, clinical-stage actinium-based global radiopharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug ("IND") application for [²²⁵Ac]Ac-FL-261 and that the program has received Australian Human Research Ethics Committee ("HREC") approval and completed the Clinical Trial Notification ("CTN") process with Therapeutic Goods Administration ("TGA"). 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 ("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. "[²²⁵Ac]Ac-FL-261 is designed to selectively target c-MET-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."

The planned first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of [²²⁵Ac]Ac-FL-261 in patients with nsNSCLC. Full-Life plans to conduct clinical development in the United States, Australia and other key regions.

About [²²⁵Ac]Ac-FL-261

[²²⁵Ac]Ac-FL-261 is Full-Life's potential first-in-class c-MET-targeted alpha radioconjugate for multiple solid tumor indications. It is designed to selectively bind c-MET-expressing tumors and deliver alpha-particle radiation directly to tumor cells. FL-261 is one of the various radiopharmaceutical assets developed utilizing Full-Life's proprietary UniRDC™ discovery platform.

About UniRDC™

UniRDC™ is Full-Life's proprietary discovery platform which allows for rapid generation of radiopharmaceutical development candidates with optimized therapeutic properties. By integrating proprietary synthetic chemistry and protein-engineering capabilities, UniRDC™ enables high and sustained tumor uptake in humans while avoiding key safety organs, addressing two long-standing challenges in radiopharmaceutical chemistry. 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.

About Full-Life Technologies

Full-Life Technologies ("Full-Life") is a privately held, fully integrated, clinical-stage actinium-based global radiopharmaceutical company focused on developing next-generation targeted radioconjugate for patients. Full-Life has three clinical-stage programs: [²²⁵Ac]Ac-FL-020, a PSMA-targeted alpha radioconjugate currently being evaluated in a global Phase 1 trial for metastatic castration-resistant prostate cancer (mCRPC); [²²⁵Ac]Ac-FL-261, a potentially first-in-class c-MET-targeted alpha radioconjugate being developed for multiple solid tumor indications, with an initial focus on non-squamous non-small cell lung cancer (nsNSCLC); and an NTSR1-targeted small-molecule radioconjugate currently being evaluated in a Phase 1 clinical trial under a collaboration with a strategic partner. The Company has fully integrated capabilities spanning drug discovery, clinical development, Actinium-225 production, and manufacturing, and has completed the construction of a state-of-the-art GMP-compliant Ac-225 manufacturing and radiolabeling facility in Belgium. 

SOURCE Full-Life Technologies