#United States #London #Radiopharmaceutical #Full-Life Technologies #c-MET targeted therapy

Full-Life Technologies Secures FDA and Australian Clearance for [²²⁵Ac]Ac-FL-261

In a significant advancement for targeted cancer therapy, Full-Life Technologies has announced that its clinical trial application for the novel radiopharmaceutical [²²⁵Ac]Ac-FL-261 has received clearance from the U.S. Food and Drug Administration (FDA). Additionally, the company has attained ethical approval from the Human Research Ethics Committee (HREC) in Australia and completed the Clinical Trial Notification (CTN) process with the Therapeutic Goods Administration (TGA). This paves the way for a Phase 1 clinical trial evaluating [²²⁵Ac]Ac-FL-261 in patients suffering from c-MET-expressing non-squamous non-small cell lung cancer (nsNSCLC).

Dr. Debora Barton, Chief Medical Officer of Full-Life Technologies, expressed the significance of these approvals, stating, "These regulatory clearances represent a vital milestone for FL-261 and our strategy to expand targeted alpha therapy into various solid tumors." This underscores the potential of the product to deliver potent alpha radiation directly to tumor sites, potentially changing how certain cancers are treated.

Overview of [²²⁵Ac]Ac-FL-261

[²²⁵Ac]Ac-FL-261 represents Full-Life's first-in-class approach specifically designed to target c-MET-expressing tumors, providing a unique mechanism to combat cancer. By using alpha radiation, the therapy is intended to attack cancer cells directly, while minimizing damage to surrounding healthy tissue. The ongoing clinical studies aim not only to determine safety and tolerability but also to explore preliminary antitumor activity, which could inform future cancer treatment strategies.

The Phase 1 study will assess the pharmacokinetics of [²²⁵Ac]Ac-FL-261, helping researchers gain insights into how the drug behaves in human bodies. Full-Life Technologies plans for this clinical development to extend beyond the U.S. and Australia, encompassing key regions globally, indicating the potential for widespread application of this promising therapy.

UniRDC™: A Foundation for Innovation

At the heart of Full-Life's developments is their proprietary discovery platform, UniRDC™. This innovative platform allows for rapid development of potential radiopharmaceuticals, enabling the team to optimize therapeutic properties efficiently. By integrating advanced synthetic chemistry with protein-engineering expertise, UniRDC™ facilitates significant tumor uptake in patients while shielding critical safety organs against radiation exposure. This addresses historic challenges within the realm of radiopharmaceutical chemistry and significantly eases the journey from concept to clinical candidate, with a projected timeline of under two years.

Since its inception, the UniRDC™ platform has generated multiple assets that are currently in the clinical stage, validating its effectiveness and allowing Full-Life Technologies to solidify partnerships with leading pharmaceutical entities.

About Full-Life Technologies

Full-Life Technologies is a clinical-stage, fully integrated actinium-based radiopharmaceutical company committed to the development of next-generation targeted therapies. The company’s pipeline includes multiple clinical assets—such as [²²⁵Ac]Ac-FL-020, aimed at treating metastatic castration-resistant prostate cancer, and ongoing collaborations that enhance its research capabilities. With a state-of-the-art manufacturing facility compliant with Good Manufacturing Practices (GMP) established in Belgium, Full-Life is positioned to lead the future of oncology treatments using cutting-edge radiotherapeutics.

As Full-Life Technologies advances through this pivotal phase of development, stakeholders and the medical community at large eagerly anticipate the outcomes of the forthcoming trials that may reshape cancer treatment paradigms.