Full-Life Technologies Reports Encouraging Preliminary Phase 1 Safety and PSA Decline for FL-020 in mCRPC at ESMO 2026

• Data updates from the ongoing Phase 1 dose-escalation study demonstrated promising therapeutic index in patients with mCRPC
• No dose-limiting toxicities observed; xerostomia has been predominantly Grade 1, with no cases of Grade 3
• 100% of lutetium-177-naive patients achieved PSA50, 88.9% achieved PSA80 and 66.7% achieved PSA90 at dose levels 6 to 8 MBq
• 75% of lutetium-177-exposed patients achieved PSA50, 62.5% achieved PSA80 and 25% achieved PSA90 at dose levels 6 to 8 MBq
• One complete response was observed by PSMA-PET imaging after two cycles of treatment with [²²⁵Ac]Ac-FL-020 in a patient whose best response to prior lutetium-177 therapy was progressive disease
• The data highlight the potential of [²²⁵Ac]Ac-FL-020 for patients with mCRPC, including those who have progressed on prior lutetium-177 PSMA-targeted therapy

LONDON, Oct. 23, 2026 /PRNewswire/ -- Full-Life Technologies ("Full-Life", the "Company"), a privately held, fully integrated, clinical-stage global radiopharmaceutical company, today announced encouraging preliminary data from its ongoing Phase 1 dose-escalation study of [²²⁵Ac]Ac-FL-020, an investigational prostate-specific membrane antigen ("PSMA")-targeted alpha radiopharmaceutical, in patients with metastatic castration-resistant prostate cancer ("mCRPC"). The data are being presented as an E-Poster at the European Society for Medical Oncology ("ESMO") Congress 2026 in Madrid, Spain.

At the October 9, 2026, data cut-off date, 18 patients had received [²²⁵Ac]Ac-FL-020 at 6, 7 and 8 megabecquerel ("MBq") and 17 were evaluable for prostate-specific antigen ("PSA") response. PSA decline was observed in both lutetium-177-naive and lutetium-177-exposed patients, and safety to date has supported dose escalation through 10 MBq. A Phase 2 dose optimization study is planned, in which patients will be randomized to two dosing regimens of [²²⁵Ac]Ac-FL-020, consistent with recent U.S. Food and Drug Administration ("FDA") draft guidance on dose optimization for radiopharmaceuticals.

"We believe [²²⁵Ac]Ac-FL-020 has the potential to address an important unmet need in patients with advanced prostate cancer, particularly those whose disease has progressed following lutetium-177 PSMA-targeted therapy", said Debora Barton, MD, Chief Medical Officer of Full-Life Technologies. "We are encouraged by the PSMA-PET complete response observed after two cycles of FL-020 at 7 MBq in a patient whose best response to prior lutetium-177 therapy was progressive disease. As the study progresses, our focus will be on defining the optimal dose and schedule, assessing the durability of response and further characterizing the benefit-risk profile of FL-020 for both lutetium-177-exposed and lutetium-177-naive patients."

Ongoing Phase 1 [²²⁵Ac]Ac-FL-020 ESMO data presentation

Poster title: ProTACT: A first-in-human, Phase 1 study evaluating the safety, tolerability, and anti-tumor activity of [²²⁵Ac]Ac-FL-020, a PSMA-targeted radioconjugate in patients with mCRPC – Dose escalation results

Poster number: 2323eP

Abstract number: 3396

Date: October 23 to 27, 2026

Data included dose levels of 6, 7 and 8 MBq. PSA50, PSA80 and PSA90 represent maximum PSA declines of at least 50%, 80% and 90% from baseline, respectively.

Efficacy

Safety and tolerability

• The safety population included 39 patients.
• No dose-limiting toxicities or deaths considered related to study drug have been observed.
• Three treatment-related serious adverse events (anemia, nausea and thrombocytopenia) were reported.
• No serious treatment-related renal or hepatobiliary adverse events have been reported.
• Xerostomia has been predominantly Grade 1.

"In this dose-escalation study, FL-020 produced PSA50 of 100% at dose levels 6 to 8 MBq in lutetium-177 PSMA-targeted therapy naive patients, alongside a safety profile that has supported completion of dose escalation," said Aaron R. Hansen, MBBS, FRACP, Professor of Medical Oncology, Princess Alexandra Hospital, Brisbane, Australia. "These results reinforce our confidence in FL-020's potential to become an important treatment option for patients with mCRPC and support its continued development to address unmet needs across the treatment landscape."

The ongoing Phase 1, open-label, dose-escalation study is evaluating the safety, tolerability, pharmacokinetics, dosimetry and preliminary antitumor activity of [²²⁵Ac]Ac-FL-020 in patients with mCRPC. These preliminary findings may change with additional follow-up and are not intended for direct cross-trial comparisons. [²²⁵Ac]Ac-FL-020 is investigational and has not been approved by any regulatory authority.

About [²²⁵Ac]Ac-FL-020

[²²⁵Ac]Ac-FL-020 is a next-generation investigational PSMA-targeted alpha radioconjugate. Discovered using Full-Life's proprietary UniRDC™ platform, FL-020 comprises a PSMA-targeting peptide labeled with actinium-225. The compound is designed to achieve high and sustained tumor uptake while maintaining rapid clearance from normal tissue, with the goal of providing improved efficacy and a differentiated safety profile. The U.S. FDA has granted [²²⁵Ac]Ac-FL-020 Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer.

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 radioconjugates 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. 

Media Contacts:
Full-Life
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Website: www.full-life.com

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SOURCE Full-Life Technologies