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June 24, 2025

Precirix Submits Investigational New Drug (IND) Application to FDA forCAM-FAP-Ac-225, a Novel Radiopharmaceutical Targeting Fibroblast Activation Protein (FAP)

Brussels, Belgium, 24th June 2025 — Precirix, a clinical-stage biotechnology company focused on developing targeted radiopharmaceutical therapies, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CAM-FAP-Ac-225, a novel targeted alpha therapy (TAT) designed to treat FAP-expressing solid tumors.


CAM-FAP-Ac-225 is a best-in-class radiopharmaceutical that combines a fibroblast activation protein (FAP)-targeting single domain antibody targeting vector, with the potent alpha-emitting isotope Actinium-225. FAP is highly expressed in cancerassociated fibroblasts (CAFs) across a broad range of epithelial tumors, making it a promising target for broad therapeutic application.


This IND submission marks a major milestone for Precirix and our mission to develop innovative and highly targeted cancer therapiessaid Tom Piltz, Chief Executive Officer of Precirix. “We are excited to advance CAM-FAP-Ac-225 into clinical development and believe that it has potential to set a new standard for FAP-directed radiopharmaceuticals”.

Following FDA clearance, the company plans to initiate a Phase 1 clinical trial to evaluate the safety, tolerability, dosimetry, and preliminary efficacy of CAM-FAP-Ac225 in patients with advanced solid tumors known to express FAP.

About CAM-FAP-Ac-225
CAM-FAP-Ac-225 is an investigational targeted alpha therapy that delivers Actinium225 directly to the tumor microenvironment via a FAP-targeting ligand. The alpha particles emitted by Ac-225 have high linear energy transfer (LET), enabling potent and localized cytotoxicity with minimal off-target effects.

About Precirix
Precirix is a private biopharmaceutical company dedicated to extending and improving the lives
of cancer patients by designing and developing precision radiopharmaceuticals, using camelid
single domain antibodies (sdAb) labelled with a variety of radioisotopes.


Contact:
Precirix NV
Tom Plitz, CEO
tom.plitz@precirix.com
info@precirix.com
http://www.precirix.com

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