Precirix, a clinical-stage biopharmaceutical company and a spin-off of Vrije Universiteit Brussel (VUB), has announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for CAM-FAP-Ac-225. This significant achievement paves the way for Precirix to begin a Phase 1 clinical trial for patients battling FAP-positive tumors.
CAM-FAP-Ac-225 is an innovative radiopharmaceutical that combines a fibroblast activation protein (FAP)-targeting single domain antibody vector with the potent alpha-emitting isotope Actinium-225. FAP is a highly expressed protein in cancer-associated fibroblasts (CAFs) across a wide range of epithelial tumors, making it a promising target for broad therapeutic application in oncology. CAM-FAP-Ac-225 delivers Actinium-225 directly to the tumor microenvironment via a FAP-targeting ligand. The alpha particles emitted by Actinium-225 are known for their high linear energy transfer (LET), which enables potent and localized cytotoxicity with minimal off-target effects.
"The FDA’s acceptance of the IND for our CAM-FAP-Ac-225 targeted radiotherapy program marks an extraordinary milestone for Precirix and is a testament to the dedication and scientific excellence of our entire team," said Tom Plitz, Chief Executive Officer of Precirix. "The clearance to start our Phase 1 study represents not only the beginning of clinical development for a potentially transformative therapy, but also a major step forward in our mission to deliver precision treatment options to patients with high unmet medical needs. We are incredibly proud of this achievement and energized by the path ahead."
Precirix, a spin-off of VUB’s Molecular Imaging (MIMA) research group and the UZ Brussel Nuclear Medicine Department, is dedicated to extending and improving the lives of cancer patients by designing and developing precision radiopharmaceuticals using camelid single domain antibodies (sdAb) labeled with various radioisotopes. This latest FDA acceptance underscores Precirix's commitment to advancing innovative and precise cancer treatments.