Precirix Receives FDA Clearance to Begin Phase 1 Trial of CAM-FAP-Ac-225 Targeted Alpha Therapy
Key Insights
The FDA has accepted Precirix's IND application for CAM-FAP-Ac-225 (search), a novel targeted alpha therapy combining a FAP (search)-targeting antibody with Actinium-225 (search) for treating solid tumors (search).
CAM-FAP-Ac-225 (search) targets fibroblast activation protein (search) (FAP (search)), which is highly expressed in cancer (search)-associated fibroblasts across a broad range of epithelial tumors (search).
The clearance enables Precirix to initiate a Phase 1 clinical trial evaluating safety, tolerability, dosimetry, and preliminary efficacy in patients with FAP (search)-positive advanced solid tumors (search).
Precirix, a clinical-stage biopharmaceutical company focused on developing innovative targeted radiopharmaceutical therapies, announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for CAM-FAP-Ac-225 (search). This regulatory clearance enables the company to initiate a Phase 1 clinical trial in patients with FAP (search)-positive tumors.
Novel Targeted Alpha Therapy Approach
CAM-FAP-Ac-225 (search) represents a best-in-class radiopharmaceutical that combines a fibroblast activation protein (search) (FAP (search))-targeting single domain antibody vector with the potent alpha-emitting isotope Actinium-225 (search). The therapy is designed to deliver targeted radiation directly to the tumor microenvironment via a FAP-targeting ligand.
FAP (search) is highly expressed in cancer (search)-associated fibroblasts (CAFs) across a broad range of epithelial tumors (search), making it a promising target for broad therapeutic application. The alpha particles emitted by Actinium-225 (search) exhibit high linear energy transfer (LET), enabling potent and localized cytotoxicity with minimal off-target effects.
Clinical Development Plans
Following FDA clearance, Precirix plans to initiate a Phase 1 clinical trial to evaluate the safety, tolerability, dosimetry, and preliminary efficacy of CAM-FAP-Ac-225 (search) in patients with advanced solid tumors (search) known to express FAP (search).
"The FDA's acceptance of the IND for our CAM-FAP-Ac-225 (search) 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."
Company Background
Precirix is a private biopharmaceutical company dedicated to extending and improving the lives of cancer (search) patients by designing and developing precision radiopharmaceuticals, using camelid single domain antibodies (sdAb) labeled with a variety of radioisotopes. The company's focus on targeted radiopharmaceutical therapies positions it at the forefront of precision oncology approaches.