Drug intelligence / Profile preview

89Zr-DFO-REGN5054

Development stage
Phase 1
Lead developer
Regeneron Pharmaceuticals
Modality
Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Positron Emitters → Radiopharmaceuticals, Gamma Emitters → Radiopharmaceuticals, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

**89Zr-DFO-REGN5054 is a fully human monoclonal antibody radiolabeled with zirconium‑89 for use as a diagnostic radiopharmaceutical in immuno-PET imaging.** It specifically binds to the CD8α antigen on human and cynomolgus T cells, enabling noninvasive detection and quantification of CD8+ T cells (including tumor-infiltrating lymphocytes) in vivo. The antibody is conjugated to the chelator desferrioxamine (DFO) for stable attachment of zirconium‑89, allowing PET imaging to monitor immune responses during cancer immunotherapy. Preclinical studies have shown specific targeting of lymphoid tissues and minimal impact on T-cell activity, supporting its use as an imaging biomarker for assessing immune cell dynamics in patients undergoing cancer treatment. Developed by Regeneron Pharmaceuticals, it is being investigated primarily for neoplasms/solid tumors[1][2][3][5][7].

Other names
REGN5054REGN-5054REGN 5054
02

Targets

CD8A (T-cell surface glycoprotein CD8 alpha chain)CD8A (CD8 alpha/beta Coreceptor)

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