CDX-301 is soluble, recombinant human FMS-like tyrosine kinase 3 ligand (Flt3L) and previous experience has shown that it increases the numbers and activity of blood stem cells and immune cells.
CDX-301 is a potent stem cell mobilizer and dendritic cell growth factor. While there are multiple possible indications for CDX-301, Celldex's first priority is to develop this molecule for hematopoietic stem cell transplant, where it has demonstrated improvement of blood cell reconstitution in preclinical in vivo models.
The Phase 1 study of CDX-301 is a dose-escalating clinical trial aimed at determining the appropriate dose for further development based on safety, tolerability and biological activity. The trial will evaluate seven different dosing regimens of CDX-301 and will accrue approximately 30 healthy subjects at Rockefeller University.
"This clinical trial represents the first step in the continued clinical development of this biologically active molecule," said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "In particular, we believe that CDX-301 has significant potential to be developed in a number of indications in cancer, inflammatory and infectious diseases."