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news.Celldex Therapeutics has begun patient dosing in a Phase 1 study of its hematopoietic growth factor, CDX-301, in healthy subjects.
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CDX-301 is soluble, recombinant human FMS-like tyrosine kinase 3 ligand (Flt3L) that stimulates the expansion and differentiation of hematopoietic progenitor and stem cells.
The dose-escalating Phase 1 study of CDX-301 which is being studied in alliance with Rockefeller University will enroll around 30 healthy subjects to assess seven different dosing regimens of CDX-301.
The study will also determine the appropriate dose of CDX-301for further development based on safety, tolerability and biological activity.
Celldex Therapeutics chief medical officer Thomas Davis said they hope that CDX-301 has significant potential to be developed in a number of indications in cancer, inflammatory and infectious diseases.
Earlier trials have shown that CDX-301 increases the numbers and activity of blood stem cells and immune cells.
The company has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy (PTI) Platform.