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Roth Capital upgrades CLDX

Roth Capital Upgrades Celldex Therapeutics to Buy
By Juan Lopez
Benzinga Staff Writer
January 17, 2012 7:31 AM

It took a while for the Market to take notice, but now the SP is up 27%

CLDX also announced this morning that it had initiated a clinical trial with CDX 301


Celldex Therapeutics Announces Initiation of Phase 1 Clinical Trial of CDX-301
Business WirePress Release: Celldex Therapeutics, Inc. – 4 hours ago



Celldex Therapeutics, Inc.

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CLDX 3.56 +0.41

NEEDHAM, Mass.--(BUSINESS WIRE)-- Celldex Therapeutics, Inc. (Nasdaq: CLDX - News) today announced that dosing has initiated in a Phase 1 study of its hematopoietic growth factor, CDX-301, in healthy subjects. The study is being conducted in collaboration with Rockefeller University. 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.”

About CDX-301 (Flt3L)

CDX-301 or Flt3L is a potent hematopoietic cytokine that stimulates the expansion and differentiation of hematopoietic progenitor and stem cells. Flt3L has demonstrated a unique capacity to increase the number of circulating dendritic cells in both laboratory and clinical studies. In addition, Flt3L has shown impressive results in models of cancer, infectious diseases and inflammatory/autoimmune diseases. Celldex believes this ligand may hold significant opportunity for synergistic development in combination with other proprietary molecules in the Company’s portfolio.


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