Celldex Therapeutics Announces CDX-1307 Clinical Data at 45th Annual ASCO Meeting

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Mon Jun 1, 2009 11:01am EDT

- Novel vaccine strategy targeting dendritic cells in combination with TLR
agonists shows favorable safety profile and strong immune responses in Phase 1
study - 
ORLANDO, Fla.--(Business Wire)--
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that promising
clinical data from two Phase 1 studies of CDX-1307 were presented at the 45th
Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando,
Florida. CDX-1307 is a dendritic cell targeted immunotherapy designed to
stimulate an immune response against hCG Beta (hCG-β), a target antigen
frequently expressed in epithelial tumors. 

The comprehensive Phase 1 studies include over 70 patients and were designed to
investigate the safety and immunogenicity of CDX-1307 using different routes of
administration and in combination with immunostimulants, including GM-CSF and
toll-like receptor agonists (poly-ICLC/Hiltonol or R848/resiquimod). CDX-1307
was well tolerated with no dose limiting toxicity to date. Robust immune
responses were generated, and 7 patients with breast, colorectal and pancreatic
cancers experienced disease stabilization for 2.2+ to 6.5+ months. 

"We have made good progress with this innovative approach that combines multiple
agents from both our proprietary immunotherapy platform and recently in-licensed
assets," said Anthony Marucci, President and Chief Executive Officer at Celldex
Therapeutics. "We intend to enter CDX-1307 into Phase 2 clinical trials in the
second half of 2009." 

CDX-1307 is in early-stage development for the treatment of colorectal,
pancreatic, bladder, ovarian and breast cancers that express the beta chain of
human chorionic gonadotropin (hCG-β), an antigen often found in these tumors but
not in most normal tissues. CDX-1307 is a fusion protein composed of the hCG-β
antigen attached to a human monoclonal antibody that specifically targets the
mannose receptors on dendritic cells. This antibody-vaccine is designed to
deliver the antigen hCG-β directly to dendritic cells, activating the patient`s
immune system against cancers that express hCG-β. This targeted approach
contrasts with earlier generation vaccines that required dendritic cells to find
and ingest passive vaccines. 

About Celldex Therapeutics, Inc.

Celldex Therapeutics is an integrated biopharmaceutical company that applies its
comprehensive Precision Targeted Immunotherapy Platform to generate a pipeline
of candidates to treat cancer and other difficult-to-treat diseases. Celldex's
immunotherapy platform includes a complementary portfolio of monoclonal
antibodies, antibody-targeted vaccines and immunomodulators to create novel
disease-specific drug candidates. For more information, please visit
http://www.celldextherapeutics.com. 

Safe Harbor Statement Under the Private Securities Litigation Reform Act of
1995:This release contains ``forward-looking statements'' made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of 1995,
including those related to the Company's strategic focus and the future
development and commercialization of the Company`s CDX-1307 vaccine program.
Forward-looking statements reflect management's current knowledge, assumptions,
judgment and expectations regarding future performance or events. Although
management believes that the expectations reflected in such statements are
reasonable, they give no assurance that such expectations will prove to be
correct and you should be aware that actual results could differ materially from
those contained in the forward-looking statements. Forward-looking statements
are subject to a number of risks and uncertainties, including, but not limited
to, the successful integration of the businesses, multiple technologies and
programs of the two companies (Celldex and AVANT) that merged together in 2008
to form our Company; our ability to adapt APC Targeting TechnologyTM to develop
new, safe and effective vaccines against oncology and infectious disease
indications; our ability to successfully complete product research and further
development of our programs; the uncertainties inherent in clinical testing; our
ability to manage research and development efforts for multiple products at
varying stages of development; Pfizer`s and our strategy and business plans
concerning the continued development and commercialization of CDX-110; the
timing, cost and uncertainty of obtaining regulatory approvals; the failure of
the market for the Company's programs to continue to develop; the inability to
obtain additional capital; the inability to protect the Company's intellectual
property; the loss of any executive officers or key personnel or consultants;
competition; changes in the regulatory landscape or the imposition of
regulations that affect the Company's products; and other risks detailed from
time to time in the Company's filings with the Securities and Exchange
Commission, including the Company's Form 10-K for the fiscal year ended December
31, 2008, and its Forms 10-Q and 8-K.



Celldex Therapeutics, Inc.
Thomas Davis, +1-908-454-7120
Chief Medical Officer
or
BMC Communications Group
Dan Budwick, +1-973-271-6085
dbudwick@bmccommunications.com

Copyright Business Wire 2009

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