--Data presented at iSBTc meeting; Phase 2 initiation in first quarter 2010--
NEEDHAM, Mass.--(Business Wire)--
Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced positive results from
Phase 1 studies of CDX-1307 in patients with advanced epithelial cancers,
including breast, colon, bladder and pancreatic cancer. CDX-1307, the first
candidate from the Company`s Precision Targeted Immunotherapy Platform, utilizes
monoclonal antibodies to deliver vaccine directly to the patient`s immune system
and focuses the immune system against hCG beta (hCG-β), a cancer-associated
target believed to play a role in more aggressive forms of the disease. The
data, presented at the 24th Annual Meeting of the International Society for
Biological Therapy of Cancer (iSBTc) in Washington, D.C., demonstrated enhanced
immunological and biological responses and support the planned initiation of
Phase 2 clinical trials in hCG-β expressing cancers.
The Phase 1 studies investigated the safety and immunogenicity of CDX-1307 alone
and in combination with adjuvants, including GM-CSF and Toll-like Receptor (TLR)
agonists (poly-ICLC or Hiltonol and R848 or resiquimod). The studies enrolled
more than 80 patients with heavily pretreated, advanced-stage breast, colon,
bladder and pancreatic cancer, with an average of 4.6 prior therapies across the
treatment population. All patient cohorts demonstrated a favorable safety
profile with no dose limiting toxicity to date. The combination of CDX-1307 with
TLR agonists significantly enhanced immune responses against hCG-β, providing
strong humoral responses in 88% of patients and cellular immune responses in 57%
of patients analyzed to date. Immune responses occurred even in the presence of
high circulating levels of hCG-β, suggesting that the CDX-1307 can overcome
antigen tolerance in advanced and heavily pretreated cancers. Nine patients in
the studies experienced disease stabilization from 2.3 months to 11.4 months
following the initiation of CDX-1307 vaccination. Two of these patients have
received multiple courses of CDX-1307 and continue treatment with stable disease
at 6.4 and 11.4 months. These data provide the basis for advancing CDX-1307 into
a front-line patient population selected for hCG-βexpressing cancers. Celldex is
planning the initiation of a Phase 2 study in patients with newly diagnosed
bladder cancer in the first quarter of 2010.
"We have developed a CDX-1307 combination regimen that has shown promising
results eliciting immunogenic and biologic responses in patients with advanced,
difficult to treat and heavily pretreated cancers," said Thomas Davis, M.D.,
Senior Vice President and Chief Medical Officer of Celldex Therapeutics. "Based
on these findings, we will focus our efforts on CDX-1307 in earlier stage
cancers where hCG-β appears to play an important role and where immunotherapy is
likely to be even more effective, beginning with the initiation of a Phase 2
study in early-stage bladder cancer. Bladder cancer frequently expresses hCG-β
and represents a clear unmet medical need-which we believe provides an excellent
opportunity for CDX-1307."
About CDX-1307
CDX-1307 is in early-stage development for the treatment of epithelial cancers
that express the beta chain of human chorionic gonadotropin, known as hCG-β.
hCG-β is a tumor associated antigen that is often linked to more aggressive
disease and poor patient outcome. CDX-1307 is a fusion protein composed of a
mannose receptor-specific human monoclonal antibody genetically fused with the
hCG-β antigen. This antibody-vaccine is designed to deliver hCG-β directly to
the patient`s immune system via the antibody which attaches to dendritic cells
and induce strong hCG-β specific immune responses. This antibody delivery
approach contrasts with earlier generation vaccines that required dendritic
cells to find and ingest 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 CDX-1307 and our other programs.
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 CuraGen and Celldex; 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.
Anthony S. Marucci, 781-433-0771
President and CEO
or
Celldex Therapeutics, Inc.
Avery W. Catlin, 781-433-0771
Chief Financial Officer
IR@celldextherapeutics.com
or
For Media:
BMC Communications Group
Matthew Driscoll, 212-477-9007 x20
mdriscoll@bmccommunications.com
Copyright Business Wire 2009
