Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced initiation of
a Phase 1 study of its therapeutic human antibody candidate, CDX-1127,
in patients with selected malignant solid tumors or hematologic cancers.
CDX-1127 is a fully human monoclonal antibody that binds CD27, an
important co-stimulatory molecule on T cells. CDX-1127, an agonist
antibody designed to activate patients’ immune cells against their
cancer, has shown potent efficacy in several preclinical models. In
addition, CD27 is over-expressed in certain lymphomas and leukemias and
can be directly targeted by CDX-1127.
The Phase 1 study is designed to test 5 escalating doses of CDX-1127 to
determine a Phase 2 dose for further development based on safety,
tolerability, potential activity and immunogenicity. The study will
accrue approximately 30 patients in each of the two arms, either solid
tumors or lymphomas/leukemias. Patients will have received all
appropriate prior therapies for their specific disease. The trial design
incorporates both single dosing and multiple dosing regimens at each
dose level. The study, anticipated to complete accrual in approximately
1 year, is being conducted at multiple clinical sites in the United
States.
"The CDX-1127 program is our first therapeutic antibody and demonstrates
our development capabilities to rapidly and successfully translate
concept into clinical trials,” said Anthony S. Marucci, President and
Chief Executive Officer of Celldex Therapeutics. "We believe strongly in
the opportunities for immune modulating antibodies and the pre-clinical
data generated with CDX-1127 through our collaboration with University
of Southampton, UK has been very encouraging.”
About CDX-1127
CDX-1127 is a human monoclonal antibody program targeting CD27, a member
of the tumor necrosis factor (TNF) receptor superfamily. CD27 is a
critical molecule in the activation pathway of lymphocytes.
It acts downstream from CD40 and may provide a novel way to regulate the
immune responses. CD27 is a co-stimulatory molecule on T cells and is
over-expressed in certain lymphomas and leukemias. Previously published
data by Professor Martin Glennie, Ph.D., Director of Cancer Sciences,
Tenovus Research Laboratory, University of Southampton, UK, has
demonstrated that targeting CD27 with monoclonal antibodies in mice is
highly effective at promoting anti-cancer immunity. Celldex presented
more recent preclinical in vitro and animal data with CDX-1127 at
the 2011 American Association for Cancer Research (AACR) 101st
Annual Meeting demonstrating that targeting CD27 receptors with CDX-1127
can increase the numbers of responding T cells and can mediate
significant anti-tumor activity. CDX-1127 was also shown to directly
impact tumor cells expressing CD27. The solid tumor indications that can
enroll into the Phase 1 study include; refractory patients with
metastatic melanoma, renal (clear) cell carcinoma, hormone-refractory
prostate adenocarcinoma, ovarian and colorectal adenocarcinoma, and
non-small cell lung cancer.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination
immunotherapy company. Celldex 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. The PTI Platform is a complementary portfolio of
monoclonal antibodies, antibody-targeted vaccines and immunomodulators
used in optimal combinations 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 (by Celldex and others) of rindopepimut (CDX-110),
CDX-011, CDX-1135 (formerly TP10), CDX-1401, CDX-1127, CDX-301,
Belinostat and other products. 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, our ability to obtain additional capital
on acceptable terms, or at all, including the additional capital which
will be necessary to complete the clinical trials that we plan to
initiate in 2011; 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 limited experience in
bringing programs through Phase 3 clinical trials; our ability to manage
research and development efforts for multiple products at varying stages
of development; the timing, cost and uncertainty of obtaining regulatory
approvals; the failure of the market for the Company's programs to
continue to develop; our limited cash reserves and our ability to obtain
additional capital on acceptable terms, or at all; our ability 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, 2010,
and its Forms 10-Q and 8-K.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You are cautioned not to place undue
reliance on any forward-looking statements, which speak only as of the
date of this release. We have no obligation, and expressly disclaim any
obligation, to update, revise or correct any of the forward-looking
statements, whether as a result of new information, future events or
otherwise.
