Celldex Therapeutics Initiates Phase 1 Study of New Product Candidate CDX-1140 in Solid Tumors
November 30 2017 - 8:01AM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that
enrollment has opened in its open-label, Phase 1 study of CDX-1140
in patients with advanced solid tumors. CDX-1140 is a fully human
antibody targeted to CD40, a key activator of immune response that
is found on dendritic cells, macrophages and B cells and is also
expressed on many cancer cells.
"CD40 has long been an important target for immunotherapy, as it
plays a critical role in the activation of innate and adaptive
immune responses; however, balancing systemic dosing and safety has
proven elusive to date for CD40 targeted activating therapeutics.
CDX-1140 is a unique, potent CD40 agonist that we believe has the
potential to successfully balance systemic doses for good tissue
and tumor penetration with an acceptable safety profile,” said
Tibor Keler, Ph.D., Executive Vice President and Chief Scientific
Officer of Celldex Therapeutics. “We look forward to characterizing
CDX-1140 in this Phase 1 study and rapidly moving into combination
studies with other anti-tumor agents.”
Study OverviewThis study, which is expected to
enroll up to approximately 105 patients with recurrent, locally
advanced or metastatic cancers, is designed to determine the
maximum tolerated dose during a dose-escalation phase and to
recommend dose(s) for further study in a subsequent expansion
phase. During the dose-escalation phase, patients will receive
CDX-1140 at dose levels ranging from 0.01 mg/kg to 3.0 mg/kg once
every four weeks until disease progression or intolerance. The
expansion phase is designed to further evaluate the tolerability
and biologic effects of selected dose(s) of CDX-1140 in specific
tumor types. Secondary objectives of the study include analyses of
safety and tolerability, pharmacodynamics, pharmacokinetics,
immunogenicity and assessment of anti-tumor activity across a broad
range of endpoints, such as objective response rate, clinical
benefit rate, duration of response, progression-free survival and
overall survival. More information about this study is available on
www.clinicaltrials.gov (Identifier: NCT03329950).
About CDX-1140CDX-1140 is a fully human
antibody targeted to CD40, a key activator of immune response that
is found on dendritic cells, macrophages and B cells and is also
expressed on many cancer cells. Potent CD40 agonist antibodies have
shown encouraging results in early clinical studies; however,
systemic toxicity associated with broad CD40 activation has limited
their dosing. CDX-1140 has unique properties relative to other CD40
agonist antibodies: potent agonist activity is independent of Fc
receptor interaction, contributing to more consistent, controlled
immune activation; CD40L binding is not blocked, leading to
potential synergistic effects of agonist activity near activated T
cells in lymph nodes and tumors; and the antibody does not promote
cytokine production in whole blood assays. CDX-1140 has shown
direct anti-tumor activity in preclinical models of lymphoma. The
Company believes that the potential for CDX-1140 will be best
defined in combination studies with other immunotherapies or
conventional cancer treatments.
About Celldex Therapeutics, Inc.Celldex is
developing targeted therapeutics to address devastating diseases
for which available treatments are inadequate. Our pipeline
includes antibodies, antibody-drug conjugates and other
protein-based therapeutics derived from a broad set of
complementary technologies which have the ability to engage the
human immune system and/or directly inhibit tumors to treat
specific types of cancer or other diseases. Visit
www.celldex.com.
Forward Looking StatementThis release contains
"forward-looking statements" made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
These statements are typically preceded by words such as
"believes," "expects," "anticipates," "intends," "will," "may,"
"should," or similar expressions. These 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 or that those goals will be
achieved, 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
successfully complete research and further development and
commercialization of glembatumumab vedotin and other Company drug
candidates; our ability to obtain additional capital to meet our
long-term liquidity needs on acceptable terms, or at all, including
the additional capital which will be necessary to complete the
clinical trials that we have initiated or plan to initiate; our
ability to realize the anticipated benefits from the acquisition of
Kolltan and to operate the combined business efficiently; the
uncertainties inherent in clinical testing and accruing patients
for clinical trials; our limited experience in bringing programs
through Phase 3 clinical trials; our ability to manage and
successfully complete multiple clinical trials and the research and
development efforts for our multiple products at varying stages of
development; the availability, cost, delivery and quality of
clinical and commercial grade materials produced by our own
manufacturing facility or supplied by contract manufacturers, who
may be our sole source of supply; the timing, cost and uncertainty
of obtaining regulatory approvals; our ability to maintain and
derive benefit from the Fast Track designation for glembatumumab
vedotin which does not change the standards for regulatory approval
or guarantee regulatory approval on an expedited basis, or at all;
the failure of the market for the Company's programs to continue to
develop; 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 factors listed under "Risk Factors" in our annual report
on Form 10-K and quarterly reports on Form 10-Q.
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.
Company Contact
Sarah CavanaughSenior Vice President, Corporate Affairs &
AdministrationCelldex Therapeutics, Inc.(781)
433-3161scavanaugh@celldex.com
Charles LilesAssociate Director, Investor Relations & Corp
CommunicationsCelldex Therapeutics, Inc.(617)
383-3433cliles@celldex.com
Dan BudwickFounder, 1AB Media(973) 271-6085dan@1abmedia.com
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