Celldex Therapeutics Initiates Phase 1 Study of New Bispecific Product Candidate CDX-527 in Solid Tumors
August 24 2020 - 8:01AM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that
enrollment has opened in its open-label, Phase 1 study of CDX-527
in patients with advanced or metastatic solid tumors that have
progressed during or after standard of care therapy. CDX-527 is the
first candidate from Celldex’s bispecific antibody platform. It
uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human
antibodies to couple CD27 costimulation with blockade of the
PD-L1/PD-1 pathway to help prime and activate anti-tumor T cell
responses through CD27 costimulation, while preventing PD-1
inhibitory signals that subvert the immune response.
"CDX-527 builds on our prior clinical experience where the
combination of CD27 activation and PD-1 blockade was well tolerated
and demonstrated biological and clinical activity when the
individual agents were dosed together,” said Tibor Keler, Ph.D.,
Executive Vice President and Chief Scientific Officer of Celldex
Therapeutics. “We believe this bodes well for the potential safety
and activity profile of CDX-527, which incorporates the two
mechanisms into one molecule. Importantly, preclinical studies of
CDX-527 also demonstrated greater activity than the combination of
individual antibodies, adding to our enthusiasm that this
next-generation checkpoint inhibitor could be an important addition
to the Celldex pipeline.”
This study, which is expected to enroll up to approximately 90
patients with solid tumors, is designed to determine the maximum
tolerated dose, or MTD, during a dose-escalation phase and to
recommend a dose level for further study in a subsequent expansion
phase. The expansion phase is designed to further evaluate the
tolerability and biologic effects of selected dose level(s) of
CDX-527 in specific tumor types. Secondary objectives of the study
include analyses of safety and tolerability, 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: NCT04440943).
About CDX-527CDX-527 is a bispecific antibody
composed of Celldex’s proprietary PD-L1 and CD27 human antibodies.
CDX-527 combines blockade of the PD-1 pathway with T cell
costimulation through CD27 into one molecule using an IgG1-ScFv
format. Preclinical data demonstrate CDX-527 is more potent than
the combination of anti-PD-L1 and anti-CD27 antibodies in T cell
activation and anti-tumor activity. CDX-527 has direct
antibody-dependent cellular cytotoxicity (ADCC) against CD27 or
PD-L1 expressing tumor cells. In addition, CDX-527 exhibits an
antibody-like pharmacokinetic profile without concerning toxicity
in preclinical models. Prior clinical data with Celldex’s CD27
antibody as monotherapy and in combination with PD-1 inhibitors
supports combining these pathways in patients with cancer. The
Company believes that the potential for CDX-527 will include both
monotherapy and 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 immunotherapies and other targeted biologics 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
https://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
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expectations regarding future performance or events. Although
management believes that the expectations reflected in such
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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 Company drug candidates; the effects of the
outbreak of COVID-19 on our business and results of operations; our
ability to realize the cost benefits of consolidating our office
and laboratory space and to retain key personnel after that
consolidation; 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
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competition; changes in the regulatory landscape or the imposition
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will be necessary to complete the clinical trials that we have
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as of the date of this release. We have no obligation, and
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Company ContactSarah CavanaughSenior Vice
President, Corporate Affairs & AdministrationCelldex
Therapeutics, Inc.(781) 433-3161scavanaugh@celldex.com
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