Celldex Presents Data on New Product Candidate, CDX-1140, a Novel CD40 Agonist Antibody
November 14 2016 - 8:01AM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) presented data on new
product candidate CDX-1140, a fully human antibody targeted to CD40
that has demonstrated potent agonist activity. Found on antigen
presenting cells, such as dendritic cells, macrophages and B cells,
CD40 is a key activator of the immune response. The data were
presented at the Society for Immunotherapy of Cancer Annual Meeting
(SITC) on Saturday, November 12 in a poster titled “Functional
characterization of CDX-1140, a novel CD40 antibody agonist for
cancer immunotherapy.” CDX-1140 is expected to be ready to enter
clinical studies in 2017.
“The CD40 pathway plays a critical role in the activation of
innate and adaptive immune responses,” said Tibor Keler, Ph. D.,
Executive Vice President and Chief Scientific Officer of Celldex
Therapeutics. “We believe an ideal CD40 immunotherapy candidate
should have the right balance of agonist activity and safety
profile to allow systemic dosing at levels that provide good tissue
and tumor penetration. The data presented at SITC show that
CDX-1140 has a unique profile to meet this goal relative to other
CD40 agonist antibodies and will be an important addition to our
growing immunotherapy pipeline.”
The poster features detailed analyses of the preclinical data
and is available on the “Publications” page of the “Science”
section of the Celldex website. Key findings include:
- CDX-1140 binds CD40 with high affinity and specificity and does
not block CD40 ligand binding
- CDX-1140 has an unmodified IgG2 backbone and demonstrates
potent agonist activity independent of Fc receptor
interactions
- CDX-1140 demonstrates direct anti-tumor activity in
immune-deficient mice challenged with human lymphomas
- Pharmacological activity was observed in vivo with minimal
evidence of toxicity
Celldex is currently performing manufacturing and IND-enabling
studies to support Phase 1 dose-escalation studies. 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 is
built from a proprietary portfolio of antibodies and
immunomodulators used alone and in strategic combinations to create
novel, disease-specific therapies that induce, enhance or suppress
the body's immune response. 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,
including those related to the Company's strategic focus and the
future development and commercialization (by Celldex and others) of
glembatumumab vedotin ("glemba"; CDX-011), varlilumab ("varli";
CDX-1127) and other products and our goals for 2016.
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 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; 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 Cavanaugh
Vice President of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Charles Liles
Associate Director of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3107
cliles@celldex.com
Media Inquiries
Dan Budwick
BrewLife
(973) 271-6085
dbudwick@brewlife.com
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