Celldex Therapeutics Presents Positive Preclinical Data from TSLP/SCF Bispecific Antibody Program CDX-622 at IMMUNOLOGY2023™
15 Mai 2023 - 2:01PM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced
preclinical data from CDX-622, the Company’s bispecific antibody
with dual targeting of the alarmin TSLP and stem cell factor (SCF),
also known as KIT receptor ligand, developed from its bispecific
antibody platform. TSLP and SCF have been shown to contribute to
the pathophysiology of various inflammatory, fibrotic and allergic
disorders. These data were presented in a poster session as part of
IMMUNOLOGY2023™, the annual meeting of the American Association of
Immunologists (AAI).
The preclinical data show CDX-622 potently neutralizes the
alarmin TSLP, a potent mediator of inflammation, and blocks SCF/KIT
interaction required for mast cell function and survival. CDX-622
was well tolerated and demonstrated a favorable pharmacokinetic
profile as well as robust evidence of skin mast cell depletion in
preclinical models. The biophysical and functional characteristics
of CDX-622 support the initiation of development activities
including manufacturing and IND-enabling studies.
“Clinical studies with our KIT antibody, barzolvolimab,
have demonstrated the significant potential of mast cell depletion
through the inhibition of KIT. CDX-622 builds on this understanding
and adds a second critical inflammatory pathway—TLSP mediated
inflammation,” said Tibor Keler, Ph.D., Executive Vice President
and Chief Scientific Officer of Celldex Therapeutics. “The data
presented at AAI demonstrate that we have successfully combined
blockade of these two complementary inflammatory pathways into one
molecule and support the further advancement of CDX-622, which we
believe provides a unique opportunity to target multiple pathways
in disease settings where using combination therapies is
challenging.”
In the preclinical data presented at IMMUNOLOGY 2023, CDX-622
demonstrated potent inhibition of TSLP and SCF with a similar
potency as comparator monoclonal antibodies in vitro. CDX-622 was
shown to have monoclonal antibody-like biophysical and
pharmacokinetic characteristics. The data also demonstrated strong
evidence of skin mast cell depletion, consistent with the expected
role of SCF/KIT in mast cell survival. Simultaneous inhibition of
TSLP and mast cells with CDX-622 may result in improved efficacy
over approaches targeting single pathways in inflammatory, fibrotic
and allergic disorders.
The poster presented at IMMUNOLOGY2023™ can be viewed on the
"Publications” page of the "Science" section of the Celldex
website.
About CDX-622CDX-622 is a bispecific antibody
developed from novel humanized antibodies specific for TSLP and
SCF. CDX-622 combines blockade of the alarmin TSLP with mast cell
inhibition through SCF neutralization. Combined blockade of these
non-redundant pathways that drive inflammation may lead to enhanced
clinical activity in certain inflammatory, fibrotic and allergic
disorders.
About Celldex’s Bispecific Antibody
PlatformCelldex’s deep antibody experience and in-house
manufacturing capabilities support efficient development of next
generation bispecific antibody programs for inflammatory/autoimmune
diseases and oncology. Bispecific antibodies can engage two
independent pathways involved in controlling immune reactions and
can overcome challenges associated with combination treatment
approaches. Targets are being selected based on new science as well
as their compatibility to be used in bispecific antibody formats
with Celldex’s existing antibody programs.
About Celldex Therapeutics, Inc.Celldex is a
clinical stage biotechnology company dedicated to developing
monoclonal and bispecific antibodies that address devastating
diseases for which available treatments are inadequate. Our
pipeline includes antibody-based therapeutics which have the
ability to engage the human immune system and/or directly affect
critical pathways to improve the lives of patients with
inflammatory diseases and many forms of cancer. 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 Company drug candidates, including
barzolvolimab (also referred to as CDX-0159), in current or future
indications; 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 effects of the outbreak of
COVID-19 on our business and results of operations; the
availability, cost, delivery and quality of clinical 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; 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; our ability to
continue to obtain 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; 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 ContactSarah CavanaughSenior Vice
President, Corporate Affairs & Administration(508)
864-8337scavanaugh@celldex.com
Patrick TillMeru Advisors(484)
788-8560ptill@meruadvisors.com
Celldex Therapeutics (NASDAQ:CLDX)
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