Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced three poster
presentations at the American Association for Cancer Research
(AACR) Annual Meeting 2016 in New Orleans. The Company previously
reported on four poster presentations at AACR, which included
Phase 1 safety and immune response data from the ongoing study
evaluating varlilumab and nivolumab in patients with advanced
cancers. New presentations included data enhancing the
understanding of glembatumumab vedotin’s mechanism of action and
further validation of the overexpression of its target, gpNMB, in a
wide range of tumor types. Additionally, the Company also presented
research with lead agonist antibodies targeting the CD40 receptor,
a promising target for immunotherapy, in a poster titled
“Development and characterization of novel CD40 antibody agonists
for cancer immunotherapy.”
Found on antigen presenting cells, such as dendritic cells,
macrophages and B cells, CD40 is a key activator of immune
responses. The Company has characterized two fully human antibodies
that demonstrated potent agonist activity, such as activating human
dendritic cells and B cells and indirectly inducing T cell
proliferation. Importantly, Fc receptor interaction, which could
cause signal amplification and is required for some CD40 agonist
antibodies in development, was not required for agonist ability,
enabling controlled, sensitive activation of CD40. Additionally,
the drug candidates were shown to upregulate CD95/Fas, a receptor
involved in apoptosis, on B cell lymphoma cell lines and to mediate
potent anti-tumor activity against the lymphomas in vivo.
“The CD40 pathway has a unique and powerful role in bridging the
innate and adaptive immune response, and if properly modulated, it
could become a very important part of cancer immunotherapy. We have
identified some promising and differentiated antibodies, from which
we will select a lead clinical candidate to complement our growing
immunotherapy pipeline,” said Tibor Keler, Ph.D., Executive Vice
President and Chief Scientific Officer of Celldex Therapeutics. “In
addition, we are enthusiastic about new research demonstrating
gpNMB overexpression in a broad set of tumor types, further
reinforcing the wide potential clinical applicability of
glembatumumab vedotin.”
The CD40 poster is available on the "Publications" page of the
"Science" section of the Celldex website.
Celldex and its collaborating investigators also presented two
additional posters supporting the clinical development of
glembatumumab vedotin:
Title: Glycoprotein NMB (gpNMB) overexpression is
prevalent in human cancers: pancreatic cancer, non-small cell lung
cancer, head and neck cancer, and osteosarcoma
gpNMB is the target of Celldex’s antibody-drug conjugate
glembatumumab vedotin. Using a validated immunohistochemistry (IHC)
assay to detect the expression of gpNMB, the Company examined
tissues from multiple types of solid tumors and normal tissue.
Overexpression of gpNMB in samples of tumor tissue versus normal
tissue was found in squamous cell carcinoma of the lung (85%),
osteosarcoma (62%), pancreatic cancer (55%), lung adenocarcinoma
(45%) and squamous cell carcinoma of the head and neck (40%). These
results support the potential broad applicability of gpNMB as a
therapeutic target across a wide range of tumor types. Celldex is
currently investigating glembatumumab vedotin in the pivotal METRIC
study in triple-negative breast cancer and in a Phase 2 study in
metastatic melanoma. Independent investigators are also studying
glembatumumab vedotin in uveal melanoma and osteosarcoma. A Phase
1/2 study in squamous cell carcinoma of the lung is expected to
commence in the second quarter of 2016.
The poster is available on the "Publications" page of the
"Science" section of the Celldex website.
Title: Targeting gpNMB with 89Zr-CR011 for PET imaging
of triple negative breast cancerAbstract:
4209
Collaborating investigators used a radio-labeled form of the
glembatumumab antibody to study uptake by tumor cells in vitro and
in vivo. Using positron emission tomography (PET) imaging with
xenograft models of triple-negative breast cancer (TNBC), the
investigators detected specific localization of glembatumumab in
the tumor and plan to perform similar studies with patient derived
tumor samples. These studies contribute to understanding the
mechanisms of action for glembatumumab vedotin, Celldex’s
antibody-drug conjugate targeting gpNMB, and may provide a
diagnostic approach for selecting patients with the greatest
likelihood of clinical benefit.
About Glembatumumab VedotinGlembatumumab
vedotin is a fully-human monoclonal antibody-drug conjugate (ADC)
that targets glycoprotein NMB (gpNMB). gpNMB is a protein
overexpressed by multiple tumor types, including breast cancer,
melanoma, lung cancer, uveal melanoma and osteosarcoma. gpNMB has
been shown to be associated with the ability of the cancer cell to
invade and metastasize and to correlate with reduced time to
progression and survival in breast cancer. The gpNMB-targeting
antibody, CR011, is linked to a potent cytotoxic, monomethyl
auristatin E (MMAE), using Seattle Genetics' proprietary
technology. Glembatumumab vedotin is designed to be stable in the
bloodstream but to release MMAE upon internalization into
gpNMB-expressing tumor cells, resulting in a targeted cell-killing
effect. Glembatumumab vedotin is in development for the treatment
of locally advanced or metastatic breast cancer with an initial
focus in triple negative disease, stage III and IV melanoma, uveal
melanoma and osteosarcoma.
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) 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 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.
Contact:Sarah CavanaughVice President of
Investor Relations & Corp Communications(781)
433-3161scavanaugh@celldex.com
Charles LilesManager of Investor Relations & Corp
Communications(781) 433-3107cliles@celldex.com
Media Contact: Dan BudwickPure Communications, Inc.(973)
271-6085dan@purecommunicationsinc.com
Celldex Therapeutics (NASDAQ:CLDX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Celldex Therapeutics (NASDAQ:CLDX)
Historical Stock Chart
From Apr 2023 to Apr 2024