Celldex Therapeutics’ CDX‑1401, CDX‑301 Combination Generates Potent NY-ESO-1 Immune Responses in Patients with Melanom...
June 04 2016 - 2:02PM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today results
from a Phase 2 clinical study evaluating CDX‑1401 and CDX‑301 in
patients with malignant melanoma, which was conducted by the Cancer
Immunotherapy Trials Network (CITN) under a Cooperative Research
and Development Agreement (CRADA) between Celldex and the Cancer
Therapy Evaluation Program of the National Cancer Institute.
CDX‑1401 is an NY‑ESO‑1-antibody fusion protein for immunotherapy,
and CDX‑301 (recombinant human Flt3 ligand) is a potent
hematopoietic cytokine that uniquely expands dendritic cells and
hematopoietic stem cells. Results from the study were presented at
the 2016 American Society of Clinical Oncology (ASCO) Annual
Meeting in Chicago in a poster titled “A Phase 2, Open-label,
Multicenter, Randomized Study of CDX‑1401, a Dendritic Cell
Targeting NY‑ESO‑1 Vaccine, in Patients with Malignant Melanoma
Pre-Treated with CDX‑301, a Recombinant Human Flt3 Ligand.”
The study randomized 60 patients with resected stage IIb through
IV melanoma into two cohorts (n=30 each) to assess whether the
immune response to NY-ESO-1 elicited by CDX-1401 could be
substantially increased by pre-treatment with CDX-301 to expand the
number of dendritic cells, which are key cells in initiating immune
responses. As this study was intended primarily for safety and
immune endpoints, patients were not selected for NY‑ESO‑1
expression. Both treatment cohorts received four monthly cycles of
CDX‑1401 and poly-ICLC (Hiltonol®). Cohort 1 received pre-treatment
with CDX‑301 for the first two cycles, whereas Cohort 2 did not
receive CDX‑301. Both combination regimens were well tolerated, and
no drug-related adverse events required discontinuation from
treatment.
NY-ESO-1 specific T cell responses were significantly greater
and developed earlier in Cohort 1 compared to Cohort 2. In
addition, all patients in Cohort 1 (n=30) achieved a specific
NY-ESO-1-specific T cell response compared to 22 out of 30 patients
in Cohort 2. Substantial increases in innate immune cells
(dendritic cells, natural killer cells and monocytes) and greater
increases in antibody titer were observed in the CDX‑301
pre-treated Cohort 1.
“The Cancer Immunotherapy Trials Network has prioritized CDX-301
as a dendritic cell growth factor. The current study validates that
Flt3 ligand can greatly expand peripheral blood dendritic cells and
is highly effective at immunizing cancer antigen specific T cells
when combined with CDX-1401, the immunotherapy that delivers
NY‑ESO‑1 to dendritic cells,” said Martin “Mac” Cheever, M.D., a
member of the Vaccine and Infectious Disease Division at Fred
Hutchinson Cancer Research Center, Professor of Medicine at the
University of Washington and Director of the Fred Hutch-based
Cancer Immunotherapy Trials Network. “These results, which show
rapid cellular immune responses in a majority of patients, should
stimulate significant interest in what appears to be a highly
applicable, effective immunologic approach.”
“This study confirms that CDX-1401 is effective at driving
NY-ESO-1 immunity and further shows the value of CDX-301 as a
combination agent for enhancing tumor-specific immune responses,”
said Thomas Davis, M.D., Executive Vice President and Chief Medical
Officer of Celldex Therapeutics. “With these results, we are
initiating a targeted study in patients with NY‑ESO‑1 positive
disease to determine if these enhanced immune responses can
translate to improved clinical outcomes. This also provides
exciting new opportunities for use of CDX-301 in other combination
immunotherapy regimens.”
The poster is available on the "Publications" page of the
"Science" section of the Celldex website.
About CDX‑301CDX‑301 (Flt3L) is a potent
hematopoietic cytokine that has demonstrated a unique capacity to
increase the number of circulating dendritic cells in both
laboratory and clinical studies. In addition, CDX‑301 has shown
impressive results in models of cancer, infectious diseases and
inflammatory/autoimmune diseases. Celldex believes this ligand may
hold significant opportunity for synergistic development in
combination with other proprietary molecules in the Company's
portfolio.
About CDX‑1401CDX‑1401 is an NY‑ESO‑1-antibody
fusion protein for immunotherapy, which is designed to activate the
patient's immune system against cancers that express the tumor
marker, NY‑ESO‑1. CDX‑1401 consists of a fully human monoclonal
antibody with specificity for the dendritic cell receptor DEC‑205
genetically linked to the NY‑ESO‑1 tumor antigen. Celldex has
accessed NY‑ESO‑1 through a licensing agreement with the Ludwig
Institute for Cancer Research. By selectively delivering the
NY‑ESO‑1 antigen to dendritic cells in the body, CDX‑1401 is
intended to induce robust immune responses against the
antigen-expressing cancer cells.
Hiltonol is a registered trademark of Oncovir, Inc.
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.
Contact:
Sarah Cavanaugh
Vice President of Investor Relations & Corp Communications
(781) 433-3161
scavanaugh@celldex.com
Charles Liles
Manager of Investor Relations & Corp Communications
(781) 433-3107
cliles@celldex.com
Media Contact:
Dan Budwick
Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
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