Celldex Therapeutics Announces Initiation of Phase 1/2 Study of Varlilumab in Combination with Ipilimumab and CDX-1401 in Met...
April 06 2015 - 8:01AM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced the
initiation of a Phase 1/2 safety pilot and expansion study
examining the investigational combination of varlilumab and
ipilimumab (Yervoy®; Bristol-Myers Squibb) in patients with Stage
III or IV metastatic melanoma. Varlilumab is Celldex's fully human
monoclonal antibody that targets CD27, a critical co-stimulatory
molecule in the immune activation cascade. Ipilimumab, a
recombinant, human monoclonal antibody that blocks CTLA-4, is FDA
approved for the treatment of unresectable or metastatic melanoma.
In the Phase 2 portion of the study, patients with tumors that
express NY-ESO-1 will also receive CDX-1401, Celldex's
off-the-shelf antibody-based dendritic cell vaccine that targets
tumors expressing the NY-ESO-1 oncoprotein.
The three agents in this study were specifically selected
because they uniquely intervene at key points of immune regulation
and because Celldex has observed enhanced activity in preclinical
studies when varlilumab is combined with either checkpoint
inhibitors or with vaccines. In addition, this study will also
build on previous clinical data from the CDX-1401 experience that
suggests that CDX-1401 may predispose patients to better outcome on
checkpoint inhibitors, including ipilimumab. "We believe
sophisticated combination approaches centered on immunotherapy hold
significant promise for the treatment of cancer and, to this end,
are committed to exploring novel combinations across a broad array
of mechanisms and indications. This latest trial marks the third
Phase 1/2 combination study that varlilumab has entered and the
first three-drug combination study," said Thomas Davis, MD,
Executive Vice President and Chief Medical Officer of Celldex
Therapeutics.
The Phase 1 portion of the study will assess the safety and
tolerability of varlilumab at 0.3 and 3.0 mg/kg in combination with
ipilimumab at 3 mg/kg administered every three weeks to identify a
recommended dose for the Phase 2 portion of the study. The Phase 2
study will include two cohorts—one comprised of patients who are
NY-ESO-1 positive and one comprised of patients who are NY-ESO-1
negative. Patients who are NY-ESO-1 positive will also receive
CDX-1401 dosed at 1 mg (with poly-ICLC at 2 mg given as an
adjuvant) every three weeks in addition to varlilumab and
ipilimumab. In total, up to four doses of study treatment will be
administered. The primary objective for both cohorts is objective
response rate up to 24 weeks (ORR6) using standard, modified World
Health Organization response criteria. Secondary objectives for the
Phase 2 study include safety and tolerability, immunogenicity,
pharmacokinetics and further assessment of anti-tumor activity
across a broad range of endpoints. About
Varlilumab Varlilumab is a fully human monoclonal antibody
that targets CD27, a critical molecule in the activation pathway of
lymphocytes. CD27 can be effectively manipulated with activating
antibodies to induce potent anti-tumor responses and may result in
fewer toxicities due to its restricted expression and regulation.
Varlilumab is a potent anti-CD27 agonist that induces activation
and proliferation of human T cells when combined with T cell
receptor stimulation. In lymphoid malignancies that express CD27 at
high levels, varlilumab may have an additional mechanism of action
through a direct anti-tumor effect. Varlilumab has completed a
Phase 1 dose-escalation study, demonstrating potent immunologic
activity consistent with its mechanism of action and anti-tumor
activity in patients with advanced, refractory disease. No maximum
tolerated dose was reached and minimal toxicities were observed.
Celldex has initiated a broad development program for varlilumab to
explore its role as an immune activator in combination with a
number of complementary investigational and approved oncology
drugs. Varlilumab is currently being studied in three Phase 1/2
combination studies and several additional combination studies will
be initiated in 2015.
About CDX-1401
CDX-1401 is a next-generation, off-the-shelf cancer vaccine
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.
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.
Celldex Forward Looking Statement This 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 Rintega® ("rindopepimut"; "rindo"; CDX-110),
glembatumumab vedotin ("glemba"; CDX-011), varlilumab ("varli";
CDX-1127), CDX-1401, CDX-301 and other products and our goals for
2015. 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 Rintega, 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; 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 our 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: Celldex Company Contacts:
Investors:
Sarah Cavanaugh
Vice President of Investor Relations &
Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
or
Media:
Dan Budwick
Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
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