Celldex Therapeutics Announces Clinical Trial Collaboration with Roche to Evaluate the Combination of Varlilumab and MPDL3280...
March 17 2015 - 8:01AM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that it
has entered into a clinical trial collaboration with Roche to
evaluate the safety, tolerability and preliminary efficacy of
varlilumab, Celldex's CD27 targeting investigational antibody, and
MPDL3280A (anti-PDL1), Roche's investigational cancer immunotherapy
in a Phase 1/2 study in renal cell carcinoma.
Varlilumab and MPDL3280A are part of a new class of
investigational medicines known as cancer immunotherapies that are
designed to harness the body's own immune system to fight cancer
through separate yet complementary mechanisms of action that may
enable the activation of T cells, restoring their ability to
effectively detect and attack tumor cells. Preclinical data suggest
the combination of these two mechanisms are synergistic and may
enhance anti-tumor immune response compared to either agent alone.
In Celldex's Phase 1 study of varlilumab in multiple solid tumors,
promising signs of clinical activity in patients with refractory
renal cell carcinoma were observed, including a durable partial
response (11.0+ months) that has continued to decrease in tumor
volume over time and prolonged stable disease (4 patients with a
range of 5.3 to 30.7+ months).
"This collaboration with Roche furthers our ongoing initiative
to investigate varlilumab's potential in combination with a broad
range of mechanisms and across multiple tumor types," said Thomas
Davis, MD, Executive Vice President and Chief Medical Officer of
Celldex Therapeutics. "Varlilumab is currently being studied in two
Phase 1/2 combination studies and we expect it will enter at least
another four combination studies this year. This latest trial is
supported by promising signs of single-agent activity observed in
our Phase 1 study in patients with renal cell carcinoma. We believe
combining an immune activator with a checkpoint inhibitor in this
disease setting may augment this activity and the synergy
demonstrated in our preclinical varlilumab/anti-PDL1 combination
models provide further support for this approach."
Under the terms of this agreement, Roche will provide study drug
and Celldex will be responsible for conducting and funding the
study, which is expected to begin in 2015.
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
two Phase 1/2 combination studies and several additional
combination studies will be initiated in 2015.
About MPDL3280A (anti-PDL1) MPDL3280A (also
known as anti-PDL1 and RG7446) is an investigational monoclonal
antibody designed to interfere with a protein called PD-L1.
MPDL3280A is designed to target PD-L1 expressed on tumor cells and
tumor-infiltrating immune cells, preventing it from binding to PD-1
and B7.1 on the surface of T cells. By inhibiting PD-L1, MPDL3280A
may enable the activation of T cells, restoring their ability to
effectively detect and attack tumor cells.
About Celldex 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 rindopepimut, 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
Investors & Company:
Sarah Cavanaugh, (508) 864-8337 or scavanaugh@celldex.com
Media:
Dan Budwick (973)-271-6085 or dan@purecommunicationsinc.com
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