Celldex's Rindopepimut (Rintega(R)) Receives FDA Breakthrough Therapy Designation for the Treatment of Adult Patients with EG...
February 23 2015 - 8:01AM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that the
U.S. Food and Drug Administration (FDA) has granted rindopepimut
(Rintega®) Breakthrough Therapy Designation for the treatment of
adult patients with EGFRvIII-positive glioblastoma (GBM).
This application was based on data from the Phase 2 ReACT study
in recurrent GBM, the Phase 2 ACT III study in newly diagnosed GBM
and additional supportive Phase 2 studies. An international Phase 3
study of rindopepimut, called ACT IV, in newly diagnosed GBM
completed enrollment (n=745) in December of 2014.
"The FDA's decision to grant Breakthrough Designation
underscores rindopepimut's therapeutic potential for patients with
glioblastoma," said Anthony Marucci, Co-founder, President and
Chief Executive Officer of Celldex Therapeutics. "These patients
have extremely limited treatment options, with only three new drugs
approved in more than twenty years. Emerging clinical data suggests
that rindopepimut may offer an improvement over existing standard
of care for EGFRvIII-positive patients. With continued positive
data, we look forward to working closely with the FDA to support
potential approval of rindopepimut as expeditiously as
possible."
According to the FDA, Breakthrough Therapy Designation is
intended to expedite the development and review of drugs for
serious or life-threatening conditions. The criteria for
Breakthrough Therapy Designation require preliminary clinical
evidence that demonstrates the drug may have substantial
improvement on at least one clinically significant endpoint over
available therapy.
Rindopepimut (Rintega) is an investigational immunotherapy that
targets the tumor specific oncogene EGFRvIII. Patients with
EGFRvIII-positive glioblastoma typically have a worse prognosis
than the overall glioblastoma population, including poor long term
survival.
About Rindopepimut
Rindopepimut (Rintega®) is an investigational immunotherapy that
targets the tumor specific oncogene EGFRvIII (v3), a functional and
permanently activated variant of the epidermal growth factor
receptor (EGFR), a protein that has been well validated as a target
for cancer therapy. Expression of EGFRvIII correlates with
increased tumorigenicity in mouse models and poor long term
survival in clinical studies of patients with glioblastoma (GBM).
In addition, EGFRvIII-positive cells are believed to stimulate
proliferation of non-EGFRvIII cells through IL-6 cell-to-cell
signaling and to release microvesicles containing EGFRvIII, which
can merge with neighboring cells, transferring tumor-promoting
activity. EGFRvIII expression may also be associated with tumor
stem cells that have been identified in GBM. These stem cells
contribute to resistance to cytotoxic therapy and tumor recurrence.
EGFRvIII is expressed in tumors in about 30% of patients with GBM.
It has not been detected at a significant level in normal tissues;
therefore, targeting of this tumor-specific molecule is not likely
to impact healthy tissues.
Three Phase 2 trials of rindopepimut—ACTIVATE, ACT II, and ACT
III—have been completed in newly diagnosed EGFRvIII-positive GBM
and have shown consistent improvements in both overall survival and
median progression-free survival. The most common adverse events
for rindopepimut include injection site reactions, fatigue, rash,
nausea and pruritus. Rindopepimut is currently being studied in two
clinical trials in EGFRvIII-positive GBM—an international Phase 3
study called ACT IV in newly diagnosed GBM and a Phase 2 study
called ReACT in recurrent GBM.
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 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 future
development and commercialization (by Celldex and others) of
Rintega® ("rindopepimut"; "rindo"; CDX-110). 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; 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
Breakthrough Therapy Designation for rindopepimut, 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: Company Contact:
Sarah Cavanaugh
Vice President of Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Media Inquiries:
Dan Budwick
Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
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