May 23, 2012 04:01 PM Eastern Daylight Time NEEDHAM, Mass.--(BUSINESS WIRE)--Celldex
Therapeutics, Inc. (NASDAQ: CLDX) today announced preliminary results from the
Company’s randomized Phase 2b EMERGE study of CDX-011 (glembatumumab vedotin)
antibody drug conjugate in patients with glycoprotein NMB (GPNMB) expressing,
advanced, heavily pretreated breast cancer. Preliminary results suggest that
CDX-011 induces impressive response rates compared to current, available
therapies in patients with advanced, refractory breast cancers with high GPNMB
expression (expression in ≥25% of tumor cells). In this high expressing patient
population, treatment with CDX-011 resulted in a 32% overall response rate
(ORR; includes confirmed and unconfirmed responses), whereas treatment with
Investigator’s Choice (IC) single-agent chemotherapy resulted in a 13% ORR.
CDX-011 also demonstrated strong response rates in patients with triple
negative breast cancer across all levels of GPNMB expression (CDX-011 ORR of
21%; IC ORR of 0%), where treatment options are extremely limited. In addition,
in patients with triple negative breast cancer who also highly express GPNMB,
greater activity was observed (CDX-011 ORR of 36%; IC ORR of 0%). The ORR
across all levels of GPNMB expression was 19% for the CDX-011 arm and 14% for
the IC arm, and a direct, positive correlation was observed between increasing
levels of GPNMB expression and increased CDX-011 response rates. Based on these
data, the Company believes CDX-011 has significant promise as a targeted
therapy for patients with breast cancer and high expression of GPNMB, and
especially for those with triple negative disease. “These results are
promising in this heavily pretreated patient population for which there are few
treatment options left. With continued positive results, CDX-011 has the
potential to offer a possible new and important targeted therapy.” . While data
in the study are not yet mature, in patients with high GPNMB in the CDX-011
arm, a trend of improvement in progression-free survival (PFS) has been
observed. In patients with both triple negative breast cancer and high GPNMB
expression, a statistically significant PFS benefit is currently observed
(p=0.0032). Study data continue to mature and patients continue to be followed.
The Company anticipates updating results in the fourth quarter of 2012.“The correlation with GPNMB
expression rates and clinical responses in this study confirms the role of
GPNMB as a potentially new and important cancer target,” said Linda Vahdat, MD,
Professor of Medicine, Chief of Solid Tumor Service and Director of the Breast
Cancer Research Program at Weill Cornell Medical College and the lead
investigator of the EMERGE study. “These results are promising in this heavily
pretreated patient population for which there are few treatment options left.
With continued positive results, CDX-011 has the potential to offer a possible
new and important targeted therapy.”GPNMB has been associated with the
migration, invasion, and metastasis of breast cancer. It is also highly expressed
in triple negative breast cancers where it is associated with increased risk of
recurrence. The Phase 2b EMERGE study required patients’ tissue to have at
least 5% of cells expressing GPNMB at entry and, based on the low threshold for
marker positivity, 99% of patients screened for GPNMB expression met the entry
requirement, allowing for a specific focus on expression pattern subgroups. A
total of 122 patients were treated on the study, with 81 patients (81
evaluable) randomized to the CDX-011 arm and 41 patients (36 evaluable) to the
IC single-agent chemotherapy arm. Greater than 98% of the patient population
across both arms had Stage IV disease. Patients on the CDX-011 arm received a
median of six prior courses of therapy and patients on the IC arm received a
median of five prior courses of therapy. The study overall replicated previous
data in all comers, but subgroup analyses show enrichment for improved outcome
in triple negative and high expressing subsets. Adverse events prominent with
the CDX-011 arm include rash and peripheral neuropathy.*Responses per RECIST
1.1; IC = Investigator’s Choice; CDX-011 arm includes 15 patients who crossed
over to receive CDX-011 treatment after progression on IC; Analysis of best
response excludes patients who discontinued from study without evaluable
post-baseline radiographic imaging (n =15 for CDX-011 arm; n=5 for IC arm);
Analysis of tumor shrinkage excludes additional patients without evaluable
post-baseline imaging of all target lesions (n=5 for CDX-011 arm; n=1 for IC
arm).Thomas Davis, MD, Chief Medical Officer of Celldex Therapeutics,
commented, “The data in all patients, which includes both low and high GPNMB
expression levels, replicates our previous study and shows CDX-011 to have
activity similar to drugs currently approved for advanced breast cancer. The
results in triple negative and high expressing patient populations suggest
these groups are a highly responsive patient subset for targeted treatment with
CDX-011. This result is in contrast with other agents, which tend to have
limited effects in these populations. With a defined patient population for
targeted therapy established for CDX-011, we can now confidently discuss
possible approval paths with the regulators to determine next
steps."Anthony Marucci, President and Chief Executive Officer of Celldex
Therapeutics, concluded, "It is increasingly clear that targeted therapies
will be needed to make meaningful progress in difficult to treat cancers like
advanced and triple negative breast cancer. We have developed a reliable
diagnostic assay that identifies GPNMB expression patterns and levels in breast
cancer, and the results to date from the Phase 2b EMERGE study suggest we have
clearly identified patient populations that have significant potential to benefit
from CDX-011. Together, patients with ≥25% GPNMB expression levels and patients
with triple negative disease account for more than 35% of the total breast
cancer patient population and we believe CDX-011 could play a vital role as a
much needed treatment option for these patients.”Webcast Details:The data will
be presented in a webcast today, May 23, 2012, at 4:30 p.m. ET by Celldex
management. Linda Vahdat, MD, Professor of Medicine, Chief of Solid Tumor
Service and Director of the Breast Cancer Research Program at Weill Cornell
Medical College and the lead investigator of the EMERGE study, will join
Celldex on the webcast to discuss results to date from the study. Accompanying
slides for the webcast will be made available on the Celldex website at the
start of the call.The conference call will be webcast live over the Internet
and can be accessed by logging on to the "News & Events" section
of the Celldex Therapeutics website at www.celldextherapeutics.com. The call
can also be accessed by dialing 800-299-0148 (within the United States ) or 617-801-9711 (outside the United States United States ) or 617-801-6888 (outside the United States
About CDX-011:CDX-011 (glembatumumab
vedotin) is an antibody-drug conjugate (ADC) that consists of a fully-human
monoclonal antibody, CR011, linked to a potent cell-killing drug,
monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a
stable linker system for attaching it to CR011, was licensed from Seattle Genetics,
Inc. The ADC is designed to be stable in the bloodstream. Following intravenous
administration, CDX-011 targets and binds to GPNMB, a specific protein that is
expressed in breast cancer and other tumor types, and which promotes the
migration, invasion and metastasis of breast cancer. Upon internalization into
the targeted cell, CDX-011 is designed to release MMAE from CR011 to produce a
cell-killing effect. CDX-011 has been shown to be well tolerated and active,
with observed objective responses in two positive Phase 1/2 trials in
metastatic breast cancer and advanced melanoma. In May 2010, the U.S. Food and
Drug Administration (FDA) granted Fast Track designation to Celldex’s CDX-011
for the treatment of advanced, refractory/resistant GPNMB-expressing breast
cancer.
About Celldex Therapeutics, Inc.:Celldex
Therapeutics is the first antibody-based combination immunotherapy company.
Celldex has a pipeline of drug candidates in development for the treatment of
cancer and other difficult-to-treat diseases based on its antibody focused
Precision Targeted Immunotherapy (PTI) Platform. The PTI Platform is a
complementary portfolio of monoclonal antibodies, antibody-targeted vaccines
and immunomodulators used in optimal combinations to create novel disease-specific
drug candidates. For more information, please visit
http://www.celldextherapeutics.com.Safe Harbor Statement Under the Private
Securities Litigation Reform Act of 1995: 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
of CDX-011 or any of our other drug candidates, including rindopepimut (CDX-110),
CDX-1135 (formerly TP10), CDX-1401, CDX-1127, CDX-301, Belinostat and any
future action we or the FDA (or any other regulator) might take with respect to
regulatory approvals. 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, future actions that the FDA and other regulators
might take or not take with respect to CDX-011 or any drug candidate, the
market for CDX-011 or any other drug candidate or assay, future clinical
testing which will be necessary before FDA approval could be sought, our
ability to obtain additional capital on acceptable terms, or at all, including
the additional capital which will be necessary to complete the clinical trials
that we initiated in 2011 and plan to initiate in 2012; our ability to adapt
APC Targeting TechnologyTM to develop new, safe and effective vaccines against
oncology and infectious disease indications; our ability to successfully
complete product research and further development of our programs; the
uncertainties inherent in clinical testing; our limited experience in bringing
programs through Phase 3 clinical trials; our ability to manage research and
development efforts for multiple products at varying stages of development; the
timing, cost and uncertainty of obtaining regulatory approvals; the failure of
the market for the Company's programs to continue to develop; our limited cash
reserves and our ability to obtain additional capital on acceptable terms, or
at all; 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 risks detailed from time to time in the Company's
filings with the Securities and Exchange Commission, including the Company's
Form 10-K for the fiscal year ended December 31, 2011, and its Forms 10-Q and
8-K.
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