Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported that the
Company’s randomized, Phase 2b METRIC Study of glembatumumab
vedotin compared to Xeloda® (capecitabine) in patients with
metastatic triple-negative breast cancers that overexpress gpNMB
failed to meet its primary endpoint, progression-free survival
(PFS) as assessed by an independent, central reading of patient
scans (Hazard ratio = 0.95; median PFS: glembatumumab vedotin 2.9
months vs. Xeloda 2.8 months; p=0.76). There was no significant
advantage for glembatumumab vedotin in key secondary endpoints,
including overall response rate, duration of response and overall
survival. The glembatumumab vedotin safety profile was consistent
with prior experience.
"Triple-negative breast cancer is a very difficult disease to
treat, and we are extremely disappointed for patients that the
METRIC Study was not successful," said Anthony Marucci, Co-founder,
President and Chief Executive Officer of Celldex Therapeutics. "On
behalf of Celldex, I want to express our gratitude to the METRIC
investigators, patients and families who participated in this
study. Based on these results, we have also made the decision to
discontinue the glembatumumab vedotin program across all
indications and are currently prioritizing our pipeline, which
includes five candidates in ongoing clinical studies. In line with
this, we are evaluating our operational and workforce needs to
extend our financial resources and direct them to continued
pipeline advancement. Once we solidify these plans, we intend to
update investors."
Celldex’s clinical-stage pipeline includes the following
compounds:
- Varlilumab, a CD27 agonist, currently completing a Phase 2
study in combination with Opdivo® in multiple indications with data
expected to be presented at multiple medical meetings in 2018;
- CDX-3379, an ErbB3 inhibitor, which is expected to complete
enrollment in the first stage of a Phase 2 study in combination
with Erbitux® in head and neck cancer during the third quarter of
2018;
- CDX-014, a TIM-1 targeted agent, which is actively enrolling
patients in a Phase 1 study in renal cell and ovarian clear cell
carcinomas;
- CDX-1140, a CD40 agonist, which is actively enrolling patients
in a Phase 1 study in various solid tumors; and,
- CDX-301, a dendritic cell mobilizer, currently being studied in
an investigator-sponsored study in combination with radiation
therapy in advanced non-small cell lung cancer. Data from this
study were presented in a plenary session at the AACR Annual
Meeting on Sunday, April 15, 2018.
Celldex believes its pipeline prioritization and organizational
restructuring efforts will extend financial resources beyond the
guidance issued in the Company’s year-end 2017 earnings press
release and associated filings. The Company plans to provide
revised guidance in its first quarter 2018 financial results in
early May.
Webcast and Conference CallCelldex executives
will host a conference call at 8:00 a.m. ET today to discuss
topline METRIC results. The conference call will be webcast live
over the internet and can be accessed by going to the "Events &
Presentations" page under the "Investors & Media" section of
the Celldex Therapeutics website at www.celldex.com. The call can
also be accessed by dialing (866) 743-9666 (within the United
States) or (760) 298-5103 (outside the United States). The passcode
is 7786951.
A replay of the call will be available approximately two hours
after the live call concludes through April 23, 2018. To access the
replay, dial (855) 859-2056 (within the United States) or (404)
537-3406 (outside the United States). The passcode is 7786951. The
webcast will also be archived on the Company's website.
About METRIC The METRIC study is a randomized
Phase 2b study of glembatumumab vedotin in patients with metastatic
triple-negative breast cancers that overexpress gpNMB. In this
indication, overexpression is defined as greater than or equal to
25% of tumor cells testing positive for gpNMB. Patients were
randomized 2 to 1 to either glembatumumab vedotin or to
capecitabine, also known by the tradename Xeloda®, as a comparator.
In total, 327 patients were enrolled into METRIC. The primary
endpoint of the study is progression-free survival (PFS), which is
defined as the time from randomization to the earlier of disease
progression, assessed based on an independent, central reading of
patient scans, or death due to any cause. The study called for 203
progression events for evaluation of the primary endpoint. The sum
of the data, including the secondary endpoints of response rate,
overall survival, duration of response and safety, are also
important in assessing clinical benefit.
About Glembatumumab Vedotin Glembatumumab
vedotin is a fully human monoclonal antibody-drug conjugate (ADC)
that targets glycoprotein NMB (gpNMB). gpNMB is a protein
overexpressed by multiple tumor types, including breast cancer,
melanoma, lung cancer, uveal melanoma and osteosarcoma. The
gpNMB-targeting antibody, CR011, is linked to a potent cytotoxic,
monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary
technology. Glembatumumab vedotin is designed to be stable in the
bloodstream but to release MMAE upon internalization into
gpNMB-expressing tumor cells, resulting in a targeted cell-killing
effect.
Xeloda® is a registered trademark of Genentech, Inc. Opdivo® is
a registered trademark of Bristol-Myers Squibb. Erbitux® is a
registered trademark of Eli Lilly & Co.
About Celldex Therapeutics, Inc. Celldex is
developing targeted therapeutics to address devastating diseases
for which available treatments are inadequate. Our pipeline
includes antibodies, antibody-drug conjugates and other
protein-based therapeutics derived from a broad set of
complementary technologies which have the ability to engage the
human immune system and/or directly inhibit tumors to treat
specific types of cancer or other diseases. 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 our discontinuation of our glembatumumab
vedotin program across all indications, prioritizing our pipeline,
evaluating our operational and workforce needs to extend our
financial resources, research and development related to our
remaining clinical-stage pipeline and other product candidates, and
our expectations that data will be reported in 2018 with respect to
certain of those programs. These statements are typically preceded
by words such as "believes," "expects," "anticipates," "intends,"
"will," "may," "should," or similar expressions. These
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 continue or complete research and further
development and commercialization of our 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; our ability to
realize the anticipated benefits from the acquisition of Kolltan
and to operate the combined business efficiently; 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 our programs to continue
to develop; our ability to terminate, reduce or cancel any
contractual agreement or arrangement relating to glembatumumab
vedotin; our ability to protect our 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 our drug candidates or programs; 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.
Company Contact:Sarah CavanaughSenior Vice
President, Corporate Affairs & Administration(781)
433-3161scavanaugh@celldex.com
Charles LilesAssociate Director, Investor Relations & Corp
Communications(617) 383-3433cliles@celldex.com
Media Inquiries:Dan BudwickFounder, 1AB
Media(973) 271-6085dan@1abmedia.com
Celldex Therapeutics (NASDAQ:CLDX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Celldex Therapeutics (NASDAQ:CLDX)
Historical Stock Chart
From Sep 2023 to Sep 2024