Celldex Therapeutics to Present Data from the ReACT Study at 2015 ASCO Annual Meeting
May 13 2015 - 5:08PM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that
several clinical programs, including the Phase 2 ReACT study of
RINTEGA® (rindopepimut) in patients with recurrent glioblastoma
(GBM), will be presented at the 2015 American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago.
The ReACT presentation will include final analysis of
progression-free survival at 6 months (PFS6) and current data on
overall survival and other endpoints. Data contained in the
published abstract were from an analysis in October 2014. Data to
be presented in the oral session will include comprehensive data
from the study through March 2015.
- Abstract #2009: Data from the ReACT study will be presented by
David A. Reardon, M.D., in an oral presentation entitled "ReACT:
Overall survival from a randomized phase II study of rindopepimut
(CDX-110) plus bevacizumab in relapsed glioblastoma" on Sunday, May
31, 2015 at 8:00 a.m. CDT. Dr. Reardon, Clinical Director, Center
for Neuro-Oncology, Dana-Farber Cancer Center; Associate Professor
of Medicine, Harvard Medical School; and President of the Society
for Neuro-Oncology, as well as the lead investigator of the ReACT
study, will speak during the Clinical Science Symposium
"Immunotherapy for Central Nervous System Tumors: Biomarkers and
Novel Data."
- Abstract #TPS1110: The Phase 2b METRIC study will be presented
in a clinical trial in progress session as a poster entitled
"METRIC: A randomized international study of the antibody-drug
conjugate glembatumumab vedotin (GV or CDX-011) in patients (pts)
with metastatic gpNMB-overexpressing triple-negative breast cancer
(TNBC)" on Saturday, May 30, 2015 from 8:00 a.m. to 11:30 a.m.
- Abstract #TPS3105: Data from an investigator-sponsored, Phase
1/2 study of CDX-301, a potent hematopoietic cytokine that
stimulates the expansion and differentiation of hematopoietic stem
cells and dendritic cells, will be presented as a poster entitled
"In Situ Vaccine for Low-Grade Lymphoma: Combination of
Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy" on
Saturday, May 30, 2015 from 8:00 a.m. to 11:30 a.m.
RINTEGA® is a registered trademark of Celldex Therapeutics.
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 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; our ability to maintain and
derive benefit from the Breakthrough Therapy Designation for
RINTEGA, 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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