Celldex Presents Preliminary Cohort Data from Pilot Study of CDX-301 in Allogeneic Hematopoietic Stem Cell Harvest at the 201...
February 20 2016 - 8:00AM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today presented new
clinical data on CDX-301 (recombinant human Flt3 ligand), a potent
hematopoietic cytokine that uniquely expands dendritic cells and
hematopoietic stem cells. An open label, pilot study of CDX-301,
alone and in combination with Mozobil (plerixafor), in
sibling-matched donors for allogeneic hematopoietic stem cell
transplantation (HSCT) recipients who have certain hematologic
malignancies is currently enrolling donor/patient pairs. Early data
were presented in a poster entitled “Preliminary Safety and
Efficacy Data using CDX-301 (Flt3 ligand) as a Sole Agent to
Mobilize Hematopoietic Cells Prior to HLA-matched Sibling Donor
Transplantation” at the 2016 BMT Tandem Meeting, the annual meeting
of the American Society for Blood and Marrow Transplantation
(ASBMT). The poster is available on the “Publications” page of
the “Science” section of the Celldex website.
Three donor/patient pairs showed that CDX-301 given as a single
agent for 5 days was well tolerated and effective at mobilizing
hematopoietic stem cells in healthy donors. The stem cell graft
contained notable increases in naïve lymphocytes and plasmacytoid
dendritic cells compared to administration of G-CSF (granulocyte
colony-stimulating factor) and is consistent with preclinical data
suggesting a possible better outcome for recipients. Notably, no
donors required rescue with either G-CSF or Mozobil in this arm of
the study, and none experienced any grade 3 or 4 adverse events.
Recipients experienced successful engraftment in an expected time
frame. Additional donor/patient pairs are being accrued to a
second, planned cohort in order to assess the potential synergies
and feasibility of combining CDX-301 with Mozobil in this
setting.
“From these data and preclinical studies, CDX-301 appears to be
an effective, targeted approach to mobilization comparable to
G-CSF. With a relatively short course of treatment, we are
observing specificity for mobilized stem cells and a lack of
toxicity, instead of broad cellular mobilization and side effects,”
said Steven Devine, M.D., Professor of Internal Medicine, Division
of Hematology, Department of Internal Medicine, and Program
Director, Blood and Marrow Transplant Program at The Ohio State
Comprehensive Cancer Center.
“CDX-301 shows a favorable safety profile and effectively
mobilizes early stem cells when used alone, and we expect even
greater yields in the next cohort where we combine with Mozobil,”
said Thomas Davis, M.D., Executive Vice President and Chief Medical
Officer of Celldex Therapeutics. “CDX-301 could potentially provide
good engraftment, less graft-versus-host disease and mitigated side
effects, which would be a breakthrough for these patients
undergoing HSCT. We are also looking forward to receiving data from
investigators who are using CDX-301 in other drug combination
studies designed to assess its potential in immunotherapy for
cancer and other indications.”
In addition, CDX-301 has shown impressive results in models of
cancer, infectious diseases, inflammatory/autoimmune diseases and
immune suppression. Celldex believes CDX-301 may hold significant
opportunity for synergistic development in combination with other
proprietary molecules in the Company’s portfolio and in external
development. CDX-301 is in clinical development for cancers in
combination with vaccines, adjuvants, and other treatments that
result in release of tumor antigens to enhance tumor
immunogenicity.
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 2016. 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, Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3161
scavanaugh@celldex.com
Charles Liles
Manager, Investor Relations & Corp Communications
Celldex Therapeutics, Inc.
(781) 433-3107
cliles@celldex.com
Media Inquiries:
Dan Budwick
Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
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