Celldex Therapeutics Initiates Pilot Study in Dense Deposit Disease

Celldex Therapeutics Initiates Pilot Study in Dense Deposit Disease

PHILLIPSBURG, N.J., July 1, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics,
Inc. (Nasdaq:CLDX) today reported that the first patient has been dosed in the
Company's pilot study of CDX-1135 (a soluble form of human complement receptor
type 1) in dense deposit disease (DDD). DDD is an ultra-rare, progressive
kidney disease that ultimately results in kidney failure in the majority of
affected individuals. DDD is caused by dysregulation of the C3 Convertase, a
major early component of the alternative pathway of complement. CDX-1135 has
been shown to inhibit complement activation and has yielded promising results
in an animal model of DDD and in a single patient with DDD that was treated
under a compassionate use protocol.

The open-label study will enroll up to five patients (ages four and older)
from clinical centers across the United States to determine the CDX-1135 dose
level required to normalize alternative complement activity on an individual
patient basis. Potential effects on renal function will also be assessed.
Patients will initially be treated at the University of Iowa under the
leadership of Richard J.H. Smith, MD and Carla M. Nester, MD. If selected
complement levels normalize on therapy, patients may be able to return to
their local treatment center to continue in the study. Dr. Smith, a widely
recognized expert in DDD, is Professor of Otolaryngology and Internal Medicine
and the Director of the Molecular Otolaryngology and Renal Research
Laboratories (MORL) at the University of Iowa. MORL maintains the largest DDD
patient database in the world. Dr. Nester, also a member of MORL, is an
Assistant Professor at the University of Iowa, trained in adult and pediatric
nephrology.

"CDX-1135 is a much needed and exciting entrant to the dense deposit disease
field," said Dr. Smith. "There are currently no treatments and nearly half of
all patients progress to end-stage renal disease within 10 years of
presentation, often spending the rest of their lives on dialysis. In a mouse
model of dense deposit disease, CDX-1135 has been shown to control the
abnormal complement activity and to reduce deposits in the kidneys. Short term
use of CDX-1135 in a patient with dense deposit disease and end-stage renal
disease was well-tolerated and normalized the activity of the alternative
complement pathway. We are optimistic that if we can control complement
activation earlier in the disease course and at a critical step in the
complement pathway, CDX-1135 may be able to restore kidney function and
provide long term disease control—a long-awaited outcome for patients, their
families and physicians."

Dr. Thomas Davis, Chief Medical Officer of Celldex, added, "Based on research
to date in dense deposit disease and other indications, we believe CDX-1135
has the potential to play an important role in complement mediated diseases,
uniquely in indications where the C3 Convertase is very active leading to a
consumption of C3 and deposition of harmful breakdown products onto the
kidney. We look forward to completing this study in dense deposit disease and,
with positive results, given the unmet need for these patients, we will seek
to expand the CDX-1135 program into a larger study in dense deposit disease as
quickly as possible."

About Dense Deposit Disease:

Dense Deposit Disease (DDD) is a rare kidney disease affecting two persons per
million. DDD is caused by uncontrolled activation of the alternative pathway
of complement, which leads to the consumption of the circulating complement
component C3, deposition of C3 and other proteins in the kidneys, and
subsequent damage to kidney function. Approximately 50% of patients with dense
deposit disease progress to end stage renal disease (ESRD) within 10 years of
diagnosis. Patients diagnosed at a younger age (≤ 12 years old) are more
likely to progress to ESRD and progress more rapidly (typically within 4
years). Kidney transplantation is not a viable option because DDD recurs in
virtually all patients who receive a transplant. There are no treatments at
this time for DDD.

About CDX-1135:

CDX-1135 is soluble complement receptor type 1 (sCR1), a recombinant human
protein made in mammalian cell cultures that is a potent inhibitor of
complement activation, including the classical, lectin and alternative
complement pathways, both at the early (C3) and late (C5) activation steps in
these pathways. Previous clinical studies of CDX-1135 in more than 500
patients in other indications have suggested that CDX-1135 has a favorable
safety profile and is a potent inhibitor of the complement pathway. In dense
deposit disease, CDX-1135 has been shown to control the activation of
alternative pathway complement in patient serum samples in vitro. In a mouse
model of DDD, the administration of CDX-1135 was shown to control complement
activation in vivo, preventing the damaging deposition of C3 in the kidneys.
Short term compassionate use of CDX-1135 in a patient with DDD also showed
control of complement abnormalities. This patient was already in renal failure
requiring dialysis and so reversal of disease was not expected. The newly
initiated pilot study is exploring the potential for clinical benefit in
patients with earlier stage DDD, where C3 consumption and deposition play an
important role in disease progression, and where the greatest potential to
restore kidney function and provide long term disease control exists.

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
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 (by Celldex and others) of rindopepimut
(CDX-110), CDX-011, CDX-1135, CDX-1401, CDX-1127, CDX-301, Belinostat and
other products. 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, CDX-011 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; our ability to adapt our APC
Targeting Technology^TM 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
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.

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: Sarah Cavanaugh
         Vice President of IR & Corp Comm
         Celldex Therapeutics, Inc.
         (781) 433-3161
         scavanaugh@celldextherapeutics.com
 
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