Celldex Announces Expansion of Phase 2 ReACT Study in Recurrent Glioblastoma

Celldex Announces Expansion of Phase 2 ReACT Study in Recurrent Glioblastoma

PHILLIPSBURG, N.J., Aug. 12, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics,
Inc. (Nasdaq:CLDX) Celldex Therapeutics recently completed enrollment in an
initial cohort (n=25) of Avastin^® (bevacizumab) refractory patients in the
Company's ongoing ReACT study of rindopepimut in EGFRvIII (v3)-positive
glioblastoma (GBM). Based on early evidence of anti-tumor activity, including
stable disease, tumor shrinkage and investigator-reported response, the
Company has decided to add an expansion cohort of approximately 75 patients to
better characterize the potential activity of rindopepimut in this refractory
patient population. Enrollment in the expansion cohort has begun and, like the
initial cohort, will evaluate rindopepimut plus Avastin.

"Patients with GBM who have become refractory to Avastin tend to have very
rapid disease progression," said Thomas Davis, MD, Senior Vice President and
Chief Medical Officer of Celldex Therapeutics. "Based upon preliminary
evidence that rindopepimut may have activity in Avastin refractory GBM, we
have decided to expand the refractory group with the hope of better defining
possible therapeutic effect. We expect to share a formal review of the results
from the initial 25 patients at the Society for Neuro-Oncology Annual Meeting
in November."

ReACT is a Phase 2 study designed to determine if adding rindopepimut to the
standard of care for recurrent glioblastoma, Avastin, improves the outcomes
for patients with recurrent EGFRvIII-positive glioblastoma. As amended, the
ReACT study will now enroll approximately 170 patients across three groups:

  *Group 1 - Avastin naïve, n= apx. 70, enrollment ongoing—patients
    randomized to receive either rindopepimut or KLH (administered as a
    control), each along with Avastin
    
  *Group 2 - Avastin refractory, n= apx. 25, enrollment completed—patients
    receive rindopepimut plus Avastin in a single treatment arm
    
  *Group 2C (C = Confirmatory) - Avastin refractory expansion, n = apx. 75,
    enrollment initiated—patients receive rindopepimut plus Avastin in a
    single treatment arm

Study endpoints include 6 month progression free survival rate, objective
response rate, overall survival and safety and tolerability.

Avastin is a registered trademark of Genentech, a member of the Roche Group.

About Rindopepimut

Rindopepimut is an investigational immunotherapy that targets the tumor
specific oncogene EGFRvIII (v3), a functional and permanently activated
mutation of the epidermal growth factor receptor (EGFR), a protein that has
been well validated as a target for cancer therapy. Expression of EGFRvIII
correlates with increased tumorigenicity in mouse models and poor long term
survival in clinical studies of patients with glioblastoma (GBM). In addition,
EGFRvIII-positive cells are believed to stimulate proliferation of
non-EGFRvIII cells through IL-6 cell-to-cell signaling and to release
microvesicles containing EGFRvIII, which can merge with neighboring cells,
transferring tumor-promoting activity. EGFRvIII expression may also be
associated with tumor stem cells that have been identified in GBM. These stem
cells contribute to resistance to cytotoxic therapy and tumor recurrence.
EGFRvIII is expressed in tumors in about 30% of patients with GBM. It has not
been detected at a significant level in normal tissues; therefore, targeting
of this tumor-specific molecule is not likely to impact healthy tissues.

Three Phase 2 trials of rindopepimut—ACTIVATE, ACT II, and ACT III—have been
completed in newly diagnosed EGFRvIII-positive GBM and have shown consistent
improvements in both overall survival and median progression-free survival.
The most common adverse events for rindopepimut include injection site
reactions, fatigue, rash, nausea and pruritus. Rindopepimut is currently being
studied in two clinical trials in EGFRvIII-positive GBM—an international Phase
3 study called ACT IV in newly diagnosed GBM and a Phase 2 study called ReACT
in recurrent GBM.

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