Celldex Therapeutics Announces Orphan Drug Designation for CDX-110, a Novel
EGFRvIII Vaccine for Glioblastoma Multiforme
Celldex also receives approval from Health Canada to open clinical sites and
establishes a collaboration with the National Cancer Institute
PHILLIPSBURG, N.J., Dec. 7 /PRNewswire/ -- Celldex Therapeutics announced
today that the U.S. Food and Drug Administration (FDA) has granted orphan drug
designation for Celldex's CDX-110 for the treatment of EGFRvIII expressing
Glioblastoma Multiforme (GBM). GBM is the most common and aggressive form of
brain cancer. CDX-110 is an immunotherapy that targets the tumor-specific
growth promoter EGFRvIII. Celldex Therapeutics announced a definitive merger
agreement with AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) in October 2007.
In the ACTIVATE phase IIa study, CDX-110 treated GBM patients showed a
median survival time of 30 months, more than a 100 percent increase in
survival, versus the historical control's median of 14.5 months. The study
has demonstrated a median time-to-progression of 13 months (p=0.0001) versus
the historical control's median of 6.4 months. An extension study, ACT II,
which combines CDX-110 with chemotherapy in a similar patient population, has
not yet reached median time-to-progression or survival. However, preliminary
progression free survival (PFS) and overall survival (OS) data in ACT II look
very similar to the ACTIVATE experience, and the data suggest that
chemotherapy and CDX-110 can be administered concurrently while still
maintaining strong immune responses.
In September, Celldex randomized its first patient into ACT III, a
definitive Phase II/III randomized study of CDX-110 with radiation and
temozolomide in patients with newly-diagnosed GBM. The clinical trial is
investigating the anticancer activity, impact on survival, and safety of the
addition of CDX-110 vaccine to standard of care, versus standard of care
alone. Celldex has currently enlisted 18 clinical centers throughout the
United States, and also recently received approval from Health Canada to open
enrollment in Canada. Furthermore, The National Cancer Institute (NCI) has
agreed to collaborate with Celldex in expanded clinical development of CDX-110
under a Clinical Trials Agreement.
"Obtaining orphan designation for CDX-110 is an important milestone for
Celldex," said Thomas Davis, M.D., Chief Medical Officer of Celldex
Therapeutics. "Approval to expand clinical research into Canada and the
scientific and clinical collaboration from the National Cancer Institute all
promote our ability to fully explore the promise of CDX-110."
About CDX-110
CDX-110 is an investigational immunotherapy that targets the tumor
specific molecule EGFRvIII, a functional variant of the epidermal growth
factor receptor (EGFR), which is a protein that has been well validated as a
target for cancer therapy. This particular variant, EGFRvIII occurs in about
40 percent of Glioblastoma Multiforme (GBM) patients. It was discovered in a
collaborative effort between Dr. Bert Vogelstein and Dr Albert Wong at Johns
Hopkins University and Dr. Darell Bigner at Duke University. Unlike EGFR,
EGFRvIII is not present in normal tissues, suggesting this target will enable
the development of a tumor-specific therapy for cancer patients. Furthermore,
EGFRvIII is a transforming oncogene that can directly contribute to cancer
cell growth. While originally discovered in GBM, the most common and
aggressive form of brain cancer, the expression of EGFRvIII has also been
observed in various other cancers such as breast, ovarian, metastatic
prostate, colorectal, and head & neck cancers. Celldex has exclusive rights
to EGFRvIII vaccines and is pursuing the development of CDX-110 for GBM
therapy, as well as in other cancers through additional clinical studies.
About Orphan Drug Designation
Orphan drug designation grants special status to promising new therapies
that treat rare diseases or conditions affecting fewer than 200,000 people in
the United States and entitles seven years of market exclusivity.
Additionally, the sponsor of the product is offered incentives which include
eligibility for research grants, certain tax benefits, protocol assistance and
possible exemptions or reductions of certain regulatory fees during
development or at a time of market approval.
About Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc. is a biotechnology company focused on
developing therapeutic vaccines that target and stimulate the body's immune
system for the treatment of cancer, infectious and autoimmune diseases.
Celldex has three product candidates already in or about to enter clinical
development targeting multiple cancers and Hepatitis B. Four additional
product candidates are in preclinical development for cancer and autoimmune
disease. Celldex's proprietary technology platform uses fully human
monoclonal antibodies administered directly to patients to target and
stimulate dendritic cells - key cells within the immune system. The Company is
headquartered in Phillipsburg, New Jersey. On October 22, 2007, Celldex and
AVANT Immunotherapeutics, Inc. announced that they had signed a definitive
merger agreement. The all-stock transaction, approved by both companies'
Boards of Directors, will combine Celldex and Avant. Closing of the merger is
contingent upon a vote of approval by the current stockholders of AVANT at a
special meeting expected to take place in the first quarter 2008. For more
information, please visit the website: http://www.celldextherapeutics.com.
Additional Information about the Merger and Where to Find It
This communication contains "forward-looking" statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements are typically preceded by words such as "believes," "expects,"
"anticipates," "intends," "will," "may," "should," or similar expressions.
These forward-looking statements are subject to risks and uncertainties that
may cause actual future experience and results to differ materially from those
discussed in these forward-looking statements. Important factors that might
cause such a difference include, but are not limited to, costs related to the
Merger, failure of AVANT's stockholders to approve the Merger; AVANT's or
Celldex's inability to satisfy the conditions of the Merger; AVANT's inability
to maintain its NASDAQ listing; the risk that AVANT's and Celldex's businesses
will not be integrated successfully; the combined company's inability to
further identify, develop and achieve commercial success for new products and
technologies; the possibility of delays in the research and development
necessary to select drug development candidates and delays in clinical trials;
the risk that clinical trials may not result in marketable products; the risk
that the combined company may be unable to successfully secure regulatory
approval of and market its drug candidates; the risks associated with reliance
on outside financing to meet capital requirements; risks associated with
Celldex's new and uncertain technology; risks of the development of competing
technologies; risks related to the combined company's ability to protect its
proprietary technologies; risks related to patent-infringement claims; risks
of new, changing and competitive technologies and regulations in the U.S. and
internationally; and other events and factors disclosed previously and from
time to time in AVANT's filings with the Securities and Exchange Commission,
including AVANT's Annual Report on Form 10-K for the year ended December 31,
2006. The companies do not undertake any obligation to release publicly any
revisions to such forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.
This communication may be deemed to be solicitation material in respect of
the proposed merger of AVANT and Celldex. In connection with the proposed
merger, AVANT and Celldex intend to file relevant materials with the SEC,
including AVANT's joint registration statement/proxy statement on Form S-4.
SHAREHOLDERS OF AVANT ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE
SEC, INCLUDING AVANT'S PROXY STATEMENT, BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders
will be able to obtain the documents free of charge at the SEC's web site,
http://www.sec.gov, and AVANT shareholders will receive information at an
appropriate time on how to obtain transaction-related documents for free from
AVANT. Such documents are not currently available. Participants in the
Solicitation The directors and executive officers of AVANT and Celldex may
be deemed to be participants in the solicitation of proxies from the holders
of AVANT common stock in respect of the proposed transaction. Information
about the directors and executive officers of AVANT is set forth in the proxy
statement for AVANT's most recent 10-K, which was filed with the SEC on March
16, 2007. Investors may obtain additional information regarding the interest
of AVANT and its directors and executive officers, and Celldex and its
directors and executive officers in the proposed transaction by reading the
proxy statement regarding the acquisition when it becomes available.
SOURCE Celldex Therapeutics
Thomas Davis, Chief Medical Officer, Celldex Therapeutics, Inc.,
+1-908-454-7120, or Dan Budwick of BMC Communications, +1-212-477-9007 x14,
for Celldex Therapeutics
