Celldex Therapeutics
announced 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:
celldextherapeutics.
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, sec, 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.
Celldex Therapeutics
celldextherapeutics