Celldex Therapeutics Receives Fast-Track Designation For CDX-110, A Novel EGFRvIII Vaccine For Glioblastoma

Celldex Therapeutics
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation to Celldex’s CDX-110 for the treatment of
EGFRvIII expressing Glioblastoma Multiforme (GBM). GBM is the most common
and aggressive form of primary brain cancer and carries a very poor
prognosis with current therapy. CDX-110 is an immunotherapy that targets
the tumor-specific growth promoter EGFRvIII that can be expressed by GBM.

In the ACTIVATE Phase 2a study, GBM patients treated with CDX-110
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. GBM
that recurred after treatment with CDX-110 consistently lost EGFRvIII
expression with its aggressive growth signal. 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. 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 2/3 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 recently announced that CDX-110 has also been granted
Orphan Drug Status by the FDA. Celldex Therapeutics announced a definitive
merger agreement with AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) in
October 2007.

“Fast Track status acknowledges CDX-110′s potential to fill an unmet
need for glioblastoma patients and gives it priority within the FDA,” said
Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics.
“Confirmation of the promising results we’ve already observed is a high
priority at Celldex, as it is within the brain cancer community in
general.”

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 Fast Track Drug Designation

Under the FDA Modernization Act of 1997, designation as a Fast Track
product for a new drug or biological products means that FDA will take such
actions as are appropriate to expedite the development and review of the
application for approval of such product. FDA may also evaluate for filing
and commence review of portions of an application for approval of a Fast
Track product under certain conditions.

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, Inc.
celldextherapeutics

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