Significant Tumor-Specific Immune Response Observed in AVANT's Phase 2 Trial Evaluating CDX-110 with Temozolomide for Treatment
15 Aprile 2008 - 10:05PM
Business Wire
Celldex Therapeutics (a wholly-owned subsidiary of AVANT
Immunotherapeutics, Nasdaq: AVAN) announced today that new data
from the Phase 2 ACT II study in glioblastoma multiforme (GBM)
suggest that temozolomide, the standard chemotherapy agent for this
disease, may potentiate the effect of AVANT�s vaccine candidate
CDX-110. These data were presented in a late-breaking presentation
at the annual meeting of the American Association for Cancer
Research (AACR) in San Diego, California. All patients vaccinated
with CDX-110 in the Phase 2a ACT II extension study showed a
tumor-specific immune response, a significant improvement over
previous vaccines and over CDX-110 alone. Patients vaccinated in
conjunction with the daily temozolomide (TMZ) dose had a
statistically significant increase in anti-EGFRvIII antibody titers
(P=0.028) compared to patients that received the standard 200 mg/m2
dose of TMZ. In addition, the Delayed Type Hypersensitivity
response (DTH) following vaccination was also greater in the
patients receiving the continuous 21 day TMZ dose (P=0.05). Early
Time to Progression (TTP) and Overall Survival (OS) data also look
very promising. Contrary to conventional scientific expectation,
these data suggest that chemotherapy enhances the induction of a
vaccine specific immune response, and that daily chemotherapy may
further enhance the vaccine�s effect. �These fascinating results
may represent a new paradigm in tumor vaccine therapy,� said John
Sampson, M.D., a Neurosurgeon at Duke University and the lead
investigator of the study. �If we can combine the tumor killing
effect of chemotherapy with an enhanced effect from tumor specific
immunotherapy, we may be entering a new era for GBM treatment.� Tom
Davis, AVANT�s Chief Medical Officer, added, �We are very pleased
to see ongoing data confirm our belief that CDX-110 plus TMZ may
improve the prognosis for patients with GBM and expect to present
survival data from this study at ASCO in June. We also eagerly
await the data from AVANT�s currently enrolling randomized Phase
2b/3 study, ACT III, which is designed to confirm the Phase 2a
results.� The Study Dr. John Sampson and colleagues have previously
generated data in the Phase 2a ACTIVATE study suggesting that the
CDX-110 vaccine given alone in the adjuvant setting could lead to a
doubling of survival in patients with newly diagnosed, resected GBM
that expresses EGFRvIII, a proprietary tumor specific variant of
the EGFR protein. Traditional scientific thought would suggest that
chemotherapy, particularly if given daily, would undermine the
effect of a vaccine. Based upon preclinical data suggesting that
temozolomide (TMZ), a standard treatment for GBM, might actually
improve the effect of CDX-110, Dr. Sampson enrolled 21 patients in
the ACT II study. Patients received CDX-110 along with adjuvant
temozolomide on either a monthly or daily regimen, and were
followed for immune responses, Time to Progression (TTP) and
Overall Survival (OS). About the CDX-110 Vaccine 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, 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
Glioblastoma Multiforme (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 malignancies. AVANT has
exclusive worldwide 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 AVANT
Immunotherapeutics, Inc. AVANT Immunotherapeutics, Inc. is a
NASDAQ-listed company discovering and developing innovative
vaccines and targeted immunotherapeutics for the treatment of
cancer, infectious and inflammatory diseases. AVANT and Celldex
Therapeutics, Inc. combined in the first quarter of 2008. AVANT
focuses on the use of tumor-specific targets and human monoclonal
antibodies (mAbs) to precisely deliver therapeutic agents through
its novel �targeted immunization� approach. In addition, AVANT is
also exploiting its access to proprietary human antibody technology
for development of therapeutics monoclonal antibodies (mAbs).
AVANT�s deep product pipeline consists of products in varying
stages of development, with its lead candidate, CDX-110, currently
undergoing evaluation in a Phase 2b/3 clinical trial in newly
diagnosed glioblastoma multiforme, one of the most aggressive forms
of brain cancer. AVANT also has several product candidates in its
development pipeline including: CDX-1307, a product based on its
proprietary APC Targeting Technology�, which is in two Phase 1
clinical trials for patients with advanced pancreatic, bladder,
breast and colon cancer; TP10, a complement inhibitor, in
development for transplantation and other indications; and Three
candidates based on its oral, rapidly-protecting, single-dose and
temperature-stable vaccine technology, including combination
vaccines for travelers, the military and global health needs. AVANT
has three commercialized products, including Rotarix� (partnered
with GSK) for the prevention of rotavirus infection and two human
food safety vaccines for reducing salmonella infection in chickens
and eggs. Additional information on AVANT Immunotherapeutics, Inc.
can be obtained through its website at www.avantimmune.com. Safe
Harbor Statement Under the Private Securities Litigation Reform Act
of 1995: This release includes forward-looking statements that are
subject to a variety of risks and uncertainties and reflect AVANT�s
current views with respect to future events and financial
performance. There are a number of important factors that could
cause the actual results to differ materially from those expressed
in any forward-looking statement made by AVANT. These factors
include, but are not limited to: (1) the successful integration of
the business post-merger, multiple technologies and programs; (2)
the ability to adopt AVANT�s APC Targeting TechnologyTM to develop
new, safe and effective vaccines against oncology and infectious
disease indications; (3) the ability to adapt AVANT�s vectoring
systems to develop new, safe and effective orally administered
vaccines against disease causing agents; (4) the ability to
successfully complete product research and further development,
including animal, pre-clinical and clinical studies, and
commercialization of CDX-110, CDX-1307, CholeraGarde� (Peru-15),
Ty800, ETEC E. coli vaccine, and other products and AVANT�s
expectations regarding market growth; (5) the cost, timing, scope
and results of ongoing safety and efficacy trials of CDX-110,
CDX-1307, CholeraGarde� (Peru-15), Ty800, ETEC E. coli vaccine and
other preclinical and clinical testing; (6) the ability to
negotiate strategic partnerships or other disposition transactions
for AVANT�s cardiovascular programs, including TP10 and CETi; (7)
the ability of AVANT to manage multiple clinical trials for a
variety of product candidates; (8)�the volume and profitability of
product sales of Megan�Vac 1, Megan�Egg and other future products;
(9)�the process of obtaining regulatory approval for the sale of
Rotarix� in major commercial markets, as well as the timing and
success of worldwide commercialization of Rotarix� by our partner,
GlaxoSmithKline or Glaxo; (10)�Glaxo�s strategy and business plans
to launch and supply Rotarix� worldwide, including in the U.S. and
other major markets and its payment of royalties to AVANT; (11)
AVANT�s expectations regarding its technological capabilities and
expanding its focus to broader markets for vaccines; (12) changes
in existing and potential relationships with corporate
collaborators; (13) the availability, cost, delivery and quality of
clinical and commercial grade materials produced at AVANT�s own
manufacturing facility or supplied by contract manufacturers and
partners; (14) the timing, cost and uncertainty of obtaining
regulatory approvals; (15) AVANT�s ability to develop and
commercialize products before competitors that are superior to the
alternatives developed by such competitors; (16) AVANT�s ability to
retain certain members of management;(17) AVANT�s expectations
regarding research and development expenses and general and
administrative expenses; (18) AVANT�s expectations regarding cash
balances, capital requirements, anticipated royalty payments
(including those from Paul Royalty Fund), revenues and expenses,
including infrastructure expenses; (19)�the ability to obtain
substantial additional funding; (20)AVANT�s belief regarding the
validity of our patents and potential litigation; and (21) certain
other factors that might cause AVANT�s actual results to differ
materially from those in the forward-looking statements including
those set forth under the headings �Business,� �Risk Factors� and
Management�s Discussion and Analysis of Financial Condition and
Results of Operations� in each of AVANT�s Annual Report on Form
10-K, its current Reports on Form 8-K, as well as those described
in AVANT�s other press releases and filings with the Securities and
Exchange Commission, from time to time. You should carefully review
all of these factors, and you should be aware that there may be
other factors that could cause these differences. These
forward-looking statements were based on information, plans and
estimates at the date of this press release, and AVANT does not
promise to update any forward-looking statements to reflect changes
in underlying assumptions or factors, new information, future
events or other changes.
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