AVANT Announces Vaccine Adjuvant Licenses with 3M
11 Juni 2008 - 2:00PM
Business Wire
Celldex Therapeutics, Inc. (a wholly-owned subsidiary of AVANT
Immunotherapeutics, Nasdaq: AVAN) today announced multi-year
clinical research collaborations with the 3M to access their
proprietary Immune Response Modifier Resiquimod� (and additional
Toll-Like Receptor 7/8 agonists (TLR)) for clinical study with
Celldex�s proprietary Antigen Presenting Cell (APC) Targeting
Technology�, for use as vaccine adjuvants. �The combination of 3M�s
TLR 7/8 agonists with the APC Targeting TechnologyTM products is
synergistic in itself, and we believe that they can also be used to
create second generation conjugated vaccines that deliver the
vaccine and TLR agonists directly to the immune system within a
single construct,� said Tibor Keler, Ph.D., Chief Scientific
Officer of AVANT Immunotherapeutics. �This collaboration, in
addition to our existing agreement with Oncovir, allows us to
conduct combination studies with clinically tested TLR agonists. We
are now in a position to explore a comprehensive vaccine strategy
that targets multiple individual immune activation pathways based
on the most recent scientific advances.� The foundation of the APC
Targeting TechnologyTM is the ability of the Company�s proprietary
monoclonal antibodies to deliver vaccines directly to professional
APCs, such as dendritic cells and macrophages. Celldex�s APC
Targeting TechnologyTM product candidates can access the immune
system far more efficiently than traditional vaccine approaches,
and can be readily combined with adjuvants to enhance immunity
against cancer or infectious diseases. �We believe that our APC
Targeting TechnologyTM and our collaborative relationship with 3M
and Oncovir provide us with a unique opportunity to develop
combination immunotherapies,� added Thomas Davis, M.D., AVANT�s
Chief Medical Officer. �The preclinical data suggest that
combinations will be more potent, and the immunotherapy field is
eager to see these combination tested. Our ability to license such
adjuvants for comprehensive immunotherapy could open a new era.�
The 3M and Oncovir products will initially be combined with
Celldex�s lead APC Targeting TechnologyTM program, CDX-1307,
currently in phase I studies for patients with incurable breast,
bladder, pancreatic, or colorectal cancer. Additional clinical
programs combining APC Targeting TechnologyTM and TLR agonists are
planned in oncology and infectious disease indications. Celldex
will have the flexibility to use these TLR agonists, alone or in
combination, in conjunction with its novel antibody-targeting
platform. This will enable the Company to uniquely advance its
broad immunotherapy portfolio across a range of disease
indications. About 3M A recognized leader in research and
development, 3M produces thousands of innovative products for
dozens of diverse markets. 3M�s core strength is applying its more
than 40 distinct technology platforms � often in combination � to a
wide array of customer needs. With $24 billion in sales, 3M employs
75,000 people worldwide and has operations in more than 60
countries. About Oncovir Oncovir, Inc is a pharmaceutical
corporation dedicated to the development of nucleic-acid-based
clinical therapies for cancer, infectious, immune, and degenerative
disorders. Based in Washington, DC, Oncovir has been investigating
the use of Hiltonol (Poly ICLC) in a series of clinical studies
toward brain cancer and smallpox virus. About AVANT
Immunotherapeutics, Inc. AVANT Immunotherapeutics and Celldex
Therapeutics combined during the first quarter of 2008. 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 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 exploiting its access to proprietary human
antibody technology for development of therapeutic monoclonal
antibodies (mAbs). AVANT�s deep product pipeline consists of
products in varying stages of development, with its lead candidate,
CDX-110, partnered with Pfizer, Inc., 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 five 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� 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 site
on the World Wide Web: http://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 businesses, multiple technologies and programs of AVANT and
Celldex; (2) the ability to adopt AVANT�s APC Targeting
TechnologyTM to develop new, safe and effective vaccines against
oncology and infectious disease indications, as well as our ability
to develop combination immunotherapies; (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)
Pfizer�s and our strategy and business plans concerning the
continued development and commercialization of CDX-110; (12)
AVANT�s expectations regarding its technological capabilities and
expanding its focus to broader markets for vaccines; (13) changes
in existing and potential relationships with corporate
collaborators; (14) 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; (15) the timing, cost and uncertainty of obtaining
regulatory approvals; (16) AVANT�s ability to develop and
commercialize products before competitors that are superior to the
alternatives developed by such competitors; (17) AVANT�s ability to
retain certain members of management;(18) AVANT�s expectations
regarding research and development expenses and general and
administrative expenses; (19) AVANT�s expectations regarding cash
balances, capital requirements, anticipated royalty payments
(including those from Paul Royalty Fund), revenues and expenses,
including infrastructure expenses; (20)�the ability to obtain
substantial additional funding; (21) AVANT�s belief regarding the
validity of our patents and potential litigation; and (22) 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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