Pfizer and AVANT Enter into Licensing and Development Agreement for Novel Therapeutic Vaccine Candidate for Brain Cancer
16 Abril 2008 - 3:37PM
Business Wire
Pfizer, Inc (NYSE: PFE) and AVANT Immunotherapeutics (Nasdaq:
AVAN), acting through its wholly-owned subsidiary Celldex
Therapeutics, Inc. today announced that they have entered into an
agreement under which Pfizer will be granted an exclusive worldwide
license to a therapeutic cancer vaccine candidate, CDX-110, in
Phase 2 development for the treatment of glioblastoma multiforme
(GBM). This agreement also gives Pfizer exclusive rights to the use
of EGFRvIII vaccines in other potential indications. CDX-110, which
has been granted both Fast Track and Orphan Drug designations by
the U.S. Food and Drug Administration (FDA), 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 in certain tumor types. EGFRvIII is only expressed
in cancer cells and not in normal tissue and is a transforming
oncogene that can directly contribute to cancer cell growth, as it
does in about 40 percent of GBM tumors. �We are excited about the
potential for CDX-110 and intend to partner with AVANT and academic
physician-scientists to investigate this novel vaccine candidate
with the hope of providing patients and doctors with a new
treatment option for this devastating disease,� said Dr. Briggs
Morrison, Senior Vice President for Clinical Development at Pfizer.
Under the licensing and development agreement, Pfizer will make an
upfront payment to AVANT of $40 million and will make a $10 million
equity investment in AVANT. Pfizer will fund all development costs
for these programs. AVANT is also eligible to receive milestone
payments exceeding $390 million for the successful development and
commercialization of CDX-110 and additional EGFRvIII vaccine
products, as well as double-digit royalties on any product sales.
The agreement is subject to approval under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 (as amended) and is expected to
close in the second quarter of 2008. �This partnership advances the
therapeutic potential for CDX-110, particularly for patients with
GBM. We are very pleased to initiate this relationship to expand
our clinical development activities for GBM and toward other
cancers,� said Ron Newbold, Ph.D., Senior Vice President of
Business Development of AVANT Immunotherapeutics. Una Ryan, CEO of
AVANT, added, �We see this as an important milestone for the
immunotherapy field, and we look forward to Pfizer�s commitment to
help even more cancer patients in the future.� CDX-110 is designed
to induce or enhance the body�s immune responses against EGFRvIII
resulting in destruction of tumor cells that express the variant
receptor. Early efficacy and safety data from single arm Phase 2
clinical trials of CDX-110 in combination with the current standard
treatment for patients with GBM are very encouraging.
Progression-free survival and overall survival data from these
trials compare very favorably with historical control data. A
randomized Phase 2 trial is ongoing. GBM is the most common and
aggressive form of primary brain tumor, with very poor prognosis.
There are an estimated 10,000 new cases of GBM annually in the
United States, which predominantly affects adults aged 45 to 70.
The current standard treatment for patients with GBM includes
surgical resection, radiotherapy with concurrent temozolomide and
then adjuvant temozolomide chemotherapy. About Pfizer Inc Pfizer
discovers and develops innovative medicines to treat and help
prevent disease for both people and animals. We also partner with
healthcare providers, governments and local communities around the
world to expand access to our medicines and to provide better
quality healthcare and health system support. About AVANT
Immunotherapeutics, Inc. AVANT Immunotherapeutics and Celldex
Therapeutics combined during the first quarter of 2008. AVANT 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.
Identification of the potential of EGFRvIII in cancer diagnosis,
prevention and therapy was based on the collaborative efforts of
Dr. Bert Vogelstein and Dr. Albert Wong at Johns Hopkins University
and Dr. Darell Bigner at Duke University. Application of this
discovery toward the development of the CDX-110 vaccine was further
advanced by Dr. John Sampson and his colleagues at the Duke
University Brain Tumor Center in collaboration with Dr. Amy
Heimberger at the MD Anderson Cancer Center. 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 web site http://www.avantimmune.com. For more
information on Pfizer or AVANT please visit www.pfizer.com or
www.avantimmune.com PFIZER DISCLOSURE NOTICE: The information
contained in this release is as of April 16, 2008. Pfizer assumes
no obligation to update any forward-looking statements contained in
this release as the result of new information or future events or
developments. This release contains forward-looking information
about a license agreement between Pfizer Inc. and AVANT
Immunotherapeutics relating to a therapeutic cancer vaccine
candidate, CDX-110, and other potential vaccines and the potential
benefits thereof. This information involves substantial risks and
uncertainties including, among other things, the satisfaction of
the condition to closing the agreement; the uncertainties inherent
in research and development activities; decisions by regulatory
authorities regarding whether and when to approve any drug
applications that may be filed for CDX-110 and other potential
vaccines as well as their decisions regarding labeling and other
matters that could affect the availability or commercial potential
thereof; and competitive developments. A further list and
description of risks and uncertainties can be found in Pfizer�s
Annual Report on Form 10-K for the fiscal year ended December 31,
2007 and in its reports on Form 10-Q and Form 8-K. AVANT DISCLOSURE
NOTICE: 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;(21)
Pfizer�s and our strategy and business plans concerning the
continued development and commercialization of CDX-110; 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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