Advaxis and FusionVax Sign a Memorandum of Understanding for the License of Advaxis’ ADXS-HPV in Asia
Advaxis,
Inc., (OTCBB: ADXS) (“Advaxis” or the “Company”), a leader in
developing the next generation of immunotherapies for cancer and
infectious diseases, announced that it has entered into a Memorandum of
Understanding (MoU) with FusionVax, Inc. (“FusionVax”) setting forth the
main terms under which Advaxis will, subject to the entry of a
definitive agreement, exclusively license its lead clinical stage
product candidate, ADXS-HPV, to FusionVax for Asia.
FusionVax is a private Taiwan-based biopharmaceutical company developing
immunotherapies for the treatment of HPV-associated cancers. It is
committed to in-licensing and developing early to late phase product
candidates with primary disease targets of cervical cancer and lung
cancer with a secondary focus on treatments for CIN, oropharyngeal
cancers, and genital warts. FusionVax develops its licensed technologies
through collaborations with top academic leaders at prestigious medical
centers in Asia including: National Taiwan University, Taipei Medical
University, and Mackay Memorial Hospital Medical Center.
Dr. HunChi Lin, Chief Executive Officer of FusionVax, commented, "We are
very pleased to have the opportunity to collaborate with Advaxis to
develop vaccines for the treatment of cervical cancer, a cancer that is
the leading cause of the death of Chinese women."
Under the terms of the MoU, Advaxis will exclusively license the rights
to ADXS-HPV to FusionVax for the Asia territory, exclusive of India, for
all indications. In exchange, FusionVax will pay Advaxis an up-front
payment, certain event-based financial milestones, an annual exclusive
licensing fee, and an annual net sales royalty in countries with issued
patents. In exchange for the up-front payment, Advaxis will provide
FusionVax an equal amount of Advaxis common stock. FusionVax will be
responsible for conducting clinical trials and pursuing
commercialization of ADXS-HPV in Asia and, in exchange, Advaxis will pay
FusionVax net sales annual royalty on ADXS-HPV in the U.S. of less than
1%. The companies will share all data generated from their respective
clinical trials.
Under the terms of the MoU, Advaxis and FusionVax will work together
over the next six months to enter into a definitive exclusive licensing
agreement based upon these terms. FusionVax has agreed to place into
escrow a portion of the first event-based milestone pending the
execution of a definitive licensing agreement.
“FusionVax is well-positioned to further develop ADXS-HPV clinically and
to realize its commercial value in Asia across multiple HPV-associated
cancers,” commented Daniel J. O’Connor, Senior Vice President, Chief
Legal and Business Development Officer of Advaxis.
“With five studies currently in the field in four indications, we
continue to broaden our data. This MoU is the first milestone on
Advaxis’ path to future licensing opportunities,” commented Thomas A.
Moore, Chairman and Chief Executive Officer of Advaxis.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next
generation of immunotherapies for cancer and infectious diseases.
Advaxis immunotherapies are based on a novel platform technology using
live, attenuated bacteria that are bio-engineered to secrete
antigen/adjuvant fusion protein(s) designed to redirect the powerful
immune response all human beings have to the bacterium to the
cancer itself.
ADXS-HPV is being evaluated in 5 clinical trials for HPV-associated
diseases: recurrent/refractory cervical cancer (Phase 2, India), locally
advanced cervical cancer (Phase 2, GOG/NCI US study, Clinical Trials.gov
Identifier NCT01266460), CIN 2/3 (Phase 2, US study, Clinical Trials.gov
Identifier NCT01116245), head & neck cancer (Phase 1/2, CRUK
study, Clinical Trials.gov Identifier NCT01598792), and anal cancer
(Phase 1/2, BrUOG study, Clinical Trial.gov Identifier NCT01671488).
Over fifteen (15) distinct constructs are in various stages of
development, developed directly by the Company and through strategic
collaborations with recognized centers of excellence such as: the National
Cancer Institute, Cancer
Research – UK, the Wistar
Institute, the University
of Pennsylvania, the University
of British Columbia, the Karolinska
Institute, Brown
University Oncology Group, and others. For more information please
visit: advaxis.com
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Forward-Looking Statements
This news release contains forward-looking statements, including,
but not limited to: statements regarding ADXS-HPV, its clinical stage
product candidate, and immunotherapies, as well as statements regarding
the entry into a definitive licensing agreement with FusionVax, as well
as Advaxis’ ability to develop ADXS-HPV further clinically and realize
its commercial value in Asia, the generation of additional data
regarding ADXS-HPV, and future licensing opportunities. Such
forward-looking statements are subject to a number of risks and
uncertainties, such as those described in the “Risk Factors” section in
Advaxis’ Annual Report on Form 10-K for the fiscal year ended October
31, 2012, which is available at www.sec.gov,
as well as its other filings with the Securities and Exchange Commission.
Advaxis undertakes no obligation to revise these forward-looking
statements to reflect the events or circumstances after the date hereof
or to reflect the occurrence of unanticipated events, except as required
by law. You are cautioned not to place undue reliance on any
forward-looking statements.