Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it
entered an amended agreement providing ApolloBio Corporation
(NEEQ:430187) with the exclusive right to develop and commercialize
VGX-3100, Inovio’s DNA immunotherapy product designed to treat
pre-cancers caused by human papillomavirus (HPV), within Greater
China (China, Hong Kong, Macao, Taiwan).
Based on the new agreement, ApolloBio will make
an upfront payment of $23 million (an increase from the previously
announced amount of $15 million), as well as potential future
payments up to $20 million upon meeting certain milestones.
In addition, Inovio is entitled to receive double-digit tiered
royalty payments on sales. As part of the new terms which replace
the previous amendments to this agreement that were announced on
November 2, 2017, the parties have agreed to terminate ApolloBio’s
right to purchase Inovio stock. This collaboration of VGX-3100
encompasses the treatment and/or prevention of pre-cancerous HPV
infections and HPV-driven dysplasias (including cervical, vulvar
and anal pre-cancers) and excludes HPV-driven cancers and all
combinations of VGX-3100 with other immunostimulants. The agreement
also provides for potential inclusion of the Republic of Korea
during the next three years.
Dr. J. Joseph Kim, Inovio’s President and Chief
Executive Officer, said, “ApolloBio is an excellent partner that
brings significant capabilities and expertise relating to product
development, the Chinese regulatory landscape, and the healthcare
marketplace in China. We are pleased to move forward with an
agreement that preserves the best interest for our shareholders by
obtaining a greater upfront non-dilutive cash license fee of $23
million and removing the equity provisions. In addition, this
collaborative agreement with ApolloBio could potentially accelerate
our overall global VGX-3100 efforts by accessing clinical study
patients in China. We expect this deal to close in the first
quarter of 2018.”
Dr. Weiping Yang, Chief Executive Officer of
ApolloBio, said, “This license and collaboration agreement marks
our determination to introduce late stage innovative new drugs to
meet severely unmet medical needs within the Greater China region.
We are excited at the potential for VGX-3100 to address multiple
indications within HPV-associated pre-cancer, and we very pleased
to be launching this strategic collaboration with Inovio, an
innovative global biotechnology partner.”
About VGX-3100
VGX-3100 is an HPV-specific immunotherapy that
is being developed as a non-surgical treatment for high-grade
cervical dysplasia and related underlying persistent HPV infection.
VGX-3100 works in vivo to activate functional, antigen-specific,
CD-8 T-cells to clear persistent HPV 16/18 infection and cause
regression of pre-cancerous cervical dysplasia. In a phase 2b
trial, VGX-3100 demonstrated clinical efficacy and was generally
well tolerated, without the side effects and obstetric risks
associated with surgical excision. VGX-3100 is a first-in-class
HPV-specific immunotherapy that targets the underlying cause of
cervical dysplasia, providing an opportunity for women to reduce
their risk of cervical cancer without undergoing an invasive
surgical procedure.
About HPV and Cervical
Dysplasia
HPV is the most common sexually transmitted
infection and is the main cause of cervical cancer, which kills
more than 250,000 women every year worldwide. Among the 300 million
women currently infected with HPV, 500,000 will be diagnosed with
cervical cancer each year. Two types of HPV (HPV 16 and HPV 18)
cause 70% of cervical cancer cases. High-grade cervical dysplasia
is also caused by persistent HPV infection and is a pre-cancerous
condition that can progress to cervical cancer if left untreated.
Globally the number of high-grade cervical dysplasia cases is
estimated to be in the range of 10 million.
Currently there are no approved medical
treatments for persistent HPV infection or cervical dysplasia. The
primary treatment for high-grade cervical dysplasia is surgical
excision of the pre-cancerous lesion and a margin of healthy
cervical tissue. Because surgical excision does not treat the
underlying HPV infection that causes cervical dysplasia, there is a
10-16% risk of disease recurrence. Women with persistent HPV
infection after surgical excision remain at high risk for cervical
cancer. In addition, surgical treatment is associated with pain and
cramping, and a risk for post-surgical bleeding, infection, and
pre-term delivery and miscarriages during future pregnancies.
About ApolloBio
Corp.
ApolloBio Corp. (NEEQ:430187) is a leading
Chinese biomedical company committed to research and development of
innovative new medicines, accessing such new medicines through
in-licensing, and additionally providing medical services.
ApolloBio Corp. is focused on pharmaceutical products with
significant market potential in China in the field of oncology;
providing efficient access for American biomedical companies to
enter into the Chinese market; and aiming to bring the newest and
best medicines across the globe to the Chinese people. For more
information, visit www.apollobio.com.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, Regeneron, Genentech, The Wistar Institute, University
of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life
Sciences, ApolloBio Corporation, Drexel University, NIH, HIV
Vaccines Trial Network, National Cancer Institute, U.S. Military
HIV Research Program, and Laval University. For more information,
visit www.inovio.com.
This press release contains certain
forward-looking statements relating to our business, including our
plans to develop electroporation-based drug and gene delivery
technologies and DNA vaccines, our expectations regarding our
research and development programs, including the planned initiation
and conduct of clinical trials and the availability and timing of
data from those trials, and the sufficiency of our capital
resources. Actual events or results may differ from the
expectations set forth herein as a result of a number of factors,
including uncertainties inherent in pre-clinical studies, clinical
trials and product development programs, the availability of
funding to support continuing research and studies in an effort to
prove safety and efficacy of electroporation technology as a
delivery mechanism or develop viable DNA vaccines, our ability to
support our pipeline of SynCon® active immunotherapy and vaccine
products, the ability of our collaborators to attain development
and commercial milestones for products we license and product sales
that will enable us to receive future payments and royalties, the
adequacy of our capital resources, the availability or potential
availability of alternative therapies or treatments for the
conditions targeted by the company or its collaborators, including
alternatives that may be more efficacious or cost effective than
any therapy or treatment that the company and its collaborators
hope to develop, issues involving product liability, issues
involving patents and whether they or licenses to them will provide
the company with meaningful protection from others using the
covered technologies, whether such proprietary rights are
enforceable or defensible or infringe or allegedly infringe on
rights of others or can withstand claims of invalidity and whether
the company can finance or devote other significant resources that
may be necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of the company's technology by
potential corporate or other partners or collaborators, capital
market conditions, the impact of government healthcare proposals
and other factors set forth in our Annual Report on Form 10-K for
the year ended December 31, 2016, our Form 10-Q for the
period ended September 30, 2017, and other regulatory filings we
make from time to time. There can be no assurance that any product
candidate in Inovio's pipeline will be successfully developed,
manufactured or commercialized, that final results of clinical
trials will be supportive of regulatory approvals required to
market licensed products, or that any of the forward-looking
information provided herein will be proven accurate.
Forward-looking statements speak only as of the date of this
release, and Inovio undertakes no obligation to update or revise
these statements, except as may be required by law.
CONTACTS:Investors: Ben Matone,
Inovio, 484-362-0076,
ben.matone@inovio.com
Media: Jeff Richardson, Inovio, 267-440-4211,
jrichardson@inovio.com
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