Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it
has entered into a collaboration and license 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). The agreement provides for potential inclusion of
the Republic of Korea three years following the effective date.
Under the collaboration and license agreement,
Inovio will receive $15 million in upfront and near term payments
comprising an initial $3 million signing fee and a $12 million
milestone upon lifting of the VGX-3100 phase 3 pre-initiation
clinical hold by the FDA. Under a separate equity agreement,
ApolloBio will invest in Inovio common stock subsequent to lifting
of the clinical hold at a volume weighted average price
encompassing a trading period prior to and following the lifting of
the clinical hold. The aggregate investment, which is expected to
be completed in the first half of 2017, will not exceed $35 million
and may be a lower amount such that ApolloBio will not be the
largest shareholder in Inovio. ApolloBio will fund all clinical
development costs within the licensed territory, and will pay
Inovio up to $20 million based upon the achievement of certain
regulatory milestones in the US, China and Korea, and double digit
royalties on net sales of VGX-3100. The agreements are subject to
People’s Republic of China (PRC) corporate and regulatory
approvals, and payments are subject to PRC currency approvals.
This collaboration on VGX-3100 encompasses the
treatment and/or prevention of pre-cancerous HPV infections and
HPV-driven dysplasias, and excludes HPV-driven cancers and all
combinations of VGX-3100 with other immunostimulants.
Dr. J. Joseph Kim, Inovio’s President and Chief
Executive Officer, said, “As Inovio continues to focus on the path
to regulatory approvals and commercialization strategies in the
U.S. and European countries, this agreement opens up Greater China
for our lead program and first phase III product. We believe that
ApolloBio is a strong partner that brings significant capabilities
and expertise relating to product development, the Chinese
regulatory landscape, and the healthcare market in China.”
Dr. Weiping Yang, Chief Executive Officer of
ApolloBio Corporation, said, “We are delighted to begin 2017 with a
strategic collaboration with Inovio. VGX-3100 is the world’s first
therapeutic vaccine being developed for HPV pre-cancers. This
collaboration, license and equity investment marks our
determination to introduce late stage innovative new drugs to meet
severely unmet medical needs within the Greater China region.”
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 II
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
Corporation
ApolloBio Corporation (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 three major fields of
oncology, liver disease, and cardio-cerebrovascular disease;
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, The Wistar Institute, University of Pennsylvania, DARPA,
GeneOne Life Science, Plumbline Life Sciences, 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 the
agreements with ApolloBio, our plans to develop
electroporation-based drug and gene delivery technologies and DNA
vaccines, our expectations regarding our research and development
programs and our capital resources. Actual events or results may
differ from the expectations set forth herein as a result of a
number of factors, including the timing of the lifting of the
VGX-3100 phase 3 pre-initiation clinical hold, receipt of by
ApolloBio of corporate and PRC regulatory approvals, uncertainties
inherent in pre-clinical studies, clinical trials and product
development programs, including VGX-3100, 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 broad 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, 2015, our Form 10-Q for the quarter
ended September 30, 2016, and other regulatory filings
from time to time. There can be no assurance that the approvals
required under the ApolloBio agreements will be obtained, that
VGX-3100 or any other product in Inovio's pipeline will be
successfully developed or manufactured, that final results of
clinical studies for VGX-3100 will be supportive of regulatory
approvals required to market licensed products, including in
Greater China, or that any of the forward-looking information
provided herein will be proven accurate.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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