Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced it has
closed an agreement providing ApolloBio Corp. (NEEQ:430187) with
the exclusive right to develop, manufacture and commercialize
VGX-3100, Inovio’s DNA immunotherapy product designed to treat
precancers caused by human papillomavirus (HPV), within Greater
China (mainland China, Hong Kong, Macao, Taiwan).
ApolloBio, which has garnered all regulatory and
board approvals for the agreement, will immediately make an upfront
payment to Inovio of $23 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. This collaboration of VGX-3100
encompasses the treatment and/or prevention of precancerous HPV
infections and HPV-driven dysplasias (including cervical, vulvar
and anal precancers) 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, “We are pleased to close this agreement
that opens large markets and brings us $23 million in non-dilutive
cash with future milestone payments and royalties on sales.
ApolloBio is an excellent partner that will provide significant
capabilities and expertise relating to product development, the
Chinese regulatory landscape, and the commercial market in China.
This agreement strengthens and expands our global efforts to
develop VGX-3100.”
“With this license and collaboration agreement
we are now on the path to introduce late-stage innovative new drugs
to meet severely unmet medical needs within the Greater China
region," said Dr. Weiping Yang, Chief Executive Officer of
ApolloBio. "We are excited at the potential for VGX-3100 to address
multiple indications within HPV-associated precancer, and we are
very pleased to launch this strategic collaboration with Inovio, an
innovative global biotechnology partner.”
About VGX-3100
VGX-3100, now in a Phase 3 trial, 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 is designed
to work in vivo to activate functional, antigen-specific, CD8+ T
cells to clear persistent HPV 16/18 infection and cause regression
of precancerous 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, Cervical Cancer, and Cervical
Dysplasia
HPV is the most common sexually transmitted
infection and is the main cause of cervical cancer, which kills
more than 270,000 women every year worldwide. Among the 300 million
women currently infected with HPV, more than 530,000 will be
diagnosed with cervical cancer each year. Two types of HPV (HPV 16
and HPV 18) collectively cause about 70% of cervical cancer cases
worldwide. High-grade cervical dysplasia is also caused by
persistent HPV infection and is a precancerous condition that can
progress to cervical cancer if left untreated. Globally the
prevalence of high-grade cervical dysplasia cases among adult
females age 20 years or higher is estimated to be in the range of
10 to 30 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 (or sometimes ablation) of the precancerous lesion and a
margin of healthy cervical tissue. Because surgical excision or
ablation does not treat the underlying HPV infection that causes
cervical dysplasia, there is about a 10-16% risk of disease
recurrence in the one- to six year-period after treatment. 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, the Parker Institute for Cancer Immunotherapy,
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, our expectations regarding the closing of
the agreement with ApolloBio 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 us or our collaborators, including
alternatives that may be more efficacious or cost effective than
any therapy or treatment that we and our collaborators hope to
develop, issues involving product liability, issues involving
patents and whether they or licenses to them will provide us 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 we can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
our 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, 2017, and other
regulatory filings we make from time to time. There can be no
assurance that any product candidate in our 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 we undertake 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 |
|
|
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Apr 2023 to Apr 2024