Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today it has
signed a definitive agreement to acquire all of Bioject Medical
Technologies Inc.’s assets including pioneering needle-free jet
injection technology, devices, and intellectual property. Inovio
will pay Bioject $5.5 million in cash and stock.
Inovio will advance an integrated non-invasive delivery device
combining Bioject’s jet injection technology with Inovio’s new
needle-free, skin-surface electroporation (EP) technology. The
company’s goal is to facilitate preventive immunization using its
DNA vaccines against critical infectious diseases with unmet needs
in large populations. Bioject’s needle-free devices, which use high
pressure gas or springs to propel liquid medicine into skin, have
demonstrated desirable utility, safety, and tolerability attributes
in animals and humans. Under a prior research agreement, Inovio
assessed this technology with its new EP delivery system and
generated compelling antigen expression and immune responses in
animals.
Injecting DNA immunotherapies into tissue alone, irrespective of
the injection method, has not generated potent immune responses in
clinical studies - DNA immunotherapies must enter cells of the
tissue to enable their immune-activating capabilities, which is
limited using syringe or jet injection alone. One of two pillars in
Inovio’s success in achieving clinically relevant efficacy with
induced immune responses is its proprietary EP technology enabling
delivered DNA to be transported into the cells. Inovio’s compelling
data have to date been achieved using intramuscular needle-based
injection and EP, which is well-suited for treating cancers and
infectious diseases. Achieving preventive immunization using DNA
vaccines against challenging infectious diseases in large
populations will also require EP delivery. It would also benefit
significantly from a combined jet injection/electroporation device
capable of reducing administration inconsistency, pain, and
disposables cost associated with needle-based injection in mass
immunizations.
Dr. J. Joseph Kim, Inovio’s CEO, said, “Our current DNA delivery
method is highly effective and already gets the job done. However,
to fully realize the opportunity of mass immunization against
challenging infectious diseases we believed we could create an
additional advantage: that is non-invasive vaccine administration.
Similar to our past acquisitions of Advisys and Inovio AS, this
purchase of Bioject’s superior jet injection technology and
well-positioned patents is an investment in Inovio’s future. Jet
injection alone cannot achieve the utility of DNA vaccines.
However, combined with our new needle-free skin-surface
electroporation delivery technology we believe we can offer a
compelling solution to protect against RSV, ever-changing influenza
strains, and emerging infectious diseases like Zika.”
Inovio’s leadership in advancing DNA immunotherapies delivered
using needle-based injection and electroporation led to the first
reported generation of robust antigen-specific immune responses
correlated to efficacy in a controlled clinical study. Its phase II
data was published in September 2015 in The Lancet. This product,
VGX-3100, for high-grade HPV-related cervical dysplasia, will
advance into phase III in 2016. This approach is being used in
multiple current and imminent clinical studies in cancer and
therapeutic applications for chronic infectious diseases such as
hepatitis B and HIV.
With respect to needle-less vaccine administration, Inovio has
an extensive vaccine pipeline to leverage this technique. It has
ongoing clinical programs for flu, HIV, Ebola, and MERS;
proof-of-principle human data has shown significant immune
responses generated by its universal influenza and HIV DNA
vaccines; and preclinical-stage DNA vaccines target important
diseases such as Zika, dengue, Chikungunya and RSV.
Supporting the goal of non-invasive administration, the U.S.
Army Small Business Innovation Research program recently granted
Inovio $500,000 to further support the development of a
needle-free, non-invasive skin-surface electroporation device for
DNA vaccine delivery.
Inovio will pay Bioject $4.5 million in Inovio stock (price set
by 20 day weighted average share price immediately prior to
closing) and $1.0 million in cash. The closing of this transaction
is subject to approval by Bioject’s shareholders and is expected
approximately 30 days from this announcement.
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. The company is advancing a growing
clinical and preclinical stage product pipeline. Partners and
collaborators include MedImmune, Roche, University of Pennsylvania,
DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines
Trial Network, National Cancer Institute, U.S. Military HIV
Research Program, and University of Manitoba. 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 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 uncertainties inherent in pre-clinical
studies, clinical trials and product development programs
(including, but not limited to, the fact that pre-clinical and
clinical results referenced in this release may not be indicative
of results achievable in other trials or for other indications,
that the studies or trials may not be successful or achieve the
results desired, including safety and efficacy for VGX-3100 and
INO-3112, that pre-clinical studies and clinical trials may not
commence or be completed in the time periods anticipated, that
results from one study may not necessarily be reflected or
supported by the results of other similar studies and that results
from an animal study may not be indicative of results achievable in
human studies), 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 immune therapy and vaccine products, our ability to
advance our portfolio of immune-oncology products independently,
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, our ability to enter into partnerships in
conjunction with our research and development programs, evaluation
of potential opportunities, 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, and other regulatory filings from
time to time. There can be no assurance that any product in
Inovio's pipeline will be successfully developed or manufactured,
that final results of clinical studies 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.
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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