Roche and Inovio Pharmaceuticals partner on Inovio's prostate cancer and hepatitis B immunotherapy products
BASEL, Switzerland and BLUE BELL, Pa.,
Sept. 10, 2013 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) and
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that they
have entered into an exclusive worldwide license agreement to research,
develop and commercialize Inovio's highly-optimized, multi-antigen DNA
immunotherapies targeting prostate cancer and hepatitis B. The licensed
compounds are currently in preclinical development and have generated
robust T-cell responses in animal models.
Roche acquired an exclusive license for Inovio's DNA-based vaccines
INO-5150 (targeting prostate cancer) and INO-1800 (targeting hepatitis
B) as well as the use of Inovio's CELLECTRA® electroporation technology
for delivery of the vaccines. Roche also obtained an option to license
additional vaccine opportunities in connection with a collaborative
research program in oncology. Roche and Inovio will collaborate to
further develop INO-5150 and INO-1800.
Under the terms of the agreement, Roche will make an upfront payment of USD $10 million
to Inovio. Roche will also provide preclinical R&D support and
payments for near-term regulatory milestones as well as payments upon
reaching certain development and commercial milestones potentially up to
USD $412.5 million. Additional
development milestone payments could also be made to Inovio if Roche
pursues other indications with INO-5150 or INO-1800. In addition,
Inovio is entitled to receive up to double-digit tiered royalties on
product sales.
Commenting on the deal, Hy Levitsky, Head of Cancer Immunology
Experimental Medicine at Roche, said: "At Roche we are always interested
in finding first-in-class and best-in-class therapies that may become
the next generation treatments for patients with different types of
cancer. INO-5150 will allow promising combination opportunities with the
Roche portfolio, particularly with our emerging cancer immunotherapy
molecules." Janet Hammond, Head of
Infectious Diseases Discovery & Translational Area at Roche, added:
"We are very excited to have this potentially very important and novel
mechanism of action as part of our portfolio as we seek to address the
significant unmet medical need in chronic hepatitis B infection."
"This partnership represents an important milestone in Inovio's
growth and maturing product portfolio. Roche brings to our immunotherapy
candidates its leadership position and track record for developing and
marketing innovative first-in-class therapies," said Dr. J. Joseph Kim,
Inovio's President and CEO. "Collaborating with the world's preeminent
oncology development partner allows us to rapidly advance two of our
promising near-clinical stage immunotherapy products from our product
pipeline as we continue development of our phase II lead product,
VGX-3100, for treatment of HPV-related cancers and dysplasia."
About INO-5150 for Prostate Cancer
Inovio's
dual-antigen synthetic DNA vaccine (INO-5150) targets prostate-specific
membrane antigen (PSMA) and prostate-specific antigen (PSA). A study in
monkeys showed that vaccination with INO-5150 generated strong and
robust T-cell immune responses that were the highest generated by a
PSA-based immunotherapy in animal studies and were similar to the immune
responses generated by VGX-3100, Inovio's phase II-stage therapeutic
HPV vaccine that generated best-in-class T-cell responses in a phase I
study.
Inovio's SynCon® DNA vaccine for prostate cancer was designed with
PSA and PSMA synthetic consensus immunogens based on human and macaque
sequences, resulting in amino acid sequences that differ slightly from
the native human protein. In humans, this novel approach is utilized to
help the body's immune system recognize cancerous cells created in the
body as 'foreign', overcoming the body's self-tolerance of these cells
and mounting an immune response to clear them.
About INO-1800 for Hepatitis B
Inovio has reported
preclinical data showing its hepatitis B vaccine (INO-1800) generated
strong T-cell and antibody responses that led to the elimination of
targeted liver cells in mice. These results indicate this DNA vaccine's
potential to treat hepatitis B infection and prevent further development
of the infection into liver cancer in humans.
In a preclinical study, researchers found the vaccine-specific
T-cells exhibited a killing function, and could migrate to and stay in
the liver and cause clearance of target cells without evidence of liver
injury. This was the first study to provide evidence that intramuscular
immunization can induce killer T-cells that can migrate to the liver and
eliminate target cells.
To provide worldwide rights to Roche, Inovio has re-acquired its
hepatitis B, Asian-country rights from Inovio's international affiliate.
Disease Background
Prostate Cancer
Prostate cancer is the second most
frequently diagnosed cancer of men. Nearly three-quarters of the
registered cases occur in developed countries. Accounting for nearly
300,000 deaths each year, prostate cancer is the sixth leading cause of
death from cancer in men. The development of a new treatment for
prostate cancer would be a significant medical advancement given that
present treatment options (surgery, radiation and hormone deprivation),
while somewhat effective, all carry deleterious side effects and are
often not a long-term cure.
Hepatitis B and Liver Cancer
Hepatitis B is a disease
characterized by inflammation of the liver. The virus is extremely
infectious – 100 times more so than HIV – and 400 million people are
chronically infected worldwide. Hepatitis B contributes to an estimated 1
million deaths worldwide each year.
Liver cancer is the third most common cancer and the most deadly,
killing most patients within five years of diagnosis. About 600,000 new
cases arise each year. One of the major causes and risk factors for
liver cancer is infection by hepatitis B.
About Inovio Pharmaceuticals, Inc.
Inovio is
revolutionizing vaccines to prevent and treat today's cancers and
challenging infectious diseases. Its SynCon® vaccines, in combination
with its proprietary electroporation delivery, are generating
best-in-class immune responses, with therapeutic T-cell responses
exceeding other technologies in terms of magnitude, breadth, and
response rate. Human data to date have shown a favorable safety profile.
Inovio's lead vaccine, a therapeutic against HPV-caused pre-cancers and
cancers, is in phase II. Other phase I and preclinical programs target
prostate, breast, and lung cancers as well as HIV, influenza, malaria
and hepatitis C virus. Partners and collaborators include the University of Pennsylvania,
Merck, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, University of Southampton, US Dept. of
Homeland Security, University of Manitoba and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
About Roche
Headquartered in Basel, Switzerland,
Roche is a leader in research-focused healthcare with combined
strengths in pharmaceuticals and diagnostics. Roche is the world's
largest biotech company, with truly differentiated medicines in
oncology, infectious diseases, inflammation, metabolism and
neuroscience. Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management. Roche's personalised healthcare strategy aims at providing
medicines and diagnostic tools that enable tangible improvements in the
health, quality of life and survival of patients. In 2012 Roche had over
82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
This press release contains certain forward-looking statements
relating to Inovio's partnership with Roche related to Inovio's
Hepatitis B and prostate cancer immunotherapeutic products, in addition
to Inovio's business, including our plans to develop other
electroporation-based drug and gene delivery technologies and DNA
vaccines and our capital resources. Actual events or results may differ
from the expectations set forth herein, including realization of any and
all projected development or sales milestone payments, as a result of a
number of factors, including Roche's change in business resulting in
the amendment or termination of the Agreement, 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, 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, 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, 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, 2012, our Form 10-Q for the quarter ended June 30, 2013,
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.
For further information:
Roche Partnering
Emilie Vincent, Head of Roche Partnering Communications, emilie.vincent@roche.com
Inovio
Investors: Bernie Hertel, Inovio Pharmaceuticals, +1858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, +1 267-440-4211, jrichardson@inovio.com
(Logo: http://photos.prnewswire.com/prnh/20120131/LA44118LOGO)
SOURCE Inovio Pharmaceuticals, Inc.
Labels: collaborations, INO-1800, Inovio, Roche, vaccines in development