Inovio Pharmaceuticals, Inc. (NASDAQ:INO) and Regeneron
Pharmaceuticals, Inc. (NASDAQ:REGN) today announced a clinical
study agreement for a phase 1b/2a immuno-oncology trial. The study
will be conducted by Inovio in patients with newly diagnosed
glioblastoma multiforme (GBM) and will evaluate Regeneron’s PD-1
inhibitor, REGN2810, in combination with Inovio’s INO-5401 T cell
activating immunotherapy encoding multiple antigens and INO-9012,
an immune activator encoding IL-12.
The open-label trial, which is expected to begin
later this year, is designed to evaluate the safety and efficacy of
the combination therapy in approximately 50 patients. The study
will be conducted at 30 U.S. sites and the primary endpoints are
safety and tolerability. The study will also evaluate immunological
impact, progression-free survival and overall survival.
GBM is a devastating disease for both patients
and caregivers. It is the most aggressive brain cancer and its
prognosis is extremely poor, despite a limited number of new
therapies approved over the last ten years. The median overall
survival for patients receiving standard of care therapy is
approximately 15 months and the average five-year survival rate is
less than three percent.
“Regeneron’s approach to oncology includes
evaluating the combination of innovative therapies that act on
diverse pathways and targets,” said Israel Lowy, MD, PhD, Vice
President of Translation Sciences and Oncology, Regeneron. “Using
our PD-1 inhibitor as a therapeutic backbone alongside Inovio’s T
cell-generating therapies offers a new path for exploration and
heightens the potential to develop new, desperately-needed
treatment options for patients.”
“The unmet need for effective therapies in GBM
remains extremely high. Certain immune checkpoint inhibitors have
shown efficacy in certain cancers, but evidence increasingly
suggests that the benefit of checkpoint inhibitors can be enhanced
when used in combination with therapies that generate T cells,”
said David Reardon, MD, Clinical Director of the Center for
Neuro-Oncology at Dana-Farber Cancer Institute and Professor of
Medicine at Harvard Medical School. “Inovio has an innovative
immunotherapy platform which has shown the ability to generate
antigen-specific T cells in disease areas including cancer. We look
forward to exploring the potential of combining a T cell generating
immunotherapy encoding multiple antigens with REGN2810, a PD-1
checkpoint inhibitor.”
Dr. J. Joseph Kim, Inovio's President and Chief
Executive Officer, said, “I am a strong believer in this
combination regimen approach in immuno-oncology: use Inovio
immunotherapies to generate killer T cells to turn ‘cold’ tumors
into ‘hot’ tumors, then block T cell suppression via checkpoint
inhibition. This step with INO-5401 is very important for us in
2017, as we believe INO-5401 has the potential to be a powerful
cancer immunotherapeutic in combination with promising checkpoint
inhibitors such as Regeneron’s REGN2810, and we look forward to
investigating its potential for GBM and multiple other challenging
cancers.”
Under the terms of the agreement, the trial will
be solely conducted and funded by Inovio, based upon a mutually
agreed upon study design, and Regeneron will supply REGN2810.
Inovio and Regeneron will jointly conduct immunological analyses in
support of the study. Regeneron, in collaboration with Sanofi, is
developing REGN2810 both alone and in combination with other
therapies for the treatment of various cancers.
About Glioblastoma
Glioblastoma, also known as glioblastoma
multiforme (GBM), is the most common and aggressive type of brain
cancer. GBM is usually found in the area of the brain which
controls some of the most advanced processes, such as speech and
emotions. GBM treatment is often limited by the tumor location and
ability of a patient to tolerate surgery. Consequently, it is a
particularly difficult cancer to treat. Worldwide there are an
estimated 240,000 cases of brain and nervous system tumors per
year; GBM is the most common and most lethal of these tumors.
About INO-5401
INO-5401 includes Inovio’s SynCon® antigens for
WT1, hTERT and PSMA and has the potential to be a powerful cancer
immunotherapy in combination with checkpoint inhibitors. The
National Cancer Institute previously highlighted WT1, hTERT and
PSMA among a list of attractive cancer antigens, designating them
as high priorities for cancer immunotherapy development. WT1 was at
the top of the list. The hTERT antigen relates to 85 percent of
cancers, and WT1 and PSMA antigens are also widely prevalent in
many cancers.
About Regeneron Pharmaceuticals,
Inc.
Regeneron (NASDAQ:REGN) is a leading
science-based biopharmaceutical company that discovers, invents,
develops, manufactures and commercializes medicines for the
treatment of serious medical conditions. Regeneron commercializes
medicines for eye diseases, high LDL-cholesterol, atopic dermatitis
and a rare inflammatory condition and has product candidates in
development in other areas of high unmet medical need, including
rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
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, 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.
Inovio statementThis 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 the cancer immunotherapy INO-5401,
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, 2016,
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.
Regeneron Forward-Looking Statements and Use of
Digital MediaThis news release includes forward-looking statements
that involve risks and uncertainties relating to future events and
the future performance of Regeneron Pharmaceuticals, Inc.
(“Regeneron” or the "Company"), and actual events or results may
differ materially from these forward-looking statements. Words such
as "anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying words.
These statements concern, and these risks and uncertainties
include, among others, the nature, timing, and possible success and
therapeutic applications of Regeneron's products, product
candidates, and research and clinical programs now underway or
planned, including without limitation Regeneron’s immuno-oncology
program, REGN2810 (Regeneron’s PD-1 inhibitor), and the Phase 1b/2a
clinical trial evaluating the combination therapy consisting of
REGN2810 and Inovio Pharmaceuticals, Inc.’s T cell activator
INO-5401 and immune activator INO-9012 in patients with
newly-diagnosed glioblastoma multiforme (the “GBM Combination
Therapy”); unforeseen safety issues resulting from the
administration of products and product candidates in patients,
including serious complications or side effects in connection with
the use of Regeneron's and its collaborators’ product candidates in
clinical trials, such as the GBM Combination Therapy;
determinations by regulatory and administrative governmental
authorities which may delay or restrict Regeneron's ability to
continue to develop or commercialize Regeneron's products and
product candidates; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's late-stage
product candidates and new indications for marketed products;
ongoing regulatory obligations and oversight impacting Regeneron’s
marketed products, research and clinical programs (such as the
trial evaluating the GBM Combination Therapy), and business,
including those relating to patient privacy; competing drugs and
product candidates that may be superior to Regeneron's products and
product candidates; uncertainty of market acceptance and commercial
success of Regeneron's products and product candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary) on the commercial success of
Regeneron's products and product candidates; the ability of
Regeneron’s collaborators, suppliers, or other third parties to
perform filling, finishing, packaging, labelling, distribution, and
other steps related to Regeneron’s products and product candidates;
coverage and reimbursement determinations by third-party payers,
including Medicare and Medicaid; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its sales or other financial projections
or guidance and changes to the assumptions underlying those
projections or guidance; the potential for any license or
collaboration agreement, including Regeneron's agreements with
Sanofi, Bayer HealthCare LLC, and Teva Pharmaceutical Industries
Ltd. (or their respective affiliated companies, as applicable), as
well as Regeneron’s clinical study agreement with Inovio
Pharmaceuticals, Inc. discussed in this news release, to be
cancelled or terminated without any further product success; and
risks associated with intellectual property of other parties and
pending or future litigation relating thereto, including without
limitation the patent litigation relating to Praluent® (alirocumab)
Injection, the permanent injunction granted by the United States
District Court for the District of Delaware that, if upheld on
appeal, would prohibit Regeneron and Sanofi from marketing,
selling, or commercially manufacturing Praluent in the United
States, the outcome of any appeals regarding such injunction, the
ultimate outcome of such litigation, and the impact any of the
foregoing may have on Regeneron’s business, prospects, operating
results, and financial condition. A more complete description of
these and other material risks can be found in Regeneron's filings
with the United States Securities and Exchange Commission,
including its Form 10-K for the year ended December 31, 2016 and
its Form 10-Q for the quarterly period ended March 31, 2017. Any
forward-looking statements are made based on management's current
beliefs and judgment, and the reader is cautioned not to rely on
any forward-looking statements made by Regeneron. Regeneron does
not undertake any obligation to update publicly any forward-looking
statement, including without limitation any financial projection or
guidance, whether as a result of new information, future events, or
otherwise.
Regeneron uses its media and investor relations
website and social media outlets to publish important information
about the Company, including information that may be deemed
material to investors. Financial and other information about
Regeneron is routinely posted and is accessible on Regeneron’s
media and investor relations website
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Contact:
Inovio:
Investors:
Bernie Hertel,
858-410-3101,
bhertel@inovio.com
Media:
Jeff Richardson,
267-440-4211
jrichardson@inovio.com
Regeneron:
Investors:
Manisha Narasimhan, Ph.D.
+1 (914) 847-5126
manisha.narasimhan@regeneron.com
Media:
Alexandra Bowie
+1 (914) 847-3407
Alexandra.bowie@regeneron.com
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