TARRYTOWN, N.Y. and
PLYMOUTH MEETING, Pa.,
May 8, 2017 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Inovio Pharmaceuticals,
Inc. (NASDAQ: INO) 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.
"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."
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.
"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."
"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," said J. Joseph Kim, PhD, Inovio's President and Chief
Executive Officer. "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."
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 Regeneron, 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.
Regeneron Forward-Looking Statements and Use of Digital
Media
This 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).
Inovio Forward-Looking Statements
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 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
Contacts:
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Media
Relations
Alexandra
Bowie
Tel.: +1 (914)
847-3407
alexandra.bowie@regeneron.com
|
Investor
Relations
Manisha Narasimhan,
Ph.D.
Tel.: +1 (914)
847-5126
manisha.narasimhan@regeneron.com
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Inovio
Contacts:
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Media
Relations
Jeff
Richardson
Tel.: +1 (267)
440-4211
jrichardson@inovio.com
|
Investor
Relations
Bernie
Hertel
Tel.: +1 (858)
410-3101
bhertel@inovio.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.