PLYMOUTH
MEETING, Pa., May 23, 2023
/PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company
focused on developing and commercializing DNA medicines
to help treat and protect people from HPV-related diseases,
cancer, and infectious diseases, today announced that the
European Commission (EC) has granted orphan drug designation for
INO-3107, the company's product candidate for the treatment of
Recurrent Respiratory Papillomatosis (RRP). INO-3107 is an
investigational DNA medicine candidate designed to elicit a
targeted T cell response against HPV-6 and HPV-11, the HPV types
that cause RRP and other HPV-related diseases.
INOVIO previously announced that the European Committee for
Orphan Medicinal Products (COMP) had provided a positive opinion on
INOVIO's application for orphan drug designation in the European
Union (EU) for INO-3107. The adoption of this decision by the EC
formalizes INO-3107 as a designated orphan drug in the EU. INO-3107
received orphan drug designation from the U.S. Food and Drug
Administration (FDA) in July 2020,
making it the first RRP product candidate to receive designations
from both U.S. and EU regulatory bodies.
"By granting orphan drug designation, U.S. and EU regulators are
acknowledging the high unmet medical need of those suffering from
this debilitating disease," said INOVIO's Senior Vice President of
Regulatory Affairs, Dr. Cheryl
Elder. "This is yet another important step forward for our
development process and for the RRP patients around the world who
could benefit from a potentially game-changing therapy."
Orphan drug designation is granted for the treatment,
prevention, or diagnosis of diseases that are life-threatening or
chronically debilitating and affect no more than five in 10,000
people across the European Union (EU). Medicines that are granted
orphan drug designation by the EC qualify for financial and
regulatory incentives including protocol assistance at reduced
charges, access to centralized marketing authorization, and up to
10 years of market exclusivity in the EU after product
approval.
About RRP
RRP is a debilitating and rare disease caused primarily by HPV-6
and/or HPV-11. RRP is characterized by the development of small,
wart-like growths, or papillomas, in the respiratory tract. While
papillomas are generally benign, they can cause severe,
life-threatening airway obstruction and respiratory complications.
RRP can also significantly affect quality of life for patients by
affecting the voice box, limiting the ability to speak effectively.
Surgery to remove papillomas is the standard of care for RRP;
however, the papillomas often grow back because the underlying HPV
infection has not been eradicated.
About INO-3107
INO-3107 is INOVIO's clinical-stage DNA medicine product
candidate being developed as a potential treatment for RRP.
INO-3107 is designed to elicit a targeted T cell response against
HPV-6 and HPV-11, the HPV types responsible for causing RRP among
other HPV-related diseases. These targeted T cells are designed to
seek out and kill infected cells, with the aim of potentially
preventing or slowing the growth of new papillomas.
INO-3107 received orphan drug designation from the U.S.
Food and Drug Administration (FDA) in July
2020. For more information about INOVIO's HPV franchise,
please
visit https://ir.inovio.com/events-and-presentations/default.aspx
About INOVIO
INOVIO is a biotechnology company focused on developing and
commercializing DNA medicines to help treat and protect people from
HPV-related diseases, cancer, and infectious diseases. INOVIO's DNA
medicines in development are delivered using its investigational
proprietary smart device, CELLECTRA®, to produce immune
responses against targeted pathogens and cancers. For more
information, visit www.inovio.com.
Contacts
Media: Jennie Willson (267)
429-8567 jennie.willson@inovio.com
Investors: Thomas Hong (267)
440-4298 thomas.hong@inovio.com
Forward-Looking Statements
This press release contains certain forward-looking statements
relating to our business, including our plans to develop and
commercialize DNA medicines and 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, 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, product development programs and commercialization
activities and outcomes, 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 medicines, our ability to support our pipeline
of DNA medicine 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 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, 2022, our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2023, and other filings we make from
time to time with the Securities and Exchange Commission. There can
be no assurance that any product candidate in our pipeline will be
successfully developed, manufactured, or commercialized, that the
results of clinical trials will be supportive of regulatory
approvals required to market 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.
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SOURCE INOVIO Pharmaceuticals, Inc.