European Commission to review and make a final
decision, expected late May
2023
PLYMOUTH
MEETING, Pa., April 26,
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 Committee for Orphan Medicinal Products (COMP) has
provided a positive opinion on INOVIO's application for orphan drug
designation in the European Union (EU) for INO-3107. INO-3107 is
the company's product candidate that may contribute to the
treatment of Recurrent Respiratory Papillomatosis (RRP). The
opinion is now with the European Commission, which will provide a
final decision on the application within 30 days.
Orphan designation is for medicines in development for the
diagnosis, prevention or treatment of rare diseases that are
life-threatening or very serious. The Orphan Medicinal Products
Regulation (Regulation (EC) No 141/2000) defines an orphan
medicinal product as one intended for diseases affecting fewer than
5 in 10,000 people across the EU.
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 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, 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.