Data reviewed complies with standards that
would be used to evaluate an EU Marketing Authorization
Application
PLYMOUTH
MEETING, Pa., July 25,
2024 /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 Medicines Agency's Committee for Advanced
Therapies (CAT) has certified the quality and non-clinical data for
INO-3107, INOVIO's lead candidate for the treatment of
Recurrent Respiratory Papillomatosis (RRP). The certification
confirms that INOVIO's chemistry, manufacturing and controls (CMC)
data and nonclinical results available to date comply with the
scientific and technical standards that would be used for
evaluating a European Marketing Authorization Application.
"This latest regulatory achievement further validates our
efforts to bring INO-3107 to RRP patients around the world and
shows that our cross functional development team is meeting the
highest of standards in pursuit of that goal," said
Cheryl Elder, INOVIO's Senior Vice
President of Regulatory Affairs. "We're pleased to receive
confirmation that our development efforts in Europe continue to make progress."
The CAT provides assessment and certification of advanced
therapy medicinal products (ATMPs) under development by micro-,
small- and medium-sized enterprises (SMEs), providing an important
opportunity to identify any potential development issues prior to
the submission of a Marketing Authorization Application.
About INO-3107
INO-3107 is designed to elicit an antigen-specific T cell
response against both HPV-6 and HPV-11 proteins. These targeted T
cells are designed to seek out and kill HPV-6 and HPV-11 infected
cells, with the aim of potentially preventing or slowing the growth
of new papillomas. In a Phase 1/2 clinical trial conducted with
INO-3107, 81.3% (26/32) of patients had a decrease in surgical
interventions in the year after INO-3107 administration compared to
the prior year, including 28.1% (9/32) that required no surgical
intervention during or after the dosing window. Patients in the
trial had a median range of 4 surgeries (2-8) in the year prior to
dosing. After dosing, there was a median decrease of 3 surgical
interventions (95% confidence interval -3, -2). At the outset of
the trial (Day 0), patients had a clinically warranted procedure to
have RRP tissue surgically removed, but any surgery performed after
Day 0 during the dosing window was counted against the efficacy
endpoint. Treatment with INO-3107 generated a strong immune
response in the trial, inducing activated CD4 T cells and activated
CD8 T cells with lytic potential. T-cell responses were also
observed at Week 52, indicating a persistent cellular memory
response. INO-3107 was well tolerated by participants in the trial,
resulting in mostly low-grade (Grade 1) treatment-emergent adverse
effects such as injection site pain and fatigue. Like other DNA
medicines, INO-3107 has demontrated the ability to generate
antigen-specific T cells that is not affected by anti-vector
immunity impacting immunogenicity, either before administration or
after the first dose unlike other T-cell generating platforms such
as viral vectors. This feature of DNA medicines is expected to
allow INO-3107 to maintain T cell response and overall efficacy,
which would make it an important therapeutic option for a majority
of RRP patients.
The FDA granted INO-3107 Orphan Drug designation and
Breakthrough Therapy designation, and advised INOVIO that it could
submit its BLA under the accelerated approval program using data
from its already completed Phase 1/2 trial. The European Commission
granted INO-3107 Orphan Drug designation and assigned INOVIO's
delivery device CELLECTRA® a CE marking, a regulatory standard that
certifies that a product has met European Union's safety, health,
and environmental standards. The United
Kingdom awarded INO-3107 the Innovation Passport. This
designation serves as the entry point to the Innovative Licensing
and Access Pathway (ILAP), which aims to accelerate time to market
and facilitate patient access to medicines.
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. INOVIO's market research
to date with patients and healthcare professionals indicates that a
reduction of even one surgery matters, because every surgery poses
a significant risk of causing permanent damage to the vocal cords.
The most widely cited U.S. epidemiology data published in 1995
estimated that there were 14,000 active cases and about 1.8 per
100,000 new cases in adults each year.
About INOVIO's DNA Medicines Platform
INOVIO's DNA medicines platform has two innovative components:
precisely designed DNA plasmids, delivered by INOVIO's proprietary
investigational medical device, CELLECTRA®. INOVIO uses proprietary
technology to design its DNA plasmids, which are small circular DNA
molecules that work like software the body's cells can download to
produce specific proteins to target and fight disease. INOVIO's
proprietary CELLECTRA® delivery devices are designed to optimally
deliver its DNA medicines to the body's cells without requiring
chemical adjuvants or lipid nanoparticles and without the risk of
the anti-vector response historically seen with viral vector
platforms.
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
technology optimizes the design and delivery of innovative DNA
medicines that teach the body to manufacture its own
disease-fighting tools. For more information, visit
www.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 expectations regarding our research
and development programs, including timelines and prospects for
regulatory approval, expectations regarding INO-3107's ability to
maintain T cell response and overall efficacy, as well as
benefits for patients. 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, 2023, our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2024, 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.
Contacts
Media: Jennie
Willson, (267) 429-8567, jennie.willson@inovio.com
Investors: Thomas Hong, (267)
440-4298, thomas.hong@inovio.com
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SOURCE INOVIO Pharmaceuticals, Inc.