Award recognizes the potential for INO-3107 to
be the first therapeutic option in the United Kingdom for patients suffering from
Recurrent Respiratory Papillomatosis (RRP)
PLYMOUTH
MEETING, Pa., July 11,
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 its
lead DNA medicine candidate, INO-3107, has been designated an
innovative medicine as part of the U.K.'s Innovative Licensing and
Access Pathway (ILAP). The designation, called an Innovation
Passport, was granted by the ILAP Steering Group to INO-3107 for
the treatment of patients with Recurrent Respiratory Papillomatosis
(RRP), a debilitating, chronic rare disease of the respiratory
tract caused by HPV-6 and/or HPV-11.
"The U.K. Innovation Passport designation is yet another
recognition of the promise of INO-3107 to potentially transform the
treatment paradigm for RRP patients," said Dr. Jacqueline Shea, INOVIO's President and Chief
Executive Officer. "We are honored to receive this designation,
which offers us enhanced access to regulators and development tools
that could accelerate the timeline for achieving U.K. regulatory
approval of INO-3107. We look forward to continuing our discussions
with the ILAP partners as we work to deliver this promising DNA
medicine to patients as quickly as possible."
The Innovation Passport is the entry point to the ILAP, which
aims to accelerate time to market and facilitate patient access to
medicines in the United Kingdom.
The Innovation Passport provides a single, streamlined roadmap for
regulatory approval and development milestones. Recipients of the
Innovation Passport are granted access to a range of development
tools to support the design, development and approvals process in
the U.K., as well as opportunities for enhanced regulatory and
other stakeholder input. Specific benefits of ILAP include the
potential for a 150-day accelerated Marketing Authorization
Application (MAA) assessment, rolling review and a continuous
benefit risk assessment. The ILAP is delivered in partnership by
the U.K. Medicines and Healthcare products Regulatory Agency
(MHRA), the All Wales Therapeutics and Toxicology Centre, the
National Institute for Health and Care Excellence and the Scottish
Medicines Consortium, part of Healthcare Improvement Scotland. The
MHRA launched ILAP at the start of 2021 to accelerate the
development and access to promising medicines in the early stages
of development. The pathway is part of the UK's plan to attract
life sciences development in the post-Brexit era. For more
information about the Innovation Passport and ILAP, visit:
Innovative Licensing and Access Pathway - GOV.UK
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 study (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 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 should 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
has also granted INO-3107 Orphan Drug designation. INOVIO's
delivery device, CELLECTRA®, received CE marking, a regulatory
standard that certifies that a product has met European Union's
safety, health, and environmental standards.
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, 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.