• Designation based on clinical evidence
indicating INO-3107 may demonstrate substantial improvement over
existing therapies
• First Breakthrough Therapy designation for
an INOVIO DNA medicine candidate
PLYMOUTH
MEETING, Pa., Sept. 7,
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 U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy designation for INO-3107 as a
potential treatment for patients with Recurrent Respiratory
Papillomatosis (RRP). The FDA's Breakthrough Therapy designation is
a process designed to expedite the development and review of drug
candidates that are intended to treat a serious or life-threatening
condition and for which preliminary clinical evidence indicates
that the drug may demonstrate substantial improvement over
available therapy on a clinically significant endpoint(s).
"This is yet another important step for INO-3107 and recognition
that this first-in-class DNA medicine candidate has the potential
to improve the lives of patients with RRP," said INOVIO's President
and Chief Executive Officer, Dr. Jacqueline
Shea. "As we recently announced, we have been interacting
with the FDA with the goal to launch a pivotal trial for INO-3107
in the near term. With this Breakthrough Therapy designation, we
look forward to continuing to work with the agency so that we can
generate the evidence needed to support approval of INO-3107 as
quickly and efficiently as possible, with an ultimate aim to help
RRP patients and deliver on the promise of DNA medicine."
The President of the Recurrent Respiratory Papillomatosis
Foundation, Kim McClellan, said:
"RRP patients will tell you that even one reduction in the number
of disruptive, invasive surgeries they face would be life-changing.
The potential impact of this treatment gives me great hope for the
future and I'm happy to see that RRP is finally getting the
attention it deserves."
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 disease. This
Breakthrough Therapy designation for INO-3107 follows receipt of
Orphan Drug designation from the European Commission in
May 2023 and from the FDA in
2020.
INOVIO plans to initiate a pivotal trial of INO-3107 in the
first quarter of 2024, subject to FDA clearance. As part of its
development efforts, the company has engaged a leading Clinical
Research Organization to help run the pivotal trial, as well as key
opinion leaders and investigators interested in developing a new
treatment option for RRP patients.
The Breakthrough Therapy designation is supported by data from
INOVIO's completed Phase 1/2 open-label, multicenter trial that
assessed INO-3107's safety, tolerability, immunogenicity, and
efficacy in patients with HPV-6 and/or HPV-11-related RRP
(NCT:04398433). Overall, 81.3% (26/32) patients in the trial 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). Patients received four doses of INO-3107 on Day 0, and Weeks
3, 6, and 9. At the outset of the study (Day 0), patients could
have RRP tissue surgically removed, but any surgery performed after
Day 0 during the dosing window was counted against the efficacy
endpoint. INO-3107 was well-tolerated by participants in the
trial.
Data from this Phase 1/2 trial has been presented at scientific
and medical conferences, including the 2023 Annual Meeting of the
American Broncho-Esophageal Association (ABEA) in May and at the
European Laryngological Association's Annual Meeting in June. Data
from the trial was also published in May in the peer-reviewed
journal, The Laryngoscope, under the title "Interim Results
of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or
HPV-11–Associated RRP." The Laryngoscope is the official
journal of the Triological Society (TRIO), the American
Laryngological Association (ALA), and the ABEA.
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.
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. More recent pediatric
epidemiology data cites a range of 0.5 - 0.7 per 100,000 new cases
in children in the U.S. each year.
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
European Commission in May 2023 and
from the U.S. Food and Drug Administration in 2020. For more
information about our 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 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 June 30, 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.