- Company will request Rolling Submission and Priority Review
of its Biological License Application (BLA) by U.S. Food and Drug
Administration (FDA) to expedite review process
- Accelerating commercialization efforts to be prepared to
launch INO-3107 in 2025
PLYMOUTH
MEETING, Pa., Jan. 3, 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 plans to submit a
BLA for INO-3107 as a potential treatment for Recurrent Respiratory
Papillomatosis (RRP) in the second half of 2024. This announcement
follows an Initial Comprehensive Multidisciplinary Breakthrough
Therapy (Type B) Meeting with the FDA on critical aspects of the
data package required to submit a BLA under the agency's
accelerated approval program.
"Based on productive discussions with the FDA, we believe we now
have established a path to submitting a BLA for INO-3107 under the
accelerated approval program," said Dr. Jacqueline Shea, INOVIO's President & Chief
Executive Officer. "Our plan is to complete the submission of our
BLA in the second half of 2024 and request a Priority Review. We
also plan to initiate a confirmatory trial prior to submission of
our BLA. Concurrently, we will continue advancing our commercial
plans, with the goal of being ready to launch INO-3107 in
2025."
A Priority Review, if granted, could shorten the FDA's review of
the BLA to approximately six months from the time of the
submission being accepted, as compared to a standard review
timeline of approximately 10 months. If approved, INO-3107 would be
the first DNA medicine made available to RRP patients in
the United States and INOVIO's
first approved product. The FDA previously 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 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.
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 could 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.
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 CELLECTRA® delivery devices help ensure its DNA
medicines enter the body's cells for optimal effect, without
chemical adjuvants or nanoparticles and
without the risk of the anti-vector response seen in 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.
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
INOVIO's business, including its plans to develop and
commercialize DNA medicines and its expectations regarding its
research and development programs, including plans to submit
a BLA for priority review and to initiate a
confirmatory trial for INO-3107, and expectations with respect to
the commercialization of INO-3107 if it is approved by regulatory
authorities. 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, INOVIO's
ability to support its pipeline of DNA medicine products, the
ability of INOVIO's collaborators to attain
development and commercial milestones for products INOVIO
licenses and product sales that will enable INOVIO
to receive future payments and royalties, the adequacy
of INOVIO's capital resources, the availability or
potential availability of alternative therapies or treatments for
the conditions targeted by INOVIO or its
collaborators, including alternatives that may be more efficacious
or cost effective than any therapy or treatment that INOVIO
and its collaborators hope to develop, issues involving
product liability, issues involving patents and whether they or
licenses to them will provide INOVIO 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 INOVIO
can finance or devote other significant resources that may be
necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of INOVIO's
technology by potential corporate or other partners or
collaborators, capital market conditions, the impact of government
healthcare proposals and other factors set forth in INOVIO's
Annual Report on Form 10-K for the year ended December 31, 2022, its Quarterly Report on Form
10-Q for the quarter ended September 30,
2023, and other filings INOVIO makes from time
to time with the Securities and Exchange Commission. There can be
no assurance that INO-3107 or any other product candidate in
INOVIO's 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 INOVIO
undertakes no obligation to update or revise these
statements, except as may be required by law.
View original
content:https://www.prnewswire.com/news-releases/inovio-plans-to-submit-a-bla-for-ino-3107-as-a-potential-treatment-for-rrp-in-second-half-of-2024-under-accelerated-approval-program-302025051.html
SOURCE INOVIO Pharmaceuticals, Inc.