- Oral presentation provided new combined safety and
immunogenicity data from both cohorts (standard and
side-port needles)
- Data indicates INO-3107 was well tolerated and has the
potential to provide clinical benefit to adults with RRP
PLYMOUTH
MEETING, Pa., May 8, 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, presented new data from a Phase
1/2 trial of INO-3107 (NCT:04398433) for the treatment of HPV 6 and
HPV 11-associated Recurrent Respiratory Papillomatosis (RRP) on
May 5th as part of the
scientific program of the American Broncho-Esophagological
Association (ABEA) at the Combined Otolaryngology Spring Meetings
(COSM) in Boston, Massachusetts.
The COSM is a major national meeting of otolaryngologists/head and
neck surgeons and incorporates the scientific programs of eight
participating professional societies including the ABEA.
Dr. Ted Mau, lead investigator
and laryngologist at University of Texas
Southwestern Medical Center, presented the new data during
an oral presentation at the conference.
"The additional data on INO-3107 presented demonstrate
immunogenicity and potential for efficacy," said Dr. Mau. "INO-3107
reduced the need for surgical interventions for most trial
participants – arguably the most important potential clinical
benefit to patients living with this disease."
Dr. Jeffrey Skolnik, INOVIO's
Senior Vice President of Clinical Development added: "The data set
we've analyzed from this trial indicate that INO-3107 could
potentially provide a life-changing alternative to the current
standard of care for RRP. We are focused on moving this candidate
forward as quickly as possible to realize its potential for
patients globally."
In February 2023, INOVIO announced
positive preliminary results from the second (side port needle)
cohort of its Phase 1/2 clinical trial evaluating INO-3107 for the
treatment of HPV 6 and HPV 11-associated RRP in adults. Positive
results from the first (standard needle) cohort were shared in
October 2022. At COSM, Dr. Mau
presented combined safety and immunogenicity data from both
cohorts.
Safety highlights:
- INO-3107 was well-tolerated, with the most frequently reported
treatment-emergent adverse events (TEAEs) related to
administration, and all related TEAEs were low-grade
- Most commonly reported TEAEs: injection site pain (31%),
fatigue (16%), and headache (13%)
- No treatment-related SAEs and no TEAEs led to treatment
discontinuation
Immunological data highlights:
- Treatment with INO-3107 induced cellular responses against both
HPV 6 and HPV 11, inducing both CD4+ and CD8+ T cells, including
cytotoxic CD8 cells thought to be important for clearance of
virally infected cell
- All 32 participants demonstrated an increase in at least one
peripheral T cell assessment to one or more antigens in INO-3107
above levels prior to treatment
- T-cell responses against HPV 6 and HPV 11 were still observed
at Week 52, which was 43 weeks after treatment with INO-3107,
indicating persistent cellular memory response
- Additional analysis is ongoing to determine possible
relationships between CD4+ and CD8+ T cell phenotypes and clinical
outcome
Overall, 81.3% (26/32) patients had a decrease in surgical
interventions in the year after INO-3107 administration versus the
prior year, including 28.1% (9/32) that required no surgical
intervention. Patients 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). In
the trial, 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.
The data presented at ABEA were also included in a peer-reviewed
manuscript accepted for publication by 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, in publication since 1896, is the official
journal of the Triological Society (TRIO), the American
Laryngological Association (ALA), and the ABEA.
About the Trial
INO-3107 was evaluated in a Phase 1/2 open-label, multicenter
trial to assess its safety, tolerability, immunogenicity, and
efficacy in 32 patients with HPV 6 and/or HPV 11-associated RRP
(NCT:04398433). The first cohort included 21 patients - the second
included 11. In the first cohort, patients were dosed with a
standard needle, while in the second, an exploratory side port
needle was used to deliver INO-3107. INOVIO plans to use the
standard needle in the next trial involving INO-3107. In both
cohorts, the proprietary CELLECTRA® electroporation device was
used. The trial evaluated the reduction in the number of surgical
interventions in the year following initial administration of
INO-3107 compared to the year prior to treatment.
In both cohorts, 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. Per protocol, a surgical intervention was
defined as any removal of papilloma tissues, whether in hospital or
in the clinic, using either general or local anesthesia, with any
modality of removal.
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 from 1995 cites
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 US 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 U.S. Food and Drug
Administration (FDA) in July 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 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.