- Treatment with INO-3107 resulted in 16 of 21 (76%) participants
with a reduction in number of surgical interventions compared with
previous year; 6 participants required no surgical intervention
during the trial
- INO-3107 demonstrated statistical significance based on
clinical endpoint of reduction in overall number of surgical
interventions compared with previous year
- INO-3107 was found to be well-tolerated and immunogenic
PLYMOUTH
MEETING, Pa., Oct. 13,
2022 /PRNewswire/ -- INOVIO (NASDAQ:INO), a
biotechnology company focused on developing and commercializing DNA
medicines to help treat and prevent infectious diseases, cancer,
and diseases associated with HPV, today announced positive interim
results from an ongoing Phase 1/2 clinical trial evaluating
INO-3107 for the treatment of HPV 6 and HPV 11-associated Recurrent
Respiratory Papillomatosis (RRP) in adults. In the first cohort of
21 participants, INO-3107 showed a statistically significant
improvement in the clinical endpoint of the number of surgical
interventions needed to control papilloma growth. INO-3107 was also
observed to be well-tolerated and immunogenic in the trial.
INO-3107 received Orphan Drug Designation from the
U.S. Food and Drug Administration (FDA) in July 2020.
Dr. Jacqueline Shea, INOVIO's
President and CEO, said, "RRP is a debilitating, often life-long
condition for which surgery is the standard of care and there are
no currently FDA-approved therapeutic vaccines or drugs. The
positive results observed in this trial are a step toward
potentially shifting the treatment paradigm for RRP and
substantially improving the quality of life for patients suffering
from its symptoms and the repeated surgeries needed to control
them. As a potential first-in-class therapeutic candidate, INO-3107
is building on our body of work indicating that DNA medicines have
the potential to treat HPV-associated diseases."
Dr. Ted Mau, Professor of
Otolaryngology, Head and Neck Surgery at UT Southwestern Medical
Center and investigator for INOVIO's RRP Phase 1/2 clinical trial,
said, "These preliminary results show great promise in this new
therapy for patients with RRP. For our patients who have required
multiple surgeries a year, and especially those who have done so
for many years of their lives, this is a potential
game changer."
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 participants with HPV 6 and/or HPV 11-associated RRP
(NCT:04398433). The trial demonstrated statistical
significance based on the clinical endpoint of a reduction in
the number of RRP surgical interventions in the year following
administration of INO-3107 compared with the year prior to
treatment, in the initial cohort of 21 participants. In the
trial, there was a median decrease of 3 surgical interventions
(95% confidence interval 1, 3). In addition, 16 of 21 (76%)
participants showed a decrease in surgical interventions in the
year following administration of INO-3107 relative to the number of
surgeries in the year prior to the trial. Of the 16
participants, six (6) required no surgical intervention during the
trial period.
In the trial, treatment with INO-3107 induced cellular responses
against both HPV 6 and HPV 11, inducing both CD4 and CD8 T cells.
All 21 participants demonstrated an increase in peripheral T
cells to one or more antigens in INO-3107 post-baseline. T-cell
responses against HPV 6 and HPV 11 were also still observed at Week
52, which was 43 weeks after treatment with INO-3107, indicating a
persistent cellular memory response.
INO-3107 was well-tolerated, with all participants completing
the trial follow-up. Treatment-emergent adverse events (TEAEs)
observed in the trial were generally low-grade, with 86% of
participants experiencing at least one TEAE, most of which were
Grade 1. Three participants (14%) experienced a Grade 3 TEAE, but
none were deemed related to INO-3107. The most commonly reported
TEAEs were injection site pain (38%) and fatigue (19%). While
two serious adverse events were reported, these were also
deemed unrelated to INO-3107.
Dr. Jeffrey Skolnik, INOVIO's
Senior Vice President of Clinical Development, said, "We are very
encouraged by the results of the Phase 1/2 trial, where we observed
a median reduction of three surgical interventions from the year
prior, with six participants being surgery-free, after receiving
treatment with INO-3107 during the trial. We believe the ability of
INO-3107 to induce antigen-specific immune responses may play an
important role in the future treatment of RRP."
Results from the second cohort of 11 patients are expected in
the first half of 2023.
About RRP
RRP is a debilitating and rare disease caused primarily by HPV
types 6 and/or 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 voicebox, limiting the ability to speak effectively.
In RRP, the papillomas have a tendency to grow back after they have
been removed surgically, which is the current standard of care,
because the underlying HPV infection is not eradicated.
The incidence of RRP is rapidly changing, but has previously
been estimated to be 4.3 per 100,000 children and 1.8 per 100,000
adults. RRP is often a life-long disease that affects both children
and adults. Patients may undergo numerous surgeries during their
lifetimes to control their RRP.
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-associated diseases. These targeted T cells seek out and
kill infected cells, leading potentially to a regression of
existing papillomas and the possibility of clearing or reducing the
levels of the virus which could prevent or slow the growth of new
papillomas. The U.S. FDA granted Orphan Drug Designation for
INO-3107 for the treatment of RRP in 2020. For more information
about our HPV franchise, please visit
https://ir.inovio.com/investors-and-media/default.aspx.
About INOVIO
INOVIO is a biotechnology company focused on developing and
commercializing DNA medicines to help treat and protect people from
infectious diseases, cancer, and diseases associated with HPV. Our
DNA medicines in development are delivered using our
investigational proprietary smart device to produce immune
responses against targeted pathogens and cancers. For more
information, visit www.inovio.com.
Contacts
Investors & Media:
Gene Kim, (267) 589-9471,
gene.kim@inovio.com
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 availability and
timing of data from clinical 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, 2021, our
Quarterly Report on Form 10-Q for the quarter ended June 30, 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.