- American Association for Cancer Research (AACR) Special
Conference: Tumor Immunology and Immunotherapy: New
immunology data showed ability of INO-3107 to induce an
antigen-specific T cell response against HPV-6 and HPV-11 and drive
recruitment of T cells into airway tissues and papilloma
- International Society of Vaccines Conference:
Full safety and efficacy data from Phase 1/2 clinical study in
patients with Recurrent Respiratory Papillomatosis (RRP) indicated
that INO-3107 was well tolerated and immunogenic; 81% of patients
in the trial required fewer surgeries post-treatment when compared
to baseline
PLYMOUTH
MEETING, Pa., Oct. 21,
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 the
presentation of new data at scientific conferences for its lead
candidate, INO-3107, for which the company is preparing a Biologics
License Application for targeted submission in mid-2025 under the
U.S. Food and Drug Administration's Accelerated Approval Pathway
Program.
At AACR's Tumor and Immunology Conference on
October 19, INOVIO presented new
immunology data demonstrating the ability of INO-3107 to induce
antigen-specific T cell responses against HPV-6 and HPV-11 and
drive recruitment of those T cells into airway tissues and
papilloma of RRP patients, which could ultimately slow or eliminate
papilloma regrowth. Additionally, INOVIO will tomorrow present its
full safety and efficacy data set for the Phase 1/2 trial for
INO-3107 at the International Society of Vaccines
Conference. In the trial, INO-3107 was found to be well
tolerated and immunogenic. Of the 32 patients in the trial, 26
patients, or 81%, experienced a decrease in the number of surgical
interventions in the year after treatment when compared to the year
before treatment.
"The new immunology data support the proposed mechanism of
action of INO-3107 which is to generate an immune response that can
seek out and eliminate HPV-6 and HPV-11 infected cells that are the
underlying cause of papilloma growth," said Dr. Matthew Morrow, INOVIO's Vice President of
Translational Science. "Our analysis shows that INO-3107
induced significant clonal T cell expansion in the blood, including
antigen-specific killer T cells. Investigators also observed T cell
infiltration into airway tissue, which is positively associated
with clinical response."
"The collective story these data sets provide is compelling.
Over 81% of patients who received INO-3107 required fewer surgical
procedures compared to baseline, a result that is further supported
by the new immunology data demonstrating the ability of INO-3107 to
stimulate the immune system and generate antigen-specific T cells
that travel to the airways and could eliminate the underlying
disease," said Dr. Jacqueline Shea,
INOVIO's President and Chief Executive Officer. "We believe these
data continue to demonstrate that INO-3107 has the potential to
significantly improve the lives of patients living with RRP and
become the preferred choice for the broadest number of RRP patients
and healthcare providers."
Summary of Data Presented at Conferences
AACR Special Conference in Cancer Research: Tumor Immunology
and Immunotherapy
Abstract: Reduction in
Surgical Interventions for the Treatment of Recurrent Respiratory
Papillomatosis by INO-3107 is Associated with Enriched Macrophage,
Dendritic cell and T cell Signatures in Patient Airways
New Immunology data for INO-3107 demonstrated:
- Induction of T cell responses specifically for HPV-6 and
HPV-11
- Expansion of antigen specific, clonal T cell populations in
peripheral blood
- Induction of inflammatory responses in papilloma and airway
tissue, including:
- Interferon, cytokine and chemokine signaling
- Adaptive and innate immune cell infiltration, with emphasis on
T cells
- Cytotoxic signatures of infiltrated T cells in papilloma/airway
tissue, providing direct evidence of increased overall T cell
infiltration compared to pre-treatment
- Clinical activity not impacted by immunosuppressive
papilloma microenvironment
International Society of Vaccines
Conference
Abstract: Clinical Assessment of
Adjuvant Immunotherapy, INO-3107, in Adult Patients with Recurrent
respiratory papillomatosis (RRP)
Clinical Results of Phase 1/2 Study with INO-3107 in Adult RRP
Patients
In the trial, the overall clinical response (OCR) was 81%, with 26
of the 32 enrolled patients experiencing a decrease in the number
of surgical interventions in the year after INO-3107 administration
compared to the prior year, including 28% (9/32) that required no
surgical intervention (i.e., complete response or "CR") during or
after the dosing window. Further, 44% (14/32) of patients had a
partial response ("PR"), measured by a reduction of at least 50%,
but less than 100%, in the number of surgeries when compared to the
prior year. The overall response rate (ORR) of patients (CR+PR) was
therefore 72% (23/32).
Other key data points presented include:
- INO-3107 was well tolerated and immunogenic in the 32 patients
enrolled
- 41% (13/32) of patients reported a treatment-related Adverse
Event (AE)
- Most frequent treatment-related AE's reported were injection
site pain (31%) and fatigue (9%)
- No treatment-related AEs greater than Grade 2 severity were
reported
- Modified Derkay-Pransky severity scores improved from baseline
to the end of 52-week trial
- INO-3107 induced durable cellular responses and generated T
cells against HPV-6 and HPV-11
The abstracts from the poster and presentations are available on
the INOVIO events page: [tbd link]
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 INO-3107
INO-3107 is a DNA immunotherapy
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 trial (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 demonstrated 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 is expected to 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
granted INO-3107 Orphan Drug designation and assigned INOVIO's
delivery device CELLECTRA® a CE marking, a regulatory standard
that certifies that a product has met European Union's safety,
health, and environmental standards. The United Kingdom awarded INO-3107 the Innovation
Passport. This designation serves as the entry point to the
Innovative Licensing and Access Pathway (ILAP), which aims to
accelerate time to market and facilitate patient access to
medicines.
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.
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.
