PLYMOUTH
MEETING, Pa., Jan. 9, 2025
/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 highlighted anticipated milestones for
2025 and key accomplishments from 2024 in advance of upcoming
investor meetings.
"Based on the progress achieved in 2024, we anticipate 2025 to
be a transformational year for INOVIO as we move closer to our goal
of becoming a commercial-stage company providing a breakthrough
therapy for patients suffering from a devastating rare disease and
delivering on the promise of DNA medicines," said Dr. Jacqueline Shea, INOVIO's President and Chief
Executive Officer. "Our top priorities for the coming year are the
submission of our biologics license application (BLA) for INO-3107
and preparing to expedite the launch of the product commercially,
should it be approved. We also look forward to making progress with
our pipeline through collaborations and other potential strategic
opportunities."
INO-3107
Anticipated Milestones for 2025
- Submit BLA to the U.S. Food and Drug Administration (FDA) by
mid-2025 and request priority review. INO-3107 could be the
preferred non-surgical therapeutic option for recurrent respiratory
papillomatosis (RRP) and would be the first DNA medicine approved
for any indication in the United
States, should it be approved.
- Resolution of previously announced single-use array
manufacturing issue expected by February
2025. Next steps following resolution include completion of
retesting process for the CELLECTRA® device and finalization of the
device sections of the Chemistry, Manufacturing and Controls (CMC)
module, which will be used to update the active Investigational New
Drug (IND) Application for the confirmatory trial as well as the
BLA submission.
- Initiate confirmatory trial.
- Trial will be conducted at approximately 20 leading U.S.
academic centers, enrolling approximately 100 patients randomized
to receive either INO-3107 or placebo on a 2:1 basis. With eligible
patients having a history of two or more surgeries per year to
treat their RRP, this trial is intended to evaluate a population
that is highly representative of the broad spectrum of RRP
disease.
- INOVIO believes that the design of the confirmatory trial could
also support expansion into global markets based on feedback
received to date from European and UK regulators.
- Submit a redosing study protocol to the FDA.
- Recently announced durability data support rationale for
redosing patients with goal to maintain or improve clinical
benefit.
- Present and publish recently announced durability data and
immunology data, as well as the full efficacy and tolerability data
from completed Phase 1/2 clinical trial, in a peer-reviewed
scientific journal.
Key 2024 Accomplishments
- Reported data from a retrospective trial showing that half of
RRP patients treated with INO-3107 achieved a complete response
(CR) and required no surgery when evaluated at the end of year two
and into year three after the initial Phase 1/2 trial, increasing
from the initial CR rate of 28% at the end of the first year.
- The retrospective analysis showed that of those patients who
had an initial CR, 88% maintained their CR by end of the second
year and 63% into the third year.
- 95% of patients maintained or enhanced their original Overall
Response Rate ("ORR," defined as those patients who achieved either
a CR or a partial response) after two years, while 86% of patients
maintained or enhanced their ORR into year three.
- 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 potentially slow
or eliminate papilloma regrowth.
- Presented the full safety and efficacy data set for the Phase
1/2 trial in which administration of INO-3107 was shown to be well
tolerated and resulted in clinical benefit.
- No treatment-related serious adverse events among patients in
the trial, and all treatment-related adverse events (AEs) were
Grade 1 or Grade 2. The most commonly reported AEs were injection
site pain (31%) and fatigue (9%). There were no patients who
discontinued treatment during the trial.
- 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 European Medicines Agency's Committee for Advanced
Therapies (CAT) certified the quality and non-clinical data for
INO-3107, confirming that CMC data and nonclinical results
available to date comply with the scientific and technical
standards to be used in evaluating a potential European Marketing
Authorization Application.
- INO-3107 was designated an innovative medicine as part of the
U.K.'s Innovative Licensing and Access Pathway (ILAP).
- Progressed commercial readiness plans to be launch ready by the
end of 2025, including: refining go-to-market strategy focused on
patient and physician needs; driving key strategic decisions on
pricing and access, product distribution, targeting and
segmentation, and product positioning; and developing plans for the
build out of the commercial organization.
INO-3112
Anticipated Milestones for 2025 and Key 2024 Accomplishments
- Gain alignment on planned Phase 3 trial design with European
Union regulators
- Trial to be conducted in North
America and Europe through
a clinical collaboration and supply agreement signed in 2024 with
Coherus BioSciences, Inc., evaluating the combination of INO-3112
and LOQTORZI® (toripalimab-tpzi) in patients with locoregionally
advanced, high-risk, HPV16/18-positive oropharyngeal squamous cell
carcinoma (OPSCC). LOQTORZI is a PD-1 inhibitor approved by the FDA
and European Commission for the treatment of recurrent locally
advanced/metastatic nasopharyngeal carcinoma (R/P NPC). The
European Commission also approved LOQTORZI for the treatment of
unresectable advanced, recurrent, or metastatic esophageal squamous
cell carcinoma (ESCC).
- Gained alignment with FDA on the planned Phase 3 trial design
in 2024 and received initial feedback from European regulatory
authorities on proposed trial design.
Emerging Pipeline
Anticipated Milestones for 2025 and Key 2024 Accomplishments
- INO-4201: potential booster to ERVEBO®
- Finalize Phase 2 trial protocols and seek funding to support
trial activities.
- Submit data from completed Phase 1b trial to a peer-reviewed publication,
including FANG assay data indicating that boosting with INO-4201
elicits neutralizing antibody response comparable to that achieved
by ERVEBO, an approved primary series vaccination against
Ebola.
- DNA encoded monoclonal antibody (DMAb) targeting SARS-CoV-2
- Report first clinical data from ongoing Phase 1 trial in first
quarter of 2025.
- The trial, now in its third year, is led by the Wistar
Institute in collaboration with AstraZeneca, the University of Pennsylvania, and Indiana University and is being funded by
DARPA.
- INO-5401
- Continue to dose patients in the GBM-001 Phase 1 trial in newly
diagnosed glioblastoma that combines INO-5401 with Regeneron's PD-1
checkpoint inhibitor Libtayo®. Next development step is to conduct
a controlled Phase 2 trial.
- The Basser Center at the University of
Pennsylvania is evaluating the tolerability and
immunogenicity of INO-5401 in a Phase 1 study exploring the
potential to prevent cancer in people with BRCA1 or BRCA2
mutations.
- INOVIO's partner, ApolloBio, continues recruitment into its
Phase 3 trial evaluating INO-3100 as a potential treatment for HPV
16/18 positive cervical dysplasia in China.
General Corporate
- Strengthened balance sheet with total net proceeds of more than
$60 million from two offerings of
equity securities in April and December
2024. At September 30, 2024,
INOVIO had $84.4 million in cash,
cash equivalents and short-term investments, which does not reflect
the approximately $27.6 million
received from the December 2024
offering.
- Announced appointment of Steven
Egge as Chief Commercial Officer in July 2024. Mr. Egge has broad commercial and
therapeutic area experience, including in HPV-related diseases and
cancers, vaccines and rare diseases, and has overseen or
contributed to more than a dozen commercial product launches
throughout his career.
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.
Forward-Looking Statements
This press release contains
certain forward-looking statements relating to our business,
including the planned initiation and conduct of pre-clinical
studies and clinical trials and the availability and timing of data
from those studies and trials, the resolution of manufacturing
issues, the planned submission of a BLA in mid-2025, and the
potential commercial launch of INO-3107 if regulatory approval is
obtained. 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, 2023, our Quarterly
Report on Form 10-Q for the quarter ended September 30, 2024, 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.
Contacts
Media: Jennie
Willson (267) 429-8567 communications@inovio.com
Investors: Peter Vozzo, ICR
Healthcare, 443-213-0505 investor.relations@inovio.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/inovio-highlights-anticipated-2025-milestones-and-2024-key-accomplishments-302346813.html
SOURCE INOVIO Pharmaceuticals, Inc.
