PLYMOUTH MEETING, Pa.,
Dec. 14, 2021 /PRNewswire/
-- INOVIO (NASDAQ: INO), a biotechnology company focused on
bringing to market precisely designed DNA medicines to help protect
people from infectious diseases and treat cancer and HPV-associated
diseases, today announced updates on the Phase 3 program for
VGX-3100 for HPV-associated cervical high-grade squamous
intraepithelial lesions (HSIL), including a one-year follow-up of
efficacy and safety data in participants from REVEAL1, completing
enrollment in REVEAL2, and advancing its pre-treatment biomarker
candidate for VGX-3100 to be further developed with QIAGEN. In
addition, INOVIO's development partner within Greater China (mainland China, Hong
Kong, Macao, Taiwan), ApolloBio Corp. ("ApolloBio"), dosed
the first participant in a separate Phase 3 trial in China.
Key Updates for VGX-3100:
- REVEAL2 –
INOVIO's second global Phase 3 clinical trial of VGX-3100 for
cervical HSIL is fully enrolled and top-line efficacy and safety
data are expected to be available in 2H22.
- REVEAL1 – INOVIO completed the 52-week safety
follow-up of participants in REVEAL1, INOVIO's first global Phase 3
trial of VGX-3100, and the safety profile of VGX-3100 observed at
Week 36 remained well-tolerated through Week 88. In addition,
participants treated with VGX-3100 who met the primary endpoint at
Week 36 remained clear of HPV-16 and/or HPV-18 at Week 88.
- Pre-treatment Biomarker – INOVIO and QIAGEN
have made progress in biomarker development by identifying
candidate biomarker signatures for VGX-3100 with the intent of
selecting a final signature in a pre-treatment in vitro diagnostic
to improve the primary clinical outcome for biomarker-positive
patients with cervical HSIL.
- Phase 3 Trial in China – The first participant has
been dosed in the Phase 3 trial of VGX-3100 for cervical HSIL in
China. This trial is being run by
ApolloBio and is similar in design to REVEAL2. The trial is
expected to enroll up to 84 participants.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "We are making strong progress in developing
INOVIO's immunotherapies treating HPV-associated cervical HSIL.
Left untreated, cervical HSIL may progress to cancer. VGX-3100 has
the potential to be the first approved immunotherapy and
non-surgical alternative for women with cervical HSIL and we look
forward to advancing our efforts from our Phase 3 studies through
commercialization."
Dr. Jeffrey Skolnik, Senior Vice
President of Clinical Development and Program Lead for VGX-3100,
added, "Completing enrollment for REVEAL2, and reporting on our
long-term data from REVEAL1, are important milestones for VGX-3100
and an opportunity to advance women's health, given the lack of a
non-surgical therapeutic for cervical HSIL. With our two Phase 3
studies now fully enrolled, INOVIO remains on target for the
topline efficacy readout from this study in the second half of
2022."
INOVIO's Phase 3 program in cervical HSIL is assessing the
efficacy of VGX-3100 to regress cervical HSIL, a direct precursor
to cervical cancer, and to eliminate the HPV-16 and/or HPV-18
infection that causes these lesions. The REVEAL studies are
prospective, randomized, double-blind, placebo-controlled trials
evaluating adult women with HPV-16 and/or HPV-18 positive
biopsy-proven cervical HSIL. REVEAL1 provided one-year
post-endpoint safety data for a minimum of 198 participants
randomized, while REVEAL2 will provide efficacy and one-month
safety data for a minimum of 198 participants. For more information
on the REVEAL1 and REVEAL2 studies, please visit clinicaltrials.gov
(search identifier NCT03185013 and NCT03721978, respectively).
INOVIO completed the 52-week safety follow-up of participants in
REVEAL1 and showed that the safety profile of VGX-3100 at Week 36
remained well-tolerated through Week 88. In addition, participants
treated with VGX-3100 who met the primary endpoint at Week 36
remained clear of HPV-16 and/or HPV-18 at Week 88. There was no
substantial change in the per-protocol assessment of primary
efficacy from the mITT analysis that was previously reported for
REVEAL1 (link).
Additionally, INOVIO is advancing its partnership with QIAGEN to
co-develop a liquid biopsy-based diagnostic product based on
next-generation sequencing (NGS) technology to guide clinical
decision-making for the use of VGX-3100 in cervical HSIL. This
biomarker, if validated, has the potential to increase the
probability of clinical response in biomarker-positive women with
cervical HSIL. QIAGEN offers an extensive expertise in technologies
from polymerase chain reaction (PCR) to NGS for diagnostic
development. INOVIO anticipates having additional information on
its biomarker development in 2022.
Separately, INOVIO's partner ApolloBio dosed the first
participant in the Phase 3 clinical trial of VGX-3100 in
China. The Phase 3 trial in
China is similar in design to
REVEAL1 and REVEAL2 – randomized, double-blinded,
placebo-controlled. The trial is expected to enroll 84
participants. In 2018, the companies signed an agreement providing
ApolloBio with the exclusive right to develop, manufacture and
commercialize VGX-3100 within Greater
China (link).
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat and protect people
from infectious diseases, cancer, and diseases associated with HPV.
INOVIO has clinically shown that a DNA vaccine candidate can be
delivered directly into cells in the body via a proprietary smart
device to produce a robust and tolerable immune response. INOVIO is
evaluating candidate VGX-3100 in two Phase 3 trials for
precancerous high-grade cervical dysplasia caused by HPV-16 and/or
HPV-18. INOVIO is also evaluating INO-4800, a DNA vaccine candidate
against COVID-19, in a Phase 2/3 clinical trial; the Phase 3
segment of which has received regulatory approvals to proceed in
Colombia, Mexico, Brazil, Philippines, India, Thailand, and the
United States. INOVIO's partners, Advaccine
Biopharmaceuticals and International Vaccine Institute, are also
evaluating INO-4800 in ongoing clinical trials in China and South
Korea, respectively.
Partners and collaborators include Advaccine, ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations, Defense Advanced
Research Projects Agency/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense/Department
of Defense, HIV Vaccines Trial Network, International Vaccine
Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium,
National Cancer Institute, National Institutes of Health, National
Institute of Allergy and Infectious Diseases, Ology Bioservices,
the Parker Institute for Cancer Immunotherapy, Plumbline Life
Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher
Scientific, University of Pennsylvania,
Walter Reed Army Institute of Research, and The Wistar Institute.
For more information, visit www.inovio.com.
CONTACTS:
Media: Jeff Richardson,
267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, 484-362-0076,
ben.matone@inovio.com
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA medicines, our expectations regarding our research and
development programs, including the planned initiation and conduct
of preclinical studies and clinical trials and the availability and
timing of data from those studies and trials, and our ability to
successfully manufacture and produce large quantities of our
product candidates if they receive regulatory approval. 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,
our ability to secure sufficient manufacturing capacity to mass
produce our product candidates, 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 our 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, 2020, our
Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 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 final
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.
View original
content:https://www.prnewswire.com/news-releases/inovio-highlights-key-updates-on-phase-3-program-for-vgx-3100-its-dna-based-immunotherapy-for-the-treatment-of-cervical-hsil-caused-by-hpv-16-andor-hpv-18-301443997.html
SOURCE INOVIO Pharmaceuticals, Inc.