PLYMOUTH MEETING, Pa.,
Nov. 20, 2020 /PRNewswire/ -- INOVIO
(NASDAQ: INO), a biotechnology company focused on rapidly bringing
to market precisely designed DNA medicines to treat and protect
people from infectious diseases and cancer, announced today
that data from the company's novel combination trial of DNA
medicines INO-5401 and INO-9012 in combination with PD-1 inhibitor
Libtayo® (cemiplimab) in the treatment of newly
diagnosed glioblastoma (GBM), will be presented by Dr. David Reardon in the plenary session at the
Society for Neuro-Oncology (SNO) 2020 Annual Meeting. The study
demonstrated that INO-5401 + INO-9012 with Libtayo, radiation (RT)
and temozolomide (TMZ) are tolerable, immunogenic, and may improve
median survival for patients with newly diagnosed GBM. Survival
data at 18 months showed that 70% (14/20) of MGMT promoter
methylated GBM patients were alive, and 50% (16/32) of MGMT
promoter unmethylated patients, which are the more difficult to
treat group, were alive after 18 months. Median overall survival in
the unmethylated GBM patients was 17.9 months, which compares
favorably to historical controls; Median OS for methylated patients
has not yet been reached and the study is ongoing.
Dr. David Reardon, Clinical
Director of the Center for Neuro-Oncology at the Dana-Farber Cancer
Institute and coordinating principal investigator of GBM-001 said,
"This is a landmark combination trial in which a novel DNA vaccine
is combined with a checkpoint inhibitor and radiation and
chemotherapy. We look forward to continuing to review these
data, with an eye towards those patients who are most likely to
benefit from this innovative approach and to see whether, over
time, there is an extension of survival in these very hard-to-treat
patients. Coupling immune response with clinical outcome may
prove insightful."
Interim data demonstrated that in the MGMT promoter unmethylated
cohort, 19/22 (86%) subjects to date had an IFN-gamma T cell
response that increased over baseline to one or more of the
antigens encoded by INO-5401. In the MGMT promoter methylated
cohort, 16/17 (94%) subjects to date had an IFN-gamma response that
increased over baseline to one or more of the antigens encoded by
INO-5401. The novel combination of INO-5401 + INO-9012 continues to
demonstrate a well-tolerated safety profile when given not only
with radiation and TMZ, but also with PD-1 blockade by Libtayo,
which is being jointly developed by Regeneron and Sanofi.
Dr. Jeffrey Skolnik, INOVIO's
senior vice president, clinical development, said, "INO-5401 +
INO-9012, with Libtayo and RT/TMZ, generates cancer
antigen-specific T cells that may be able to attack GBM and provide
a survival advantage. We are using our knowledge of immunology to
define a patient population for which this novel DNA medicine plus
checkpoint inhibitor combination may offer a survival advantage, by
continuing to assess all of our data: efficacy, safety and most
important, immunogenicity and tissue expression data."
Additional data will be provided in the coming months, including
correlative immunology and tissue data, as well as total study drug
exposure and concomitant medication use.
INO-5401, INO-9012 and Libtayo, and the combination of these
products have not been approved or evaluated by any Regulatory
Authority worldwide for the treatment of newly diagnosed GBM.
Presentation Details
Abstract: LTBK-01
Title: "INO-5401 and INO-9012 delivered intramuscularly (IM)
with electroporation (EP) in combination with cemiplimab (REGN2810)
in newly diagnosed glioblastoma"
Presenting Author: Dr. David
Reardon
Plenary Session Date and Time: 2020 SNO Annual Meeting, Plenary 1A,
Friday, November 20, 2020 beginning
at 11 a.m. EST
Study Design
The trial was designed to evaluate safety, immunogenicity and
efficacy of INO-5401 and INO-9012 in combination with Libtayo, with
radiation and chemotherapy, in subjects with newly diagnosed
glioblastoma (GBM). This is a Phase 1/2, open-label, multi-center
trial conducted in 52 evaluable patients with GBM. There are two
cohorts in this trial. Cohort A includes 32 participants with a
tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid
(DNA) methyltransferase (MGMT) promoter. Cohort B includes 20
participants with a tumor with a MGMT methylated promoter. Both
cohorts received INO-5401 and INO-9012 and Libtayo at the same
doses and on the same dosing schedule, and both cohorts received
radiation and TMZ. For more information of the clinical study,
see www.clinicaltrials.gov, identifier NCT03491683.
About Glioblastoma Multiforme (GBM)
GBM is the most common and aggressive type of brain cancer and
remains a devastating disease for both patients and caregivers. Its
prognosis is extremely poor, despite a limited number of new
therapies approved over the last 10 years. The median overall
survival for patients receiving standard of care therapy is
approximately 15 to 22 months and the median progression-free
survival is approximately 7 months. In the U.S., the estimated
annual incidence of GBM is 11,362 cases or 3.21 cases per 100,000
persons and the median age at diagnosis is 65 years.
About INO-5401 and INO-9012
INO-5401 encodes for INOVIO's SynCon® antigens for
hTERT, WT1, and PSMA, and has the potential to be a powerful cancer
immunotherapy in combination with checkpoint inhibitors. The
National Cancer Institute previously highlighted hTERT, WT1, and
PSMA among a list of important cancer antigens, designating them as
high priorities for cancer immunotherapy development. These three
antigens were reported to be over-expressed, and often mutated, in
a variety of human cancers, and targeting these antigens may prove
efficacious in the treatment of patients with cancer. INO-9012
encodes for IL-12, which is a T cell immune activator.
About INOVIO's DNA Medicines Platform
INOVIO has 15 DNA medicine clinical programs currently in
development focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses associated with MERS
and COVID-19 diseases being developed under grants from the
Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S.
Department of Defense. DNA medicines are composed of optimized DNA
plasmids, which are small circles of double-stranded DNA that are
synthesized or reorganized by a computer sequencing technology and
designed to produce a specific immune response in the body.
INOVIO's DNA medicines deliver optimized plasmids directly into
cells intramuscularly or intradermally using INOVIO's proprietary
hand-held smart device called CELLECTRA®. The CELLECTRA device uses
a brief electrical pulse to reversibly open small pores in the cell
to allow the plasmids to enter, overcoming a key limitation of
other DNA and other nucleic acid approaches, such as mRNA. Once
inside the cell, the DNA plasmids enable the cell to produce the
targeted antigen. The antigen is processed naturally in the cell
and triggers the desired T cell and antibody-mediated immune
responses. Administration with the CELLECTRA device ensures that
the DNA medicine is efficiently delivered directly into the body's
cells, where it can go to work to drive an immune response.
INOVIO's DNA medicines do not interfere with or change in any way
an individual's own DNA. The advantages of INOVIO's DNA medicine
platform are how fast DNA medicines can be designed and
manufactured; the stability of the products, which do not require
freezing in storage and transport; and the robust immune response,
safety profile, and tolerability that have been observed in
clinical trials.
With more than 2,000 patients receiving INOVIO investigational
DNA medicines in more than 7,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates with potential to meet urgent
global health needs.
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 is the first and only company to have clinically
demonstrated that a DNA medicine can be delivered directly into
cells in the body via a proprietary smart device to produce a
robust and tolerable immune response. Specifically, INOVIO's lead
candidate VGX-3100, currently in Phase 3 trials for precancerous
cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18
in a Phase 2b clinical trial.
High-risk HPV is responsible for 70% of cervical cancer, 91% of
anal cancer, and 69% of vulvar cancer. Also in development are
programs targeting HPV-related cancers and a rare HPV-related
disease, recurrent respiratory papillomatosis (RRP);
non-HPV-related cancers glioblastoma multiforme (GBM) and prostate
cancer; as well as externally funded infectious disease DNA vaccine
development programs in Zika, Lassa fever, Ebola, HIV, and
coronaviruses associated with MERS and COVID-19 diseases. Partners
and collaborators include Advaccine, ApolloBio Corporation,
AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for
Epidemic Preparedness Innovations (CEPI), Defense Advanced Research
Projects Agency (DARPA)/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial
Network, International Vaccine Institute (IVI), Medical CBRN
Defense Consortium (MCDC), 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. INOVIO also is a
proud recipient of 2020 Women on Boards "W" designation recognizing
companies with more than 20% women on their board of directors. For
more information, visit www.inovio.com.
CONTACTS:
Investors: Ben
Matone, 484-362-0076, ben.matone@inovio.com
Media: Jeff Richardson,
267-440-4211, jrichardson@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, 2019, our
Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 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:http://www.prnewswire.com/news-releases/inovio-presents-clinical-results-of-its-dna-medicines-ino-5401--ino-9012-in-novel-combination-with-pd-1-inhibitor-libtayo-cemiplimab-in-the-treatment-of-newly-diagnosed-glioblastoma-multiforme-at-society-for-neuro-oncology-202-301177899.html
SOURCE INOVIO Pharmaceuticals, Inc.