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Saturday, November 21 2020 - 00:00
INOVIO Presents Clinical Results of its DNA Medicines INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo(R) (cemiplimab) in the Treatment of Newly Diagnosed Glioblastoma Multiforme at Society for Neuro-Oncology 2020 Annual Meeting
PLYMOUTH MEETING, Pennsylvania Nov. 20, 2020 /PRNewswire-AsiaNet/ --

-- Interim review in newly diagnosed glioblastoma patients provides OS18 data, 
demonstrates immunogenicity and tolerability in a majority of patients 

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(R)(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 

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, identifier 

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(R)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(R). 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.


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


Investors: Ben Matone, +1-484-362-0076, 
Media: Jeff Richardson, +1-267-440-4211,

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.
SOURCE:  INOVIO Pharmaceuticals, Inc.