Country for PR: United States
Contributor: PR Newswire New York
Tuesday, December 08 2020 - 00:00
INOVIO Doses First Subject in Phase 2 Segment of its INNOVATE Phase 2/3 Clinical Trial for INO-4800, its DNA Medicine to Prevent COVID-19
PLYMOUTH MEETING, Pa., Dec. 7, 2020 /PRNewswire-AsiaNet/ --

INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market 
precisely designed DNA medicines to treat and protect people from infectious 
diseases and cancer, today announced it has dosed its first subject in a Phase 
2 clinical trial evaluating DNA medicine INO-4800, its COVID-19 vaccine 
candidate, as part of its Phase 2/3 clinical trial, called INNOVATE (INovio 
INO-4800 Vaccine Trial for Efficacy). The Phase 2 segment of the trial will 
enroll approximately 400 participants who are 18 years or older at up to 17 
U.S. sites to evaluate safety and immunogenicity in order to confirm the 
dose(s) for the subsequent efficacy evaluation as part of the Phase 3 segment 
of the trial.  INOVIO plans to fully enroll the Phase 2 segment of the trial by 
the end of this month.

INNOVATE is a randomized, blinded, placebo-controlled safety and efficacy 
evaluation of INO-4800 being conducted in adults in the U.S. The INNOVATE trial 
is funded by the U.S. Department of Defense (DoD) Joint Program Executive 
Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) 
in coordination with the Office of the Assistant Secretary of Defense for 
Health Affairs (OASD (HA)) and the Defense Health Agency (DHA). For more 
information about the clinical trial, see, identifier 

Dr. J. Joseph Kim, INOVIO's President & CEO said, "We're  pleased to move into 
the Phase 2 segment of our 2/3 trial on the pathway to establish our DNA 
technology as an integral component of the pandemic response given its 
potential for an outstanding safety profile and its demonstrable 
thermostability. I am particularly grateful for the confidence instilled in us 
by the U.S. Department of Defense, a partnership to ensure that healthcare 
workers, frontline responders, our elderly as well as our military 
servicemembers are protected from COVID-19."

The Phase 2 segment of the trial is designed to evaluate safety, tolerability 
and immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg), in a 
three-to-one randomization to receive either INO-4800 or placebo to confirm the 
more appropriate dosing level(s) for each of three age groups (18-50 years, 
51-64 years and 65 years and older) at high risk of SARS-CoV-2 exposure for the 
subsequent Phase 3 efficacy evaluation. 

The DoD has agreed to provide funding for both the Phase 2 and Phase 3 segments 
of INNOVATE, in addition to the $71 million of funding previously announced in 
June for the large-scale manufacture of the company's proprietary next 
generation smart device CELLECTRA(R) 3PSP and the procurement of CELLECTRA® 
2000 devices.

About the INO-4800 "INNOVATE" Phase 2/3 Clinical Trial 

The lead Principal Investigator for INNOVATE is Dr. Pablo Tebas, Professor of 
Medicine at the Hospital of the University of Pennsylvania. The Phase 2 segment 
of the trial is designed to evaluate safety, tolerability and immunogenicity of 
INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg), in a three-to-one 
randomization to receive either INO-4800 or placebo, to confirm the more 
appropriate dosing level for each of three age groups (18-50 years, 51-64 years 
and 65 years and older) for the subsequent Phase 3 efficacy evaluation. The 
company strives to ensure diversity in enrollment, targeting specific 
populations that are working or residing in environments with high risk of 
exposure to SARS-CoV-2, for whom exposure may be relatively prolonged or for 
whom personal protective equipment (PPE) may be inconsistently used, especially 
in confined settings.

The Phase 3 segment of the INNOVATE remains on partial clinical hold until 
INOVIO satisfactorily resolves the FDA's remaining questions related to the 
CELLECTRA 2000 device that will be used to deliver INO-4800 into the cells of 
the skin. The company plans to satisfy the remaining device questions during 
the conduct of Phase 2 segment and prior to the start of the Phase 3 segment of 
INNOVATE. In the Phase 3 segment of the trial, INOVIO intends to enroll healthy 
men and non-pregnant women 18 years and older, to evaluate the efficacy of the 
proposed dosing level(s) for each age group based on the data from the Phase 2 
evaluation. Participants will be enrolled in a one-to-one randomization to 
receive either INO-4800 or a placebo. The Phase 3 segment will be case-driven 
with the final number of enrollees to be determined by the incidence of 
COVID-19 during the Phase 3 segment. The primary endpoint of the Phase 3 
segment will be virologically-confirmed COVID-19 disease.

About INOVIO's Global Coalition Advancing INO-4800

INOVIO has assembled a global coalition of collaborators, partners and funders 
to rapidly advance the development of INO-4800. To date, the Coalition for 
Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, 
and the U.S. Department of Defense have contributed significant funding to the 
advancement and manufacturing of INO-4800.R&D collaborators to date include the 
Wistar Institute, the University of Pennsylvania, the University of Texas, 
Fudan University and Laval University. INOVIO has partnered with Advaccine and 
the International Vaccine Institute to conduct clinical trials of INO-4800 in 
China and South Korea, respectively. INOVIO is also assessing nonclinical 
efficacy of INO-4800 in several animal challenge models with Public Health 
England (PHE) and Commonwealth Scientific and Industrial Research Organization 
(CSIRO) in Australia. INOVIO is working with a team of contract manufacturers 
including Kaneka Eurogentec, Thermo Fisher Scientific, Richter-Helm BioLogics, 
and Ology Bioservices to manufacture INO-4800 on a commercial scale and is 
seeking additional external funding and partnerships to further scale up 
manufacturing capacities to satisfy the urgent global demand for safe and 
effective vaccines. 

About INO-4800

INO-4800 is INOVIO's prophylactic DNA vaccine candidate against SARS-CoV-2, the 
novel coronavirus that causes COVID-19. INOVIO is leveraging its extensive 
experience with INO-4700, its DNA vaccine against another important 
coronavirus, the Middle East Respiratory Syndrome (MERS), that is soon to be 
evaluated in a Phase 2 clinical trial.

INO-4800 is the only nucleic-acid based vaccine that is stable at room 
temperature for more than a year and does not need to be frozen during 
transport or storage, which are important considerations when preparing for 
mass immunizations.

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), Kaneka Eurogentec, 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


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

This press release contains certain forward-looking statements relating to our 
business, including our plans to develop and manufacture DNA medicines, our 
expectations regarding our research and development programs, including the 
planned initiation and conduct of the Phase 2/3 clinical trial of INO-4800, 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 preclinical 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.