Country for PR: United States
Contributor: PR Newswire New York
Friday, April 23 2021 - 22:00
AsiaNet
INOVIO Planning for ex-US Global Phase 3 Trial for INO-4800
PLYMOUTH MEETING, Pa., April 23, 2021 /PRNewswire-AsiaNet/ --

  -- Given universal eligibility and broad availability of COVID-19 vaccines 
     in the U.S., DoD JPEO-CBRND has notified INOVIO that it will discontinue 
     funding for the Phase 3 INO-4800 trial

  -- INOVIO adjusts INO-4800 clinical development strategy to focus on 
     global unmet COVID-19 vaccine needs

INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market 
precisely designed DNA medicines to treat and protect people from infectious 
diseases, cancer, and HPV-associated diseases, today announced that it is 
planning for a predominantly ex-U.S. Phase 3 trial for its COVID-19 vaccine 
candidate, INO-4800. Given the increasing availability of vaccines authorized 
for emergency use, the Department of Defense 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), will discontinue 
funding for the Phase 3 segment of the INNOVATE trial, while continuing to fund 
the completion of the ongoing Phase 2 segment. In correspondence, JPEO informed 
INOVIO: "The decision results from the changing environment of COVID-19 with 
the rapid deployment of vaccines. This decision is not a reflection of the 
awardee or product, rather a fast-moving environment associated with the former 
Operation Warp Speed on decisions related to future products."

This decision does not impact other work that INOVIO does with the US 
government and is neither a result of the partial clinical hold nor a 
reflection of the data generated to date for INO-4800 vaccine. With existing 
global collaborators such as INOVIO's China partner, Advaccine, and the 
International Vaccine Institute ( 
https://c212.net/c/link/?t=0&l=en&o=3139539-1&h=2180558442&u=https%3A%2F%2Fwww.ivi.int%2F&a=International+Vaccine+Institute 
) (IVI,) the company is planning for a predominantly ex-US global Phase 3 trial 
based on upcoming evaluation of Phase 2 safety and immunogenicity data. INOVIO 
continues to evaluate its pan-COVID variant vaccine, INO-4802, to protect 
against current and future variants of concern, as well as assessing boosting 
capabilities for INO-4800. INOVIO remains well-positioned to support both 
pandemic and endemic vaccine needs with INO-4800 and INO-4802. INOVIO and its 
partners and collaborators look forward to being part of the global solution to 
prevent the spread of COVID-19 – including both current and future variants. 

About INO-4800

INO-4800 is INOVIO's DNA vaccine candidate against SARS-CoV-2, the coronavirus 
that causes COVID-19. INOVIO has extensive experience working with 
coronaviruses and was the first company to initiate a Phase 2a trial for 
INO-4700, a DNA vaccine candidate for a related coronavirus that causes Middle 
East Respiratory Syndrome (MERS).

Composed of an optimized DNA plasmid, INO-4800 is delivered directly into cells 
in the body via a proprietary smart device to produce a robust and tolerable 
immune response. INO-4800 is the only nucleic-acid based vaccine that is stable 
at room temperature for more than a year, at 37°C for more than a month, has a 
five-year projected shelf life at normal refrigeration temperature and does not 
need to be frozen during transport or storage – all of 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(R) 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(R) 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 3,000 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 is the first DNA medicine to achieve efficacy endpoints in a 
Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical 
dysplasia caused by HPV-16 and/or HPV-18. VGX-3100 also demonstrated positive 
Phase 2 efficacy results in separate trials evaluating the treatment of 
precancerous vulvar dysplasia and anal dysplasia. 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 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 and commercialize 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 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 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.
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