Country for PR: United States
Contributor: PR Newswire New York
Thursday, October 21 2021 - 23:00
AsiaNet
INOVIO Announces Collaboration with Colombia; Memorandum of Understanding Focuses on Protecting Against COVID-19 and Supporting Broader Health Preparedness Initiatives
PLYMOUTH MEETING, Pa., Oct. 21, 2021 /PRNewswire-AsiaNet/ --

-- Memorandum of Understanding builds on recent regulatory authorization from 
INVIMA to conduct INNOVATE Phase 3 trial for INO-4800, INOVIO's COVID-19 
vaccine candidate, in Colombia

-- Colombia authorization augments recent regulatory authorizations from 
Brazil, the Philippines and Mexico to commence its COVID-19 vaccine candidate 
Phase 3 efficacy trial 

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 the signing of a 
non-binding memorandum of understanding (MOU) with Colombia's Ministry of 
Health and Social Protection reflecting the intent to advance efforts to combat 
the pandemic and endemic threat posed by COVID-19  and to better prepare for 
future public health emergencies. The MOU creates a framework for a 
collaboration arrangement under which INOVIO and the government plan to explore 
knowledge sharing, technology licensing, and capacity building that support 
developing and producing vaccines and other biopharmaceuticals in Colombia. The 
potential results of these efforts include developing local manufacturing 
capabilities for INOVIO's DNA medicines and related products and technologies. 

Photo - 
https://mma.prnewswire.com/media/1666521/INOVIO_MOU_Signing_with_Health_Minister_President_and_Joseph_Kim_Photo.jpg


Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO's memorandum of 
understanding with Colombia is a sign of our shared commitment to develop and 
advance potentially life-saving DNA medicines and vaccines to those in need. 
This partnership grew out of the intended advantages of INOVIO's DNA medicines 
platform to address current and future global health threats due to the 
anticipated stability of its product candidates, speed of design and 
manufacture, as well as the immune response and tolerability that have been 
observed to date in clinical trials."

The  framework of the planned collaboration builds on INOVIO's recently 
announced ( 
https://c212.net/c/link/?t=0&l=en&o=3331078-1&h=4088445012&u=https%3A%2F%2Fir.inovio.com%2Fnews-releases%2Fnews-releases-details%2F2021%2FINOVIO-Expands-INNOVATE-Phase-3-for-INO-4800-its-DNA-Vaccine-Candidate-for-COVID-19-to-include-Colombia-following-Regulatory-Authorization%2Fdefault.aspx&a=announced 
) authorization to proceed in Colombia with the Phase 3 segment of its global 
Phase 2/3 clinical trial, INNOVATE, for INO-4800, the company's DNA vaccine 
candidate for COVID-19. INOVIO is working with partner Advaccine 
Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) on the INNOVATE Phase 3 segment 
in multiple countries, with a focus on countries underserved by COVID-19 
vaccines throughout Latin America, Asia, and Africa. INOVIO previously 
announced ( 
https://c212.net/c/link/?t=0&l=en&o=3331078-1&h=1862454545&u=https%3A%2F%2Fir.inovio.com%2Fnews-releases%2Fnews-releases-details%2F2021%2FINOVIO-Receives-Regulatory-Authorization-to-Conduct-Phase-3-Efficacy-Trial-of-its-COVID-19-DNA-Vaccine-Candidate-INO-4800-in-Mexico%2Fdefault.aspx&a=announced 
) approvals to conduct the trial in Brazil ( 
https://c212.net/c/link/?t=0&l=en&o=3331078-1&h=1429776843&u=https%3A%2F%2Fir.inovio.com%2Fnews-releases%2Fnews-releases-details%2F2021%2FINOVIO-Receives-Authorization-to-Conduct-Phase-3-Efficacy-Trial-of-its-COVID-19-DNA-Vaccine-Candidate-INO-4800%2Fdefault.aspx&a=Brazil 
), the Philippines ( 
https://c212.net/c/link/?t=0&l=en&o=3331078-1&h=1734960929&u=https%3A%2F%2Ftwitter.com%2FInovioPharma%2Fstatus%2F1435937330506915840&a=Philippines 
), and Mexico ( 
https://c212.net/c/link/?t=0&l=en&o=3331078-1&h=984438083&u=https%3A%2F%2Fir.inovio.com%2Fnews-releases%2Fnews-releases-details%2F2021%2FINOVIO-Receives-Regulatory-Authorization-to-Conduct-Phase-3-Efficacy-Trial-of-its-COVID-19-DNA-Vaccine-Candidate-INO-4800-in-Mexico%2Fdefault.aspx&a=Mexico 
).

Dr. Fernando Ruiz Gomez, Minister of Health and Social Protection, Republic of 
Colombia, said, "Today is very special for us. We have a complete circle of 
what is possible with a North American company for the production of vaccines, 
including the possibility of integrating the work being carried out by the WHO 
Solidarity vaccine trial in Colombia that includes INOVIO as one of the four 
vaccine candidates in the clinical studies. As we discussed in the previous 
meeting today, the possibility of moving forward quickly is due to INOVIO 
considering Colombia as a priority country, a gesture that we appreciate, and 
is indicative of the will of our country and the Ministry of Health to advance 
the development of vaccines in Colombia."

About INO-4800

INO-4800, INOVIO's DNA vaccine candidate against SARS-CoV-2, is composed of a 
precisely designed DNA plasmid that is injected intradermally followed by 
electroporation using a proprietary smart device, which delivers the DNA 
plasmid directly into cells in the body and is intended to produce a 
well-tolerated immune response. As one of the only nucleic-acid based vaccines 
that is stable at room temperature for more than a year, at 37 degree 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, 
INO-4800 is anticipated to be well-positioned for a primary series immunization 
as well as a booster. 

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 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 therapeutic candidate 
VGX-3100 met primary and secondary endpoints for all evaluable subjects in 
REVEAL 1, the first of two, Phase 3 trials for precancerous cervical dysplasia, 
demonstrating ability to destroy and clear both high-grade cervical lesions and 
the underlying high-risk HPV-16/18. 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 begin in Colombia, 
Mexico, Brazil and Philippines. 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 and commercialize DNA medicines, our 
expectations regarding our research and development programs, including the 
planned initiation and conduct of pre-clinical 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 , our Quarterly Report on Form 10-Q for the 
quarter ended June 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 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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