PR92499

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=KYODO JBN/ --

-- 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.