PR91329

PLYMOUTH MEETING, Pa., Aug. 26, 2021 /PRNewswire-=KYODO JBN/ --

  -- INOVIO's global Phase 3 efficacy trial receives authorization to

     proceed from Brazil; other countries to follow

  -- INOVIO to conduct INNOVATE Phase 3 efficacy trial with partner

     Advaccine in areas of world in need of COVID-19 vaccines

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 has

received regulatory authorization from Brazil's ANVISA (https://c212.net/c/link/?t=0&l=en&o=3271287-1&h=3800759929&u=https%3A%2F%2Fwww.gov.br%2Fanvisa%2Fpt-br%2Fassuntos%2Fnoticias-anvisa%2F2021%2Fanvisa-autoriza-12o-estudo-clinico-de-vacina-contra-covid-19&a=ANVISA) (Agência Nacional de Vigilância Sanitária), the national health regulatory

agency of Brazil, to initiate the global Phase 3 segment of its Phase 2/3

trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), for INO-4800, its

DNA vaccine candidate for COVID-19. INOVIO plans to conduct the global INNOVATE

Phase 3 segment in multiple countries, including Brazil, with partner Advaccine

Biopharmaceuticals Suzhou Co., Ltd. (Advaccine).

The global Phase 3 segment of the INNOVATE Phase 2/3 clinical trial will

evaluate the efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose),

administered one month apart, in a two-to-one randomization in men and

non-pregnant women 18 years of age and older in several countries across Latin

America, Asia, and Africa. The primary endpoint of this case-driven Phase 3

trial is virologically confirmed COVID-19.

Dr. J. Joseph Kim, President and CEO of INOVIO, said, "With many countries in

the world experiencing low vaccination rates and seeing an increase in

infections, we feel the urgency to advance INO-4800 globally. I am incredibly

proud of the INOVIO team and grateful to the health authorities in Brazil for

their commitment to advancing the fight against COVID-19. INOVIO's focus on

supporting the global response to the pandemic is unwavering – and will bring

forward the potential advantages of INO-4800, which in addition to being

well-tolerated with balanced neutralizing antibodies and T cell responses (CD8

and CD4), has a strong thermostability profile, and potentially offers the

ability to serve as both a primary as well as a booster vaccine."

INOVIO's DNA medicines have shown the following overall characteristics:

  - Well-tolerated and Easy to Administer: INO-4800 has a strong safety profile

and, unlike other COVID-19 vaccine candidates, INO-4800 is administered

intradermally and has caused only very limited side effects (mostly mild

injection site reactions).

  - Immunogenic: INO-4800 demonstrated robust immune responses: 100% of Phase 1

participants demonstrated overall immunological response rates and had balanced

neutralizing antibodies and favorable T-cell responses (CD8 and CD4).

  - Stable and Transportable: INO-4800 has a favorable thermostability profile.

The vaccine candidate is projected to be stable at room temperature for more

than a year, at 37°C for more than a month, has a 3 to 5-year projected shelf

life at 2-8°C and does not need to be frozen during transport or storage – a

critical element when considering the feasibility of global distribution.

  - Characterizable and Scalable: INO-4800 is highly characterizable, scalable

to population levels, and safe. The highly characterizable nature of the

vaccine enables timely scaling of manufacturing with multiple manufacturing

facilities able to be utilized.

  - Repeat Administration: INO-4800 can be safely readministered offering the

potential for seasonal boosting usage without any concerns of generating an

anti-vector response or formulation related issues.

The global Phase 3 segment of the Phase 2/3 INNOVATE trial builds upon the

Phase 2 segment conducted in the U.S., which was funded by the U.S. 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. Results from the trial can be found in the paper

entitled "Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2:

A Preliminary Report of a Randomized, Blinded, Placebo-controlled, Phase 2

Clinical Trial in Adults at High Risk of Viral Exposure," which has been

disclosed in a pre-print in MedRxiv prior to peer review. Early INO-4800

research and development funding were provided by the Coalition for Epidemic

Preparedness Innovations (CEPI) and the Bill & Melinda Gates Foundation. The

Phase 2 data showed INO-4800 was well-tolerated and immunogenic in adults 18

and older. In another previously disclosed study using clinical samples,

INO-4800 was also found to provide broad cross-reactive immune responses,

including neutralizing antibodies and robust T cell responses, against variants

of concern (alpha, beta, gamma and – in subsequent research – delta) – factors

which could be critical in containing the SARS-CoV-2 virus as it shifts from

pandemic to endemic spread.

Earlier this month, INOVIO announced (https://c212.net/c/link/?t=0&l=en&o=3271287-1&h=2214947820&u=https%3A%2F%2Fir.inovio.com%2Fnews-releases%2Fnews-releases-details%2F2021%2FINOVIO-and-Advaccine-Receive-Regulatory-Allowance-for-Two-Heterologous-Prime-Boost-Clinical-Trials-in-China-Using-INO-4800-INOVIOs-COVID-19-DNA-Vaccine-Candidate%2Fdefault.aspx&a=announced) the authorization to proceed in China with

two clinical trials investigating heterologous boosting with INO-4800 through Advaccine as the trial sponsor. Working with Sinovac Biotechnology (Sinovac), Advaccine will evaluate the

safety, tolerability, and immunogenicity of heterologous prime-boost sequential

immunizations using INO-4800 and CoronaVac(R), an inactivated COVID-19 vaccine

developed by Sinovac and authorized for emergency use by the World Health

Organization.

About INO-4800

INO-4800 is INOVIO's DNA vaccine candidate against SARS-CoV-2, the coronavirus

that causes COVID-19. Composed of a precisely designed DNA plasmid, INO-4800 is

injected intradermally followed by electroporation using a proprietary smart

device delivering the DNA plasmid directly into cells in the body and is

intended to produce a well-tolerated 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 which INOVIO believes are important considerations

for mass immunizations.

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 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 global Phase 3 clinical trial, as well

as Phase 2 trials in China and South Korea.

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 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.