-- 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.