INOVIO to Develop DNA-encoded Monoclonal Antibody (dMAb(R)) Candidates to Treat COVID-19 with Funding from the Defense Advanced Research Projects Agency (DARPA) and the Department of Defense's (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)

PR87269

PLYMOUTH MEETING, Pa., Dec. 15, 2020 /PRNewswire=KYODO JBN/ --

  -- DARPA to fund innovative public-private partnership between INOVIO, The

     Wistar Institute, AstraZeneca, the University of Pennsylvania and Indiana University

  -- $37.6 million grant from DARPA will leverage AstraZeneca's monoclonal

     antibody and INOVIO's DNA-encoded monoclonal antibody (dMAb(R))

     technologies in the fight against COVID-19

  -- COVID-19 dMAbs offer a cost-effective treatment option, are fast to

     administer to subjects, and can be quickly manufactured and scaled up

     compared to traditional recombinant monoclonal antibody-based therapies

  -- dMAbs do not require cold chain transport/storage, and the overall

     approach can be applied beyond COVID-19 for any pathogen or disease that

     can be treated by recombinant monoclonal antibody-based therapies

INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market

precisely designed DNA medicines to treat and protect people from infectious

diseases and cancer, today announced the company and a team of scientists from

The Wistar Institute, AstraZeneca, the University of Pennsylvania, and Indiana

University received a $37.6 million grant from the U.S. Defense Advanced

Research Projects Agency (DARPA), a research and development agency of the U.S.

Department of Defense (DoD) and the Joint Program Executive Office for

Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), to use

INOVIO's innovative DNA-encoded monoclonal antibody (dMAb(R)) technology to

develop anti-SARS-CoV-2-specific dMAbs which could offer versatile capabilities

to function as both a therapeutic and preventive treatment for COVID-19.

Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO's anti-SARS-CoV-2

dMAbs present a unique complement to our DNA vaccine candidate for COVID-19

prevention, INO-4800, which currently is in the Phase 2 segment of our INNOVATE

Phase 2/3 clinical trial with funding from the DoD/JPEO-CBRND, as well as our

other candidates in our DNA medicines platform. This public-private partnership

allows us to not only broaden the scope and application of our DNA medicines

platform across the spectrum of needed COVID-19 treatment modalities, but also

to open the door for better patient administration and more cost-effective,

scalable production of monoclonal antibody products for other infectious

diseases and cancers. We are excited about the potential this funding offers

for both situations requiring immediate clinical response and benefit."

Dario C. Altieri, M.D., President and Chief Executive Officer of The Wistar

Institute, said, "DARPA has recognized the revolutionary potential of dMAb

technology to positively impact lives around the world with the most

cutting-edge scientific solutions. Having assembled an academic-industry

collaboration with laser-focused vision, we are honored to work together and

bring our expertise and innovation to the urgency of this worldwide global health crisis."

As part of DARPA's two-year grant, INOVIO and Wistar teams will construct

COVID-19 dMAb candidates mirroring AstraZeneca's traditional recombinant

monoclonal antibody candidates currently being tested in clinical trials to

treat COVID-19. dMAb candidates can be quickly developed and produced in vivo,

offering a cost-effective and scalable therapeutic and preventive option for

treatment of SARS-CoV-2 virus infection. The dMAb candidates will then be

advanced into preclinical studies and then into rigorous, first-in-human

clinical trials within one year of funding.

Mark Esser, Vice President and Head of Microbial Sciences, AstraZeneca, said,

"We are excited to combine capabilities with this world-class team to evaluate

the potential of these DNA-delivered antibodies to impact the way we can

respond to prevent and treat infection."

Recombinant monoclonal antibodies, which represent the largest segment of

pharmaceutical markets today with more than $100 billion in sales, are designed

to enhance the immune system's ability to regulate cell functions. However, the

technology has some limitations, including long and costly laboratory

development and large-scale production, limited duration of in vivo potency,

and a pharmacokinetic profile that can result in toxicity. INOVIO's dMAb

technology offers a disruptive and differentiated solution to the challenges

and limitations associated with conventional recombinant monoclonal

antibody-based treatments. The company can encode the DNA sequence for a

specific monoclonal antibody in a DNA plasmid and deliver the plasmid directly

into cells of the body using the company's proprietary smart device called

CELLECTRA(R). This specific DNA medicine serves as a genetic blueprint that

instruct the patient's body to build its own highly specific antibodies in vivo.

INOVIO and its collaborators pioneered the development of dMAb(R) technology as

a unique asset to not only combat the COVID-19 pandemic, but also for any

pathogen or disease that can be treated by an antibody therapy, including

cancer. Empowered by more than $80 million in previous development funding from

DARPA, as well as from the Bill and Melinda Gates Foundation and the National

Institutes of Health, INOVIO's dMAb(R) technology offers a breadth of several

unique advantages across disease and pathogen targets, including high

specificity for the target, rapid injection in subjects requiring minimal

clinical settings, rapid manufacturing, low cost of production, and

temperature-stable storage and distribution. In animal studies, dMAbs have also

been applied to both prevent infection as well as to treat infection,

indicating the potential for bimodal application.

About INOVIO's DNA-encoded Monoclonal Antibody Platform

dMAb technology has the potential to overcome the limitations typically

associated with traditional monoclonal antibodies, primarily cost, large-scale

manufacturing and post-production storage and formulation requirements. The

simplified design of a DNA plasmid encoding for monoclonal antibodies

facilitates rapid development, improved product stability, and cost-effective

manufacturing and deployment.

The dMAb(R) platform provides potential new avenues for treating a range of

diseases. The DNA plasmids are delivered directly into cells of the body and

the encoded monoclonal antibody is then produced by the locally transfected

cells. Previously published studies show that a single administration of a

highly optimized DNA-encoded monoclonal antibody targeting Zika virus

(INO-A002) produced a high level of expression of the antibody in the

bloodstream of mice that was protective against lethal animal challenge. INOVIO

initiated the first human study of INO-A002, marking a major step towards the

development of a broad range of INOVIO's dMAb and DNA-encoded Bi-specific T

Cell engagers (dBTE) programs. Additional studies similarly reported data

showing that dMAbs(R) against Ebola, flu, chikungunya, Lyme, and dengue

protected animals against lethal or pathogenic challenge. Anti-tumor dMAb

candidates, including those for PD-1 and CTLA-4 checkpoint inhibitors, have

demonstrated therapeutic effects against prostate, breast, and ovarian cancers

in animal models.

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 2,000 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, currently in Phase 3 trials for precancerous cervical

dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical

trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal

cancer, and 69% of vulvar cancer. 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 manufacture DNA medicines, our

expectations regarding our research and development programs, 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 preclinical 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 our 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, 2019, our Quarterly Report on Form 10-Q for the quarter

ended September 30, 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.