INOVIO Initiates Phase 1 Clinical Trial Of Its COVID-19 Vaccine and Plans First Dose Today

INOVIO Pharmaceuticals, Inc.

2020/4/7 14:11

PR83583

 

PLYMOUTH MEETING, Pennsylvania, April 6, 2020 /PRNewswire=KYODO JBN/ --

 

-- Up to 40 Healthy Volunteers To Participate at Two Trial Locations

-- Preclinical Animal Studies Show Promising Immune Responses

-- Rapid Advancement Possible Through a Global Coalition of Collaborators,

Partners, and Funders

 

INOVIO Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the U.S. Food

and Drug Administration has accepted the company's Investigational New Drug

(IND) application for INO-4800, its DNA vaccine candidate designed to prevent

COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in

healthy volunteers beginning this week. The first dosing is planned for today.

 

Dr. J. Joseph Kim, INOVIO's President and CEO, said, "This is a significant

step forward in the global fight against COVID-19. Without a new safe and

effective vaccine, the COVID-19 pandemic is likely to continue to threaten

lives and livelihoods. It also demonstrates the power of our DNA medicines

platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1

clinical testing. Our dedicated team of staff, partners and funders have been

mobilized since the genetic sequence of the virus became available in early

January and continues to work around the clock to ensure that we are rapidly

advancing INO-4800 through this Phase 1 study towards planned efficacy trials."

 

Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations

(CEPI), said, "This development is an important step forward in the world's

search for a COVID-19 vaccine. INOVIO's DNA vaccine platform was one of the

first technologies selected by CEPI to develop a vaccine candidate against

COVID-19. We are pleased to see the rapid advancement of their vaccine

candidate into clinical safety testing. Producing a COVID-19 vaccine within the

next 12 to 18 months is not only a scientific challenge; it will also require

new levels of collaboration and investment across industry and government.

There is still a long road ahead before we have a safe, effective, and globally

accessible vaccine ready for broader use, but today we have reached an

important milestone on that journey."

 

The Phase 1 study of INO-4800 will enroll up to 40 healthy adult volunteers in

Philadelphia, PA (at the Perelman School of Medicine at the University of

Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research),

where screening of potential participants has already begun. Study supplies of

INO-4800 arrived at the sites last week. Each participant will receive two

doses of INO-4800 four weeks apart, and the initial immune responses and safety

data from the study are expected by late summer. Preclinical data, which have

been shared with global regulatory authorities and submitted as part of the

IND, have shown promising immune response results across multiple animal

models. Additional preclinical trials, including challenge studies, will

continue in parallel with the Phase 1 clinical trial.

 

Dr. Ami Shah Brown, INOVIO's Senior Vice President of Regulatory Affairs said,

"Development and manufacture of a new vaccine with preclinical data to support

a first-in-human trial in ten weeks from funding is a major milestone for

INOVIO and our collaborators."

 

To date, preclinical results for INOVIO's COVID vaccine have been consistent

with our completed Phase 1 vaccine study for Middle East Respiratory Syndrome

(MERS), also caused by a coronavirus, in which INOVIO's DNA vaccine was well

tolerated and induced high levels of antibody responses in 95% of subjects,

while also generating broad-based T cell responses in nearly 90% of study

participants. Durable antibody responses to its DNA vaccine (INO-4700) used in

that trial were maintained through 60 weeks following dosing.

 

Upon attaining initial safety and immunogenicity data from Phase 1 studies,

INOVIO plans to advance INO-4800 to Phase 2 efficacy studies as rapidly as

possible. In 10 weeks from funding, INOVIO has manufactured thousands of doses

of INO-4800 to support on-going Phase 1 and planned Phase 2 clinical trials. In

parallel, INOVIO is working to scale up the manufacturing of INO-4800. INOVIO

plans to have one million doses of the vaccine available by year-end for

additional trials and emergency use, pending appropriate regulatory guidance

and funding.

 

"We anticipate rapid enrollment of this initial study," said Pablo Tebas, MD,

infectious disease specialist and professor of Medicine at the Hospital of the

University of Pennsylvania and Principal Investigator of the study. "There has

been tremendous interest in this vaccine among people who want to do what they

can to help protect the greater public from this pandemic as soon as possible."

 

"INOVIO's leadership and the team's experience combined with the consistency of

this DNA technology for clinical translation continue to be a major asset for

the program," said Dr. David B. Weiner, Director of the Wistar Institute's

Vaccine and Immunotherapy Center and Executive Vice President of the Institute.

 

INOVIO has assembled a global coalition of collaborators, partners, and funders

to rapidly advance INO-4800. The scientific team at the Wistar Institute has

provided key research contributions. The INOVIO program has been supported by

generous funding from the Coalition for Epidemic Preparedness Innovations

(CEPI) and the Bill and Melinda Gates Foundation. VGXI, Inc., a wholly-owned

subsidiary of GeneOne Life Science (KSE: 011000) and INOVIO's manufacturing

partner for the last 13 years, enabled the expedited manufacture, testing, and

release of the INO-4800 plasmid clinical product. The U.S. Department of

Defense (DOD) has also funded INOVIO's collaborator Ology Bioservices to

manufacture additional doses of INO-4800.

 

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). 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). CELLECTRA(R) uses a brief electrical pulse to open

small pores in the cell reversibly to allow the plasmids to enter, overcoming a

key limitation of other DNA and mRNA approaches. Once inside the cell, the

plasmids are used by the cell's own machinery to generate specific coded

antigens, which then stimulate an immune response. Administration with the

CELLECTRA device ensures that the DNA medicine is delivered directly into the

body's cells, where it can go to work immediately mounting 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 constructed 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 demonstrated

in clinical trials.

 

With more than 2,000 patients receiving INOVIO investigational DNA medicines in

more than 6,000 applications across a range of clinical trials, INOVIO has a

strong track record of rapidly generating DNA medicine candidates 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, cure, and protect people from

diseases associated with HPV, cancer, and infectious diseases. 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, 90% 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)/DOD, GeneOne Life Science/VGXI, HIV

Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC), National Cancer

Institute, National Institutes of Health, National Institute of Allergy and

Infectious Diseases, Ology Bioservices, Plumbline Life Sciences, Regeneron,

Roche/Genentech, 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, +1-267-440-4211, jrichardson@inovio.com

Investors: Ben Matone, +1-484-362-0076, ben.matone@inovio.com

 

This press release contains certain forward-looking statements relating to our

business, including our plans to develop DNA medicine candidates, including

INO-4800, our expectations regarding our research and development programs, as

well as commercialization activities, including the planned initiation and

conduct of clinical trials, the availability and timing of data from those

trials and our manufacturing and commercialization strategy and tactics. 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 manufacturing and

commercialization activities and outcomes, 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 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.

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