AsiaNet  88193

PLYMOUTH MEETING, Pa., Feb. 23, 2021 /PRNewswire=KYODO JBN/ --

  -- Phase 1B clinical trial is first study for Lassa fever conducted in Africa

  -- Goal is for vaccine to be available for emergency use as stockpile product

     following Phase 2

  -- Progress on INO-4500 reflects INOVIO's focus on and continued commitment

     to the fight against infectious diseases

  -- Trial fully funded by the Coalition for Epidemic Preparedness (CEPI)

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 first participant was dosed in a Phase

1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, in

Ghana. The Phase 1B clinical trial (LSV-002), ongoing at the Noguchi Memorial

Institute for Medical Research in Accra, Ghana, is the first vaccine clinical

trial for Lassa fever to be conducted in West Africa, where the infection is

endemic. INO-4500 is also the first vaccine candidate for Lassa fever to enter

human trials.

INOVIO is advancing INO-4500 with full funding from the Coalition for Epidemic

Preparedness Innovations (CEPI), a global partnership that leverages funding

from public, private, philanthropic, and civil society organizations to support

research projects to develop vaccines against emerging infectious diseases.

INOVIO previously received a $56 million grant from CEPI in 2018, under which

the company is developing vaccine candidates for Lassa fever and Middle East

Respiratory Syndrome (MERS). INOVIO and CEPI are committed to making a vaccine

available as soon as possible for emergency use as a stockpile product

post-Phase 2 testing.

Dr. J. Joseph Kim, President and CEO of INOVIO, said, "We have observed that

INO-4500 vaccination generates robust antibody and T cell immune responses in a

Phase 1 clinical trial conducted in the U.S., and this continued advancement of

INO-4500 into Phase 1B trial is another important step in a  fight against

Lassa fever. This trial also represents a significant advancement within

INOVIO's infectious disease portfolio and further validates the company's DNA

medicines platform and proprietary CELLECTRA(R) delivery device."

Dr. Kim added, "This is the same device being used to deliver our DNA vaccine

candidate, INO-4800, in the Phase 2 segment of our INNOVATE Phase 2/3 COVID-19

trial. We are grateful to CEPI for the continued support and confidence in our

vaccine programs - and we look forward to advancing INO-4500 as a vaccine

candidate against Lassa fever."

Dr Melanie Saville, Director of Vaccine R&D at CEPI, said, "We are delighted to

see our partner INOVIO launch the first-ever Lassa vaccine trial on the African

continent, with today's announcement marking an important milestone in the

fight against this deadly hemorrhagic fever. With the emerging infectious

disease remaining a serious public health threat across West Africa, including

Ghana, it is crucial that populations can participate in vaccine trials to

ensure sufficient data is generated so that they can be confidently rolled out

in outbreak-prone areas in the future, dependent on safety and immunogenicity

testing. Together, this work plays into broader research efforts led by CEPI to

minimize the threat of the disease, including the launch of the largest-ever

Lassa fever epidemiology research program launched in West Africa late last

year."

Professor Kwadwo A. Koram, Principal Investigator of the clinical trial and

head of Noguchi Medical Center, said, "I see this as a great opportunity to use

the resources of the Institute for the benefit not only of the country but the

sub-region at large. We are grateful to the sponsor, INOVIO Pharmaceuticals,

and hope that this will be only the beginning of a long and fruitful

collaboration in the fight against infectious diseases."

About INOVIO's Phase 1B Clinical Trial for INO-4500

INOVIO's Phase 1B clinical trial, LSV-002, will enroll approximately 220 adult

participants who are 18-50 years old, with the primary endpoints of evaluating

safety and immunogenicity in an African population. The dosing regimen involves

two vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing levels.

In addition to providing valuable insights on the INO-4500 safety and

immunogenicity profile, this trial will inform dose selection for subsequent

Phase 2 studies in West Africa.

Since its establishment in 1979, the Noguchi Memorial Institute for Medical

Research ("The Institute") has gained global recognition as a leading

biomedical research institute in Africa, building capacity for prevention and

control of endemic diseases, as well as emerging and re-emerging diseases, in

Ghana and the West African sub-region.  The Institute has been a leader in

developing effective diagnosis capabilities and clinical research for the

treatment and protection against HIV/AIDS, H1N1 Pandemic Flu, Lassa fever,

Yellow fever, Ebola virus disease, and malaria. The lead clinical Principal

Investigator for LSV-002 is Professor Dr. Kwadwo A. Koram, an expert and

specialist in tropical medicines and epidemiologist with more than 20 years of

research experience, including malaria vaccines.  

About Lassa Fever

Lassa fever is an animal-borne, acute hemorrhagic viral illness primarily

observed in parts of West Africa. Infection is spread through contact with

infected rodents, as well as person-to-person transmission via bodily fluids

(primarily in health care settings). The disease can cause a range of outcomes,

including fever, vomiting, and swelling of the face, pain in the chest, back

and abdomen, bleeding of various parts of the body including the eyes and nose,

and death. Lassa virus infection in West Africa is estimated to affect 100,000

to 300,000 people annually and is responsible for 10-16% of hospital admissions

in the region. The virus is responsible for approximately 5,000 deaths annually.

Because of difficulties in diagnosing Lassa fever, the lack of standardized

surveillance assays, and the remote nature of many of the areas in West Africa

where outbreaks typically occur, the numbers of reported cases and deaths are

very likely significantly lower than the actual numbers of cases and deaths.

Though the majority (about 80%) of Lassa virus-infected persons are

asymptomatic or have mild symptoms, the infection can be quite serious to fatal

in others. The case-fatality among patients hospitalized for Lassa fever is

about 15-20% and, in some epidemics, case-fatality has reached 50% in

hospitalized patients. There are no licensed vaccines or treatments

specifically for Lassa fever.  

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 3,000 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.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and

civil organizations, launched at Davos in 2017, to develop vaccines to stop

future epidemics. CEPI has moved with great urgency and in coordination with

WHO in response to the emergence of COVID-19. CEPI has initiated 11

partnerships to develop vaccines against the novel coronavirus. The programs

will leverage rapid response platforms already supported by CEPI as well as new

partnerships. The aim is to advance COVID-19 vaccine candidates into clinical

testing as quickly as possible.

Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus,

Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift

Valley fever and Chikungunya virus. CEPI also invested in platform technologies

that can be used for rapid vaccine and immunoprophylactic development against

unknown pathogens (Disease X). Follow our news page (

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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.