Country for PR: United States
Contributor: PR Newswire New York
Tuesday, May 21 2019 - 23:19
AsiaNet
Inovio First to Advance Lassa Fever Candidate Vaccine Into a Clinical Trial
PLYMOUTH MEETING, Pa. and OSLO, Norway, May 21, 2019 /PRNewswire-Asianet/ --

-- Subjects dosed in First-in-Human study of INO-4500 funded by the Coalition 
for Epidemic Preparedness Innovations

-- Planned for emergency use as a stockpiled vaccine

Inovio Pharmaceuticals, Inc. (NASDAQ: INO), together with CEPI, today announced 
it has dosed subjects in a Phase 1, first-in-human clinical trial to evaluate 
INO-4500, its DNA candidate vaccine to prevent infection from the Lassa virus. 
Inovio plans to enroll approximately 60 volunteers in this placebo controlled, 
blinded, dose escalation study evaluating INO-4500 for safety, tolerability and 
immune responses. This Inovio trial represents the first Lassa candidate 
vaccine to enter the clinic. This Inovio-sponsored trial, as well as its 
INO-4500 program, is fully funded through a global partnership with CEPI – the 
Coalition for Epidemic Preparedness Innovations. 

Melanie Saville, Director of Vaccine Development at CEPI, said, "This is an 
important development in our work to accelerate the development of vaccines 
against emerging infectious diseases. With marked increases in the number of 
cases documented in Nigeria over the last two years and outbreaks occurring 
annually, Lassa fever remains a serious public health threat across West 
Africa. We welcome Inovio's work and progress which could pave the way to 
reducing the great suffering caused by this disease."

Dr. J. Joseph Kim, Inovio's President and CEO, said, "Inovio's class-leading 
synthetic nucleic vaccines delivered intradermally with its proprietary 
CELLECTRA(R) efficacy enhancing systems are well suited to rapidly produce 
countermeasures against emerging viral threats potentially protecting large 
populations from a pandemic. Inovio has rapidly advanced several global health 
candidate vaccines, including those against HIV, Ebola, MERS, and Zika, and has 
reported above 90% immune response rates from multiple clinical studies. We 
join our partner CEPI in the shared quest to bring new vaccines to medicine and 
save lives."     

In a previously published paper, Inovio reported that its DNA candidate vaccine 
against Lassa fever provided 100% protection in non-human primates challenged 
with a lethal dose of the virus in a pre-clinical study funded by a $3.5 
million grant from the National Institute of Allergy and Infectious Diseases 
(NIAID). Lassa fever is an acute viral illness that occurs in West Africa and 
can cause recurrent large outbreaks with high case fatality rates in the 
region. There is no licensed vaccine or approved treatment for Lassa fever. 

Leveraging results of this study, Inovio expects to advance its Lassa candidate 
vaccine into a Phase 2 field trial in endemic countries of West Africa later in 
2019/2020. With satisfactory Phase 2 data, CEPI in cooperation with local 
regulatory authorities and the WHO, may stockpile the Inovio vaccine for future 
use throughout the region. For more information on this study.

Last year, Inovio received a $56 million grant from CEPI under which Inovio 
will develop vaccine candidates through Phase 2 against Lassa fever and MERS 
(Middle East Respiratory Syndrome.) The shared goal of Inovio and CEPI is for a 
Lassa vaccine to be available as soon as possible for emergency use as a 
stockpile post-Phase 2 testing.

Inovio's synthetic nucleic acid platform of immunotherapies and vaccines 
deliver optimized synthetic antigen genes into cells with CELLECTRA(R) immune 
enhancing systems, where they are translated into protein antigens that 
activate an individual's immune system to generate robust targeted T cell and 
antibody responses. Inovio's immunotherapies function exclusively in vivo, and 
have generated an antigen-specific immune response against targeted diseases in 
all clinical trials to date.

About Lassa Fever 

Lassa fever, also known as Lassa hemorrhagic fever, is an acute viral disease 
which occurs mostly in West Africa. 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.  This infection is spread through contact with infected rodents.  
Person to person transmission is also possible, via bodily fluids, albeit less 
common.  Lassa virus infection in West Africa is estimated to affect 300,000 
people annually, resulting in approximately 5,000 deaths, as disease and 
infection surveillance has been poor.  Because of difficulties in diagnosing 
Lassa fever and the remoteness in many areas that the disease occurs in, the 
numbers of reported cases and deaths are very likely significantly lower than 
the true 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.  There are no licensed vaccines or 
treatments specifically for Lassa. The case-fatality among patients 
hospitalized for Lassa fever is about 15% to 20%, and in some epidemics 
case-fatality has reached 50% in hospitalized patients -- e.g. in the 2015-2016 
Nigeria portion of the West Africa outbreak. Of the survivors of Lassa fever, 
about one-third have sudden-onset hearing loss. In Nigeria, an unprecedented 
outbreak has been underway this year, with more cases recorded and reported in 
the first two months than in any previous full year there.  From January 1 to 
December 31, 2018, a total 633 confirmed and 20 probable cases were reported to 
the Nigeria Centre for Disease Control with 171 deaths among confirmed cases 
and 20 in probable cases, yielding a 27% case-fatality rate in confirmed 
cases.  

About CEPI 

CEPI is an innovative partnership between public, private, philanthropic, and 
civil organisations launched in Davos in 2017 to develop vaccines to stop 
future epidemics. CEPI has received multi-year funding from Norway, Germany, 
Japan, Canada, Australia, and the Bill & Melinda Gates Foundation, and 
Wellcome. CEPI has also received single-year investments from the government of 
Belgium and the United Kingdom. The European Commission foresees substantial 
financial contributions to support relevant projects through EC mechanisms. 
CEPI has reached over US$ 750 million of its $1 billion funding target. Since 
its launch in January 2017, CEPI has announced three calls for proposals. The 
first call was for candidate vaccines against Lassa virus, Middle East 
Respiratory Syndrome coronavirus (MERS-CoV), and Nipah virus. The second call 
was for the development of platforms that can be used for rapid vaccine 
development against unknown pathogens. The third call is for candidate vaccines 
against Rift Valley fever and Chikungunya viruses. To date, CEPI has committed 
to investing up to $350 million in 12 vaccine candidates (five against Lassa 
virus, four against MERS-CoV, three against Nipah virus) and three vaccine 
platforms to develop vaccines against Disease X. Learn more at CEPI.net. Follow 
us at @CEPIvaccines.

About Inovio Pharmaceuticals Inc. 

Inovio is an innovative biotechnology company focused on the discovery, 
development, and commercialization of its synthetic nucleic technology targeted 
against cancers and infectious diseases. Inovio's proprietary technology 
platform applies antigen sequencing and delivery to activate potent immune 
responses to targeted diseases. The technology functions exclusively in vivo, 
and has been demonstrated to consistently activate robust and fully functional 
T cell and antibody responses against targeted cancers and pathogens. Inovio's 
most advanced clinical program, VGX-3100, is in Phase 3 for the treatment of 
HPV-related cervical pre-cancer. Also in development are Phase 2 
immuno-oncology programs targeting HPV-related cancers, bladder cancer, and 
glioblastoma, as well as platform development programs in hepatitis B, Zika, 
Ebola, MERS, and HIV. Partners and collaborators include AstraZeneca, 
Regeneron, Roche/Genentech, ApolloBio Corporation, GeneOne Life Science, The 
Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness 
Innovations, Defense Advanced Research Projects Agency, National Institutes of 
Health, National Institute of Allergy and Infectious Diseases, National Cancer 
Institute, HIV Vaccines Trial Network, Walter Reed Army Institute of Research, 
The Wistar Institute, and the University of Pennsylvania. For more information, 
visit www.inovio.com.

This press release contains certain forward-looking statements relating to our 
business, including our plans to develop DNA-based immunotherapies, our 
expectations regarding our research and development programs, including the 
planned initiation and conduct of clinical trials and the availability and 
timing of data from those trials. 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 and product 
development programs, 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 
immunotherapies, our ability to support our pipeline of SynCon(R) active 
immunotherapy and vaccine 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, 2018, 
our Quarterly Report on Form 10-Q for the quarter ended March 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.

CONTACTS:

Inovio:

Investors:          Ben Matone, 484-362-0076, ben.matone@inovio.com
Media:              Jeff Richardson, 267-440-4211, jrichardson@inovio.com 

CEPI:

Rachel Grant:    +44(0)7891249190, Rachel.Grant@cepi.net
Jodie Rogers:   +44(0)7917030828, Jodie.Rogers@cepi.net



SOURCE: Inovio Pharmaceuticals, Inc.
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