IVI, INOVIO, and KNIH to Partner with CEPI in Phase 1/2 Clinical Trial of INOVIO's COVID-19 DNA Vaccine in South Korea
PLYMOUTH MEETING,Pennsylvania and SEOUL,South Korea,April 16,2020 --The International Vaccine Institute (IVI) announced today that the Coalition for Epidemic Preparedness Innovations (CEPI) has granted $6.9 million funding to INOVIO (NASDAQ:INO) to work with IVI and the Korea National Institute of Health (KNIH) for a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine candidate (INO-4800) in South Korea. IVI will conduct the trial in parallel to INOVIO's Phase 1 INO-4800 study currently underway in the US since April 6,2020 with 40 healthy adults receiving the vaccine candidate and eventually expanding to older adults.
Dr. Jerome H. Kim,Director General of IVI,said,"Vaccines are the long-term solution to controlling the COVID-19 pandemic. The rapid global response to developing vaccine candidates has been a profound demonstration of governments,industry,and the scientific community coming together to confront a common crisis,and we're looking forward to accelerating one of those candidates through clinical testing. IVI has achieved promising trial results with INOVIO's DNA vaccine platform in the past,and we're pleased to partner again to test the safety and immunogenicity of an urgently needed COVID-19 vaccine."
Dr. J. Joseph Kim,INOVIO's President and CEO,"Developing a safe and effective COVID-19 vaccine is a global imperative,and we're pleased to partner with IVI and KNIH to test INO-4800 in South Korea. Our DNA vaccine platform was one of the first technologies to receive support from CEPI to accelerate a COVID-19 vaccine,and IVI conducting safety and efficacy trials in South Korea is a crucial step forward in evaluating this vaccine."
Dr. Richard Hatchett,CEO of CEPI said,"Developing a safe and effective vaccine and ensuring its global supply is our best exit strategy from the COVID-19 pandemic. CEPI is pleased to work with INOVIO and IVI in this critical next stage of testing."
INOVIO's DNA vaccine platform is also utilized in their MERS vaccine,INO-4700,for which IVI previously conducted Phase I clinical testing with GeneOne Life Science in South Korea.
This news follows the announcement from the Korean Ministry of Food and Drug Safety made on April 13th that they will adopt a fast-track approval process for COVID-19 vaccine and treatment clinical trials. The period of clinical trial screening will be shortened to seven days (down from 30 days) for substances with experience in use and within 15 days for new materials. Additionally,vaccines developed with a proven safety platform,such as INOVIO's DNA platform,will be exempt from toxicology tests which will minimize data submission and expedite clinical trials. Plumbline Life Sciences (XKRX: 222670) of South Korea also collaborated on this project. Korea Centers for Disease Control and Prevention (KCDC) and the KNIH and has also pledged their support for IVI's testing efforts.
About Global Coalition Advancing INO-4800
INOVIO has assembled a global coalition of collaborators,partners and funders to rapidly advance INO-4800. R&D collaborators to date include the Wistar Institute,the University of Pennsylvania,the University of Texas,Twist Biosciences,and the Lavalle University. INOVIO has partnered with Beijing Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea,respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organisation (CSIRO) in Australia. INOVIO is also working with a team of contract manufacturers including VGXI,Inc.,Richter-Helm,and Ology Biosciences to produce up to one million doses of INO-4800 by year end and seeking additional external funding and partnerships to scale up the manufacturing capacities to satisfy urgent global demand for safe and effective vaccine. To date,the Coalition for Epidemic Preparedness Innovations (CEPI),the Bill & Melinda Gates Foundation,and the US Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800.
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a nonprofit inter-governmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP).
Headquartered in Seoul,IVI was the first international organization hosted by Korea. IVI has 35 signatory countries and the World Health Organization (WHO) on its treaty,including Republic of Korea,Sweden and India as state funders.
Our mandate is to make vaccines available and accessible for the world's most vulnerable people. We focus on infectious diseases of global health importance such as cholera,typhoid,shigella,salmonella,schistosomiasis,Group A Streptococcus,Hepatitis A,HPV,TB,HIV,MERS,COVID-19,as well as antimicrobial resistance. For more information,please visit https://www.ivi.int.
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,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.
About CEPI
CEPI is an innovative partnership between public,private,philanthropic,and civil society 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 8 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).
CONTACTS
IVI Media:
Youngmi Cho,Head of Global Affairs & Communications,+82-2-881-1439,youngmi.cho@ivi.int
Aerie Em,Global Communications & Media Specialist,+82-2-881-1386,aerie.em@ivi.int
CEPI:
Rachel Grant,Director of Communications and Advocacy,Rachel.Grant@cepi.net
INOVIO Media:
Jeff Richardson,VP Strategic Relations,+1-267-440-4211,jrichardson@inovio.com
INOVIO Investors:
Ben Matone,Senior Director,IR,+1-484-362-0076,ben.matone@inovio.com
This press release contains certain forward-looking statements relating to INOVIO's business,including our plans to develop DNA medicines,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 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 preclinical studies,clinical trials,product development programs 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 vaccines,our ability to support our pipeline of SynCon® 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 31,2019,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.
