Memorandum of Understanding builds on recent regulatory authorization from INVIMA to conduct INNOVATE Phase 3 trial for INO-4800, INOVIO's COVID-19 vaccine candidate, in Colombia
Colombia authorization augments recent regulatory authorizations from Brazil, the Philippines and Mexico to commence its COVID-19 vaccine candidate Phase 3 efficacy trial
PLYMOUTH MEETING, Pa., Oct. 21, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced the signing of a non-binding memorandum of understanding (MOU) with Colombia's Ministry of Health and Social Protection reflecting the intent to advance efforts to combat the pandemic and endemic threat posed by COVID-19 and to better prepare for future public health emergencies. The MOU creates a framework for a collaboration arrangement under which INOVIO and the government plan to explore knowledge sharing, technology licensing, and capacity building that support developing and producing vaccines and other biopharmaceuticals in Colombia. The potential results of these efforts include developing local manufacturing capabilities for INOVIO's DNA medicines and related products and technologies.
Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO's memorandum of understanding with Colombia is a sign of our shared commitment to develop and advance potentially life-saving DNA medicines and vaccines to those in need. This partnership grew out of the intended advantages of INOVIO's DNA medicines platform to address current and future global health threats due to the anticipated stability of its product candidates, speed of design and manufacture, as well as the immune response and tolerability that have been observed to date in clinical trials."
The framework of the planned collaboration builds on INOVIO's recently announced authorization to proceed in Colombia with the Phase 3 segment of its global Phase 2/3 clinical trial, INNOVATE, for INO-4800, the company's DNA vaccine candidate for COVID-19. INOVIO is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) on the INNOVATE Phase 3 segment in multiple countries, with a focus on countries underserved by COVID-19 vaccines throughout Latin America, Asia, and Africa. INOVIO previously announced approvals to conduct the trial in Brazil, the Philippines, and Mexico.
Dr. Fernando Ruiz Gomez, Minister of Health and Social Protection, Republic of Colombia, said, "Today is very special for us. We have a complete circle of what is possible with a North American company for the production of vaccines, including the possibility of integrating the work being carried out by the WHO Solidarity vaccine trial in Colombia that includes INOVIO as one of the four vaccine candidates in the clinical studies. As we discussed in the previous meeting today, the possibility of moving forward quickly is due to INOVIO considering Colombia as a priority country, a gesture that we appreciate, and is indicative of the will of our country and the Ministry of Health to advance the development of vaccines in Colombia."
About INO-4800
INO-4800, INOVIO's DNA vaccine candidate against SARS-CoV-2, is composed of a precisely designed DNA plasmid that is injected intradermally followed by electroporation using a proprietary smart device, which delivers the DNA plasmid directly into cells in the body and is intended to produce a well-tolerated immune response. As one of the only nucleic-acid based vaccines that is stable at room temperature for more than a year, at 37°C for more than a month, has a five-year projected shelf life at normal refrigeration temperature and does not need to be frozen during transport or storage, INO-4800 is anticipated to be well-positioned for a primary series immunization as well as a booster.
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 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 therapeutic candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1, the first of two, Phase 3 trials for precancerous cervical dysplasia, demonstrating ability to destroy and clear both high-grade cervical lesions and the underlying high-risk HPV-16/18. INOVIO is also evaluating INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2/3 clinical trial; the Phase 3 segment of which has received regulatory approvals to begin in Colombia, Mexico, Brazil and Philippines. INOVIO's partners, Advaccine Biopharmaceuticals and International Vaccine Institute, are also evaluating INO-4800 in ongoing clinical trials in China and South Korea, respectively.
Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, Defense Advanced Research Projects Agency/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense/Department of Defense, HIV Vaccines Trial Network, International Vaccine Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium, 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. 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 commercialize DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of pre-clinical studies and clinical trials and the availability and timing of data from those studies and trials, 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 pre-clinical 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 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, 2020 , our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 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 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.
