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INOVIO Provides Update on COVID-19 Heterologous Booster Vaccine Candidate, INO-4800

October 27, 2022

PLYMOUTH MEETING, Pa., Oct. 27, 2022 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and prevent infectious diseases, cancer, and diseases associated with HPV, today announced that it has discontinued its internally funded efforts to develop INO-4800 as a COVID-19 heterologous booster vaccine. The decision follows INOVIO's comprehensive review of its portfolio, market conditions, and global demand for COVID-19 vaccines.

Dr. Jacqueline Shea, INOVIO's CEO and President, stated: "We continue to believe that our DNA medicine technology has attributes that could be beneficial to a heterologous COVID-19 booster vaccine. However, our assessment of the current global demand for COVID-19 vaccines, changes in regulatory timelines and requirements, diminishing government financial support, and the overall growing uncertainty related to opportunities for heterologous booster vaccines have resulted in our decision to discontinue internal funding efforts to develop INO-4800 as a heterologous booster vaccine. As we work to bring DNA medicines to the marketplace, we will reallocate resources and focus our efforts on other product candidates in our pipeline, such as INO-3107 and INO-5401, both of which recently reported positive Phase 1/2 data for their respective targeted indications in recurrent respiratory papillomatosis and glioblastoma. We continue to expect to be able to report updates in the coming months from our other ongoing trials targeting Cervical High-Grade Squamous Intraepithelial Lesions (REVEAL 2), Ebola, Lassa fever and MERS."

About INO-4800 and Ongoing COVID-19 Studies

INO-4800 is a DNA medicine product candidate that has been studied as a vaccine candidate for COVID-19. It continues to be one of the vaccines being investigated by the World Health Organization as part of their Solidarity Trial Vaccines, which is an international, multi-center, multi-vaccine, adaptive, shared placebo, event-driven, individually randomized controlled clinical trial that aims to evaluate the efficacy and safety of promising new COVID-19 vaccines.

INOVIO's partner in China, Advaccine, will continue to develop INO-4800 as a COVID-19 heterologous booster vaccine with its own resources. Advaccine is currently analyzing the data from its heterologous boost trial with INO-4800. Any future updates on this trial will be provided by Advaccine.

INOVIO plans to continue preclinical efforts to investigate the potential for a pan-COVID-19 vaccine candidate based on its DNA medicines technology. Insights gathered from prior studies with DNA medicine product candidates, including those for INO-4800, will help inform this development effort.


INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO's DNA medicines in development are delivered using its investigational proprietary smart device to produce immune responses against targeted pathogens and cancers.

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Forward-Looking Statements

This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and our expectations regarding our research and development programs, including the availability and timing of data from clinical 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, 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 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, 2021, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, 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 the 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.


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