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INOVIO to Give Eight Presentations at the 34th International Papillomavirus Conference

November 15, 2021

PLYMOUTH MEETING, Pa., Nov. 15, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases, and help treat cancer, and HPV-associated diseases, announced today that eight company-sponsored presentations will be given this week at the 34th International Papillomavirus Conference (IPVC) , which is being held virtually from today, November 15 through Friday, November 19.

"The IPVC meeting provides INOVIO with an exciting opportunity to showcase our work to develop treatments for HPV-driven diseases, as well as to advance the understanding of the epidemiology and standard of care in these disease states," said Jeffrey Skolnik, M.D., SVP, Clinical Development at INOVIO. "These data highlight our continued commitment to developing medicines, technologies and solutions to help address the unmet needs of patients across the spectrum of HPV diseases."

INOVIO will give two oral presentations and one featured e-poster presentation from its VGX-3100 clinical trials. VGX-3100 is in Phase 3 clinical trials to study the immunotherapy candidate for the treatment of cervical high-grade squamous intraepithelial lesions (HSIL) and in Phase 2 clinical trials to study the immunotherapy candidate for the treatment of anal and vulvar HSIL.

INOVIO also will present a poster on its INO-3107 Phase 1/2 clinical trial protocol to assess the safety, immunogenicity and efficacy of its use for the potential treatment of recurrent respiratory papillomatosis (RRP) in adults.

In partnership with Optum Life Sciences, another oral presentation will detail the U.S. epidemiology burden of cervical HSIL and a comprehensive assessment of the effectiveness and safety of the cervical HSIL standard of care in the United States. Additional oral and poster presentations given jointly with Optum Life Sciences will address the U.S. epidemiology burden of anal and vulvar HSIL and RRP.

The following INOVIO-sponsored data will be presented at IPVC 2021:

  • VGX-3100 for the Treatment of HPV16/18 Related Cervical HSIL: Results from a Phase 3 Study (Abstract #233)
  • Results of VGX-3100 for the Treatment of HPV16/18 Associated Vulvar HSIL: Phase 2 Open-Label Trial Efficacy and Safety Results (Abstract #164)
  • VGX-3100 for the Treatment of HPV16/18 Attributable Anal HSIL: Results of a Phase 2 Study (Abstract #235)
  • Evaluation of INO-3107 – A Novel DNA Immunotherapy for the Treatment of HPV6/11 Associated Recurrent Respiratory Papillomatosis (Abstract #247)
  • Cervical HSIL – U.S. Burden and Comprehensive Assessment of Standard of Care Effectiveness and Safety, 2008-2018: The EACH-WOMAN Project (Abstract #244)
  • Vulvar High-Grade Squamous Intraepithelial Lesion (HSIL): U.S. Epidemiology burden in the Post-HPV Vaccine Introduction Era, 2015-2019 (Abstract #156)
  • Anal High-Grade Squamous Intraepithelial Lesion (HSIL): U.S. Epidemiology Burden in the Post-HPV Vaccine Introduction Era, 2015-2019 (Abstract #161)
  • Recurrent Respiratory Papillomatosis (RRP) – All-Ages U.S. Prevalence in 2018 (Abstract #173)

About INOVIO's DNA Medicines Platform

INOVIO currently has 15 clinical development programs focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with COVID-19 and MERS. "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 vaccine and immunotherapy candidates deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA® device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, which is designed to overcome 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® device is designed to ensure that the vaccine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's vaccine candidates do not interfere with or change in any way an individual's own DNA. The potential advantages of INOVIO's vaccine platform include how quickly DNA vaccine candidates can be designed and manufactured; the stability of the vaccine candidates, which do not require freezing in storage and transport; and the immune response and tolerability that have been observed in clinical trials.

With more than 3,900 patients receiving INOVIO investigational vaccine candidates in more than 12,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating vaccine candidates with potential to meet urgent global health needs.

About INOVIO

INOVIO is a biotechnology company with a goal 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 vaccine candidate 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 vaccine 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, Philippines, India, Thailand and the United States. 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, our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval and planned collaborations with third parties. 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 September 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.

 

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SOURCE INOVIO Pharmaceuticals, Inc.

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