Thermo Fisher Scientific Joins INOVIO's Global Manufacturing Alliance for COVID-19 DNA Vaccine INO-4800

PLYMOUTH MEETING, Pa., Sept. 8, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing precisely designed DNA medicines to market for the treatment and prevention of cancer and infectious diseases, announced today that Thermo Fisher Scientific, the global leader in scientific services, has signed a letter of intent to manufacture INOVIO’s COVID-19 DNA vaccine candidate, INO-4800.

Thermo Fisher Scientific has joined other contract development and manufacturing organizations in INOVIO’s global manufacturing alliance, positioning INOVIO for large-scale commercial production of INO-4800. Leveraging its third-party manufacturer alliance, INOVIO plans to produce 100 million doses in 2021.¹doses of the INO-4800 vaccine, but this requires FDA approval of INO-4800 as a COVID-19 vaccine. Thermo Fisher Scientific plans to manufacture the active pharmaceutical ingredient (API) for INO-4800 and perform drug product fill-finish and subsequent processing at its U.S. commercial manufacturing facility. Thermo Fisher Scientific estimates that, at full production capacity, it can produce at least 100 million doses of INO-4800 annually.

Dr. J. Joseph Kim, President and Chief Executive Officer of INOVIO, stated, “INOVIO welcomes Thermo Fisher Scientific to our global coalition of large-scale commercial vaccine manufacturers, and we look forward to collaborating with them on this critical endeavor. Thermo Fisher Scientific’s global capabilities and scale will be pivotal to our manufacturing progress. With an urgent worldwide need for safe and effective COVID-19 vaccines, Thermo Fisher Scientific’s commitment to high-quality, reliable production will be key to meeting this demand.”

Leon Wyszkowski, President of Commercial Operations for Thermo Fisher Scientific’s Pharmaceutical Services business, stated, “INOVIO has truly recognized the value of our end-to-end capabilities—from the initial work in our clinical trials to supporting their current commercial needs. We will continue to fully support INOVIO’s plan to produce 100 million vaccine doses in 2021.”

Robert J. Juba Jr., Vice President of Biomanufacturing and Clinical Supply Management at INOVIO, stated, “INOVIO is pleased to partner with Thermo Fisher Scientific to manufacture DNA plasmid active pharmaceutical ingredients (APIs) and drug products. Thermo Fisher Scientific provides end-to-end solutions for manufacturing, labeling, packaging, and distribution, which we believe will facilitate the delivery of hundreds of millions of doses of the INO-4800 vaccine to the United States and other regions worldwide.”

Thermo Fisher Scientific will join existing partners Richter-Helm BioLogics and Ology Biosciences as a new member of INOVIO’s global manufacturing alliance. INOVIO is actively discussing with additional manufacturers the possibility of joining this alliance, aiming to secure further manufacturing collaborations, expand the alliance’s roster, and meet global supply demands. Engaging multiple manufacturers in the production of INO-4800 is intended to ensure timely, cost-effective, and scalable production of this DNA vaccine. INOVIO’s third-party manufacturers will produce the patented INO-4800 vaccine formulation, which enhances vaccine stability and ensures good tolerability. Importantly, INO-4800 demonstrates robust thermal stability. Other platform DNA vaccine candidates from INOVIO have shown shelf lives exceeding five years under refrigeration, stability for more than 30 days at 37°C, and stability for over one year at room temperature. Furthermore, INOVIO’s vaccine candidates do not require refrigeration during transportation or storage, a critical factor for implementing immunization programs globally. INO-4800 is administered using INOVIO’s proprietary CELLECTRA® smart delivery device, which locally delivers the vaccine into the patient’s skin within seconds.

INOVIO is conducting Phase I clinical trials of INO-4800 in the United States and has submitted complete trial results for the first 40 participants for publication in a peer-reviewed journal. The company plans to launch a Phase 2/3 clinical trial of its COVID-19 vaccine in September, subject to FDA approval.

Earlier this summer, INOVIO received $71 million in funding from the U.S. Department of Defense to support the large-scale manufacturing of its proprietary CELLECTRA® 3PSP device and the procurement of CELLECTRA® 2000 devices. Prior to securing this Department of Defense funding, the company had separately obtained $5 million each from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) to accelerate the testing of CELLECTRA® 3PSP. The initial development of the next-generation CELLECTRA® 3PSP smart device began in 2019, supported by an $8.1 million grant from the Medical CBRN Defense Consortium of the U.S. Defense Threat Reduction Agency.

Overview of INOVIO’s Global Alliance for INO-4800

INOVIO has established a global alliance of collaborators, partners, and funders to rapidly advance the development of INO-4800. To date, R&D partners include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University, and Laval University (Laval University). Inovio Pharmaceuticals has collaborated with Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively. Inovio has also worked with Public Health England and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) to evaluate the preclinical efficacy of INO-4800 in several animal challenge models. Furthermore, Inovio has partnered with contract manufacturing organizations, including Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Biosciences, for the commercial-scale production of INO-4800, while seeking additional external funding and partnerships to expand manufacturing capacity and meet the urgent global demand for safe and effective vaccines. To date, the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the U.S. Department of Defense have provided substantial funding for the development and production of INO-4800.

Introduction to INO-4800

INO-4800 is Inovio’s DNA vaccine candidate for the prevention of COVID-19. Inovio has extensive experience in developing coronavirus vaccines and is the only company with a MERS coronavirus vaccine in Phase 2 clinical trials.

Introduction to Inovio’s DNA Drug Platform

INOVIO is currently developing 15 clinical DNA drug programs, focusing on human papillomavirus (HPV)-related diseases, cancer, and infectious diseases, including the development of MERS coronavirus and novel coronavirus vaccines funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA drugs consist of optimized plasmid DNA, which are small circular double-stranded DNA molecules synthesized or recombined using computer-aided sequencing technologies, designed to elicit specific immune responses in vivo.

INOVIO’s DNA medicines utilize the company’s proprietary handheld smart device, CELLECTRA®, to deliver optimized plasmids directly into cells via intramuscular or intradermal administration. The user-friendly CELLECTRA device employs a brief electrical pulse to reversibly create small pores in cells within the local skin area, enhancing product delivery by more than 100-fold, thereby enabling dose reduction and ensuring uniformity. Once inside the cells, the plasmid DNA facilitates the production of target antigens. These antigens are naturally processed intracellularly, triggering the desired T-cell and antibody-mediated immune responses. Administration using the CELLECTRA device takes only a few seconds, ensuring efficient and direct delivery of DNA medicines into human cells to drive immune responses. INOVIO’s DNA medicines are transient and do not interfere with or alter an individual’s own DNA in any way. The advantage of INOVIO’s DNA medicine platform lies in its ability to rapidly design and produce DNA medicines. The medicines are stable, requiring no refrigeration during storage and transport, and have been demonstrated in clinical trials to be safe and well-tolerated while sustaining immune stimulation in the human body.

Among more than 7,000 applications across a series of clinical trials, over 2,000 patients received Inovio’s investigational DNA-based therapeutic. Inovio has remained committed to the rapid development of DNA-based drug candidates, effectively supporting the global response to public health emergencies.

Introduction to Inovio

INOVIO is a biotechnology company focused on rapidly bringing precisely designed DNA medicines to market for the treatment and prevention of HPV-related diseases, cancer, and infectious diseases. INOVIO is the first and only company to clinically demonstrate that its DNA medicines can be delivered directly into cells in the body via proprietary smart devices, thereby generating potent and tolerable immune responses. Specifically, the company’s lead candidate, VGX-3100, is currently in Phase 3 clinical trials for the treatment of cervical dysplasia (precancerous abnormalities). Results from its Phase 2b clinical trial showed that the drug can eradicate and clear high-risk HPV types 16 and 18. High-risk HPV infection is responsible for 70% of cervical cancers, 91% of anal cancers, and 69% of vulvar cancers. Ongoing development programs primarily target HPV-related cancers and a rare HPV-induced condition, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers, such as glioblastoma multiforme (GBM) and prostate cancer; and externally funded infectious disease DNA vaccine development programs, primarily targeting Zika virus, Lassa fever, Ebola virus, human immunodeficiency virus (HIV), as well as Middle East Respiratory Syndrome (MERS) coronavirus and SARS-CoV-2. Partners and collaborators include: Advaccine, Beijing Eastern Biologic Pharmaceutical Co., Ltd., AstraZeneca, the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI), the Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/U.S. Department of Defense (DOD), the HIV Vaccines Trial Network, the International Vaccine Institute (IVI), the Medical CBRN Defense Consortium (MCDC), the National Cancer Institute, the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, Thermo Fisher Scientific, the University of Pennsylvania, VGXI, the Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO was also honored with the 2020 Women on Boards “W” Award, which recognizes companies with more than 20% women on their boards of directors. For more information, please visit:www.inovio.com。

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

This press release contains certain forward-looking statements related to the Company’s business, including its plans to develop and manufacture DNA-based medicines; expectations regarding its research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials, the availability and timing of data from such studies and trials, and, if such medicines receive regulatory approval, its ability to successfully manufacture and scale up production of its candidate products. Due to various factors, actual events or results may differ from those anticipated in this release, including uncertainties inherent in preclinical studies, clinical trials, product development plans, commercialization activities, and outcomes themselves; the Company’s ability to secure sufficient manufacturing capacity for large-scale production of candidate products; the availability of funding required to continue research and trials to demonstrate that electroporation technology can be safely and effectively used as a delivery mechanism or to develop viable DNA-based medicines; the Company’s ability to support its pipeline of DNA-based medicine products; the ability of the Company’s collaborators to achieve milestone progress in the development and commercialization of licensed products and in product sales, thereby enabling the Company to receive future payments and royalties; the adequacy of the Company’s capital resources; the availability or potential availability of alternative therapies or treatments for the conditions targeted by the Company or its collaborators, including alternatives that may be more effective or cost-efficient than any therapy or treatment regimen the Company and its collaborators hope to develop; issues involving product liability; patent-related issues, and whether such patents or licenses thereof can effectively prevent others from using the relevant technologies; whether such ownership rights are enforceable, valid, and reliable, or whether they infringe or allegedly infringe upon the rights of others, or are subject to claims of invalidity; and whether the Company can provide the necessary funding or other significant resources to prosecute, protect, or defend these rights; levels of corporate expenditures; assessments of the Company’s technology by potential corporate or other partners or collaborators; capital market conditions; the impact of government proposals on the healthcare industry; and other factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the period ended June 30, 2020, and other documents filed by the Company with the U.S. Securities and Exchange Commission from time to time. There can be no assurance that any candidate product in the Company’s development pipeline will be successfully developed, manufactured, or commercialized, that the final results of clinical trials will support the regulatory approvals required for product sales, or that any forward-looking information contained herein will prove to be accurate. Forward-looking statements speak only as of the date of this press release, and, except as required by law, the Company undertakes no obligation to update or revise these statements.

¹1 mg dose equivalent