INOVIO Arranging for ex-US Global Phase 3 Demo for INO-4800

Offered universal eligibility and wide availability of COVID-19 vaccines in the U.S., DoD JPEO-CBRND has notified INOVIO that it will discontinue funding for the Period 3 INO-4800 demo

INOVIO adjusts INO-4800 clinical advancement method to emphasis on world wide unmet COVID-19 vaccine needs

PLYMOUTH Conference, Pa., April 23, 2021 /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company centered on bringing to sector precisely built DNA medicines to handle and safeguard people from infectious disorders, cancer, and HPV-linked conditions, now announced that it is setting up for a predominantly ex-U.S. Section 3 demo for its COVID-19 vaccine prospect, INO-4800. Supplied the raising availability of vaccines authorized for emergency use, the Department of Protection Joint Application Government Office for Chemical, Biological, Radiological and Nuclear Protection (JPEO-CBRND) in coordination with the Business office of the Assistant Secretary of Defense for Well being Affairs (OASD(HA)) and the Defense Well being Agency (DHA), will discontinue funding for the Stage 3 segment of the INNOVATE demo, when continuing to fund the completion of the ongoing Stage 2 section. In correspondence, JPEO informed INOVIO: “The final decision results from the altering atmosphere of COVID-19 with the immediate deployment of vaccines. This conclusion is not a reflection of the awardee or product, fairly a quick-going setting connected with the former Operation Warp Velocity on choices associated to potential products and solutions.”

This final decision does not impact other do the job that INOVIO does with the US authorities and is neither a final result of the partial scientific hold nor a reflection of the knowledge created to date for INO-4800 vaccine. With existing global collaborators such as INOVIO’s China husband or wife, Advaccine, and the Global Vaccine Institute (IVI,) the corporation is preparing for a predominantly ex-US world wide Stage 3 trial centered on future evaluation of Stage 2 protection and immunogenicity details. INOVIO continues to evaluate its pan-COVID variant vaccine, INO-4802, to protect from recent and potential variants of problem, as perfectly as examining boosting capabilities for INO-4800. INOVIO stays nicely-positioned to assistance each pandemic and endemic vaccine demands with INO-4800 and INO-4802. INOVIO and its companions and collaborators search ahead to currently being part of the international alternative to prevent the spread of COVID-19 – which include the two current and future variants.

Tale continues

About INO-4800

INO-4800 is INOVIO’s DNA vaccine prospect towards SARS-CoV-2, the coronavirus that will cause COVID-19. INOVIO has considerable expertise functioning with coronaviruses and was the initially corporation to initiate a Section 2a trial for INO-4700, a DNA vaccine candidate for a related coronavirus that brings about Center East Respiratory Syndrome (MERS).

Composed of an optimized DNA plasmid, INO-4800 is shipped immediately into cells in the physique by means of a proprietary good unit to make a strong and tolerable immune response. INO-4800 is the only nucleic-acid dependent vaccine that is steady at room temperature for a lot more than a calendar year, at 37°C for much more than a month, has a 5-calendar year projected shelf life at standard refrigeration temperature and does not require to be frozen all through transportation or storage – all of which are significant concerns when getting ready for mass immunizations.

About INOVIO’s DNA Medications System

INOVIO has 15 DNA drugs clinical plans at this time in advancement targeted on HPV-related diseases, cancer, and infectious health conditions, like coronaviruses associated with MERS and COVID-19 ailments becoming designed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Division of Protection. DNA medications are composed of optimized DNA plasmids, which are compact circles of double-stranded DNA that are synthesized or reorganized by a laptop or computer sequencing engineering and developed to deliver a distinct immune response in the system.

INOVIO’s DNA medicines supply optimized plasmids right into cells intramuscularly or intradermally making use of INOVIO’s proprietary hand-held good system referred to as CELLECTRA^®. The CELLECTRA^® unit uses a brief electrical pulse to reversibly open tiny pores in the mobile to enable the plasmids to enter, conquering a critical limitation of other DNA and other nucleic acid strategies, such as mRNA. At the time inside the mobile, the DNA plasmids enable the mobile to make the targeted antigen. The antigen is processed normally in the mobile and triggers the sought after T mobile and antibody mediated immune responses. Administration with the CELLECTRA^® gadget ensures that the DNA medication is efficiently sent specifically into the body’s cells, where by it can go to function to drive an immune reaction. INOVIO’s DNA medications do not interfere with or adjust in any way an individual’s personal DNA. The pros of INOVIO’s DNA medicine system are how speedy DNA medications can be designed and produced the stability of the items, which do not call for freezing in storage and transportation and the strong immune response, protection profile, and tolerability that have been observed in medical trials.

With far more than 3,000 patients obtaining INOVIO investigational DNA medications in far more than 7,000 apps across a assortment of scientific trials, INOVIO has a powerful observe report of rapidly building DNA drugs candidates with potential to satisfy urgent global wellbeing desires.

About INOVIO

INOVIO is a biotechnology corporation concentrated on fast bringing to market specifically intended DNA medications to take care of and safeguard people from infectious diseases, most cancers, and illnesses connected with HPV. INOVIO is the first and only organization to have clinically demonstrated that a DNA medication can be shipped instantly into cells in the overall body by means of a proprietary smart machine to make a sturdy and tolerable immune response. Especially, INOVIO’s lead candidate VGX-3100 is the initial DNA drugs to attain efficacy endpoints in a Phase 3 scientific trial, Expose 1, for the procedure of precancerous cervical dysplasia caused by HPV-16 and/or HPV-18. VGX-3100 also demonstrated favourable Period 2 efficacy effects in individual trials evaluating the procedure of precancerous vulvar dysplasia and anal dysplasia. Also in enhancement are courses focusing on HPV-related cancers and a unusual HPV-connected disease, recurrent respiratory papillomatosis (RRP) non-HPV-relevant cancers glioblastoma multiforme (GBM) and prostate most cancers as properly as externally funded infectious disorder DNA vaccine progress plans in Zika, Lassa fever, Ebola, HIV, and coronaviruses involved with MERS and COVID-19 illnesses. Partners and collaborators include things like Advaccine, ApolloBio Company, AstraZeneca, The Invoice & Melinda Gates Basis, Coalition for Epidemic Preparedness Improvements (CEPI), Defense Advanced Investigation Initiatives Agency (DARPA)/Joint Application Executive Office for Chemical, Organic, Radiological and Nuclear Defense (JPEO-CBRND)/Office of Protection (DoD), HIV Vaccines Demo Network, Intercontinental Vaccine Institute (IVI), Kaneka Eurogentec, Healthcare CBRN Protection Consortium (MCDC), National Cancer Institute, Countrywide Institutes of Wellbeing, National Institute of Allergy and Infectious Ailments, Ology Bioservices, the Parker Institute for Most cancers Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Thermo Fisher Scientific, College of Pennsylvania, Walter Reed Army Institute of Study, and The Wistar Institute. INOVIO also is a proud receiver of 2020 Girls on Boards “W” designation recognizing firms with extra than 20% women on their board of administrators. For much more information and facts, visit www.inovio.com.

CONTACTS:

Media: Jeff Richardson, 267-440-4211, [email protected]
Investors: Ben Matone, 484-362-0076, [email protected]

This push launch has specific ahead-on the lookout statements relating to our company, together with our strategies to produce and commercialize DNA medicines, our anticipations concerning our exploration and enhancement packages, including the prepared initiation and carry out of preclinical scientific tests and scientific trials and the availability and timing of info from those research and trials, and our potential to efficiently manufacture and produce significant portions of our merchandise candidates if they acquire regulatory approval. Actual occasions or results may perhaps vary from the anticipations set forth herein as a result of a quantity of components, which includes uncertainties inherent in pre-scientific research, clinical trials, item development packages and commercialization routines and outcomes, our skill to protected enough production capability to mass generate our product candidates, the availability of funding to assistance continuing investigate and scientific studies in an exertion to establish protection and efficacy of electroporation technological know-how as a supply system or create feasible DNA medicines, our ability to assist our pipeline of DNA drugs goods, the capability of our collaborators to attain enhancement and professional milestones for products we license and merchandise gross sales that will permit us to get future payments and royalties, the adequacy of our cash sources, the availability or opportunity availability of different therapies or treatment plans for the conditions focused by us or collaborators, such as alternate options that could be far more efficacious or expense helpful than any therapy or cure that we and our collaborators hope to create, troubles involving merchandise liability, problems involving patents and irrespective of whether they or licenses to them will offer us with meaningful safety from other people using the covered technologies, no matter whether these proprietary rights are enforceable or defensible or infringe or allegedly infringe on legal rights of other individuals or can endure promises of invalidity and no matter whether we can finance or commit other substantial methods that may perhaps be essential to prosecute, defend or protect them, the amount of corporate expenses, assessments of our know-how by probable company or other partners or collaborators, capital industry problems, the affect of authorities healthcare proposals and other variables established forth in our Once-a-year Report on Sort 10-K for the 12 months ended December 31, 2020 and other filings we make from time to time with the Securities and Trade Commission. There can be no assurance that any merchandise prospect in our pipeline will be efficiently made, produced or commercialized, that closing final results of medical trials will be supportive of regulatory approvals essential to industry products, or that any of the forward-hunting details offered herein will be tested exact. Ahead-seeking statements communicate only as of the date of this launch, and we undertake no obligation to update or revise these statements, except as may perhaps be expected by legislation.

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Source INOVIO Prescription drugs, Inc.