INO-4800 DNA Vaccine Description
INO-4800 is a DNA vaccine candidate matched to the novel coronavirus SARS-CoV-2, which causes the COVID-19 disease in humans. Inovio's proprietary platform hand-held smart device called CELLECTRA® is leading the way forward for activation immunotherapy.
This one-of-a-kind platform delivers optimized DNA into cells, where it is translated into proteins that activate an individual's immune system to generate a robust targeted T cell and antibody response. CELLECTRA uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter. Once inside the cell, the plasmids begin replicating, thereby strengthening the body's own natural response mechanisms.
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 is aiming to significantly expand the therapeutic range of monoclonal antibodies with its DNA-encoded monoclonal antibody technology. With dMAb, Inovio encodes DNA to express a monoclonal antibody. Injection of the DNA plasmid into a patient generates robust in vivo monoclonal antibody production.
This approach has the potential to generate in vivo production of therapeutic antibodies. Inovio's DNA medicines are not interfering with or changing in any way an individual's own DNA.
Published in Nature Communications on May 20, 2020, a new report focuses on immune studies in animals, which show induction of functional antibody responses and T-cell responses following immunization. This preliminary dataset identifies INO-4800 as a potential COVID-19 vaccine candidate, supporting the further translational study.
"Producing a COVID-19 vaccine within the next 12 to 18 months is not only a scientific challenge; it will also require new levels of collaboration and investment across industry and government. There is still a long road ahead before we have a safe, effective, and globally accessible vaccine ready for broader use, but today we have reached an important milestone on that journey," stated the company's press release.
INO-4800 DNA Vaccine Indication
INO-4800 is a DNA vaccine candidate designed to prevent novel coronavirus SARS-CoV-2 from infecting humans, which causes COVID-19 disease.
INO-4800 DNA Vaccine Dosage
Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit. INO-4800 will be administered ID on Day 0 and Week 4. EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Week 4.
INO-4800 DNA Vaccine Development News
- May 20, 2020 - The Wistar Institute announced a study reporting initial immunogenicity of a synthetic DNA vaccine for SARS-CoV-2 developed in collaboration with Inovio Pharmaceutical, Inc., and other scientists. Published in Nature Communications, the report focuses on immune studies in animals, which show induction of functional antibody responses and T-cell responses following immunization.
- May 11, 2020 - INOVIO's President and Chief Executive Officer Dr. J. Joseph Kim said U.S. Phase 1 clinical trial for COVID-19 vaccine candidate INO-4800 completed enrollment with 40 healthy volunteers; preliminary results expected in late June 2020. The Phase 2/3 efficacy trial for INO-4800 'to start this summer upon regulatory approval.'
- April 30, 2020 - INOVIO announced it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIO's investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. for COVID-19 and could potentially advance to Phase 2/3 efficacy trials this summer. The agreement is being partly funded by an initial grant of $1.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI), which brings CEPI's total support to date for the development of INO-4800 to $17.2 million.
- April 28, 2020 - INOVIO announced that its Phase 1 clinical trial for COVID-19 DNA vaccine INO-4800 is fully enrolled with all 40 healthy volunteers receiving their first dose, with interim immune responses and safety results expected in late June 2020. The 40 healthy volunteers now enrolled at sites at the University of Pennsylvania, and a clinic in Kansas City, MO, will receive 2-doses of INO-4800, four weeks apart. The Phase 1 study is designed to assess the safety profile and immunogenicity of INO-4800 in support of advancing rapidly to a Phase 2/3 efficacy trial, which is planned to potentially initiate this summer.
- April 16, 2020 - The International Vaccine Institute (IVI) announced that the Coalition for Epidemic Preparedness Innovations has granted $6.9 million funding to INOVIO to work with IVI and the Korea National Institute of Health (KNIH) for a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine candidate (INO-4800) in South Korea. IVI will conduct the trial in parallel to INOVIO's Phase 1 INO-4800 study currently underway in the US since April 6, 2020, with 40 healthy adults receiving the vaccine candidate and eventually expanding to older adults.
- April 6, 2020 - INOVIO Pharmaceuticals, Inc. announced that the U.S. FDA has accepted the company's Investigational New Drug application for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in healthy volunteers beginning this week. The first dosing is planned for today.
- March 24, 2020 - Ology Bioservices Inc. and Inovio Pharmaceuticals Inc. announced today that the US DOD has awarded Ology Bioservices with a contract valued at $11.9 million to work with Inovio on DNA technology transfer to rapidly manufacture DNA vaccines such as (INO-4800).
- March 12, 2020 - INOVIO Pharmaceuticals, Inc. announced that it has received a new $5 million grant from the Bill & Melinda Gates Foundation to accelerate the testing and scale-up of CELLECTRA® 3PSP proprietary smart device for the intradermal delivery of INO-4800, a DNA vaccine for COVID-19 disease. Inovio said its Cellectra 3PSP device is a small, hand-held and portable device that runs on AA batteries and can be used to inject a vaccine. It was originally developed using $8.1 million in funding from the medical arm of the U.S. Defense Threat Reduction Agency’s Medical CBRN Defense Consortium. Inovio reiterated that it expects to deliver 1 million doses of INO-4800 by year-end 2020.
- March 3, 2020 - Inovio Pharmaceuticals, Inc. announced an accelerated timeline for developing its DNA vaccine INO-4800. We plan to begin human clinical trials in the U.S. in April and soon thereafter in China and South Korea, where the outbreak is impacting the most people. We plan on delivering one million doses by year-end 2020 with existing resources and capacity.
- January 30, 2020, Beijing Advaccine Biotechnology announced a collaboration with Inovio Pharmaceuticals, Inc. to advance the development in China of the INO-4800 vaccine candidate, which is targeted against the novel coronavirus named 2019-nCoV.
- January 23, 2020, Inovio Pharmaceuticals, Inc. said in a press release that the Coalition for Epidemic Preparedness Innovations funding of $9 million dollars will support Inovio's preclinical and clinical development through Phase 1 human testing of INO-4800, its new coronavirus vaccine candidate matched to the outbreak strain. Inovio's collaborators for this coronavirus vaccine development include the Wistar Institute, VGXI, a fully owned subsidiary of GeneOne Life Science, and Twist Bioscience.
INO-4800 DNA Vaccine Clinical Trial Information
ClinicalTrials.gov Identifier: NCT04336410
April 2020 - Human clinical trials begin with 40 healthy adult volunteers in Philadelphia, PA (University of Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research), where screening of potential participants has already begun. This is an open-label trial to evaluate the safety, tolerability, and immunological profile of INO-4800 administered by intradermal injection followed by electroporation using CELLECTRA® 2000 device in healthy adult volunteers.
Each participant will receive 2-doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer.
Preliminary results expected in late June 2020.
The Phase 2/3 efficacy trial for INO-4800 'to start this summer upon regulatory approval.'