INO-4800 COVID-19 Vaccine Description
INO-4800 is a DNA vaccine candidate matched to the novel coronavirus SARS-CoV-2, which causes the COVID-19 in humans. The INO-4800 vaccine contains the plasmid pGX9501, which encodes for the entire length of the Spike glycoprotein of SARS-CoV-2.
INOVIO's INO-4800 is a nucleic-acid-based vaccine found stable at room temperature for more than a year and does not require frozen transport or for years of storage, which are essential factors when implementing mass immunizations to battle the current pandemic, says INOVIO.
Inovio's proprietary platform hand-held smart device called CELLECTRA® leads the way forward for activation immunotherapy. CELLECTRA uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter. This one-of-a-kind platform delivers optimized DNA into cells, translated into proteins that activate an individual's immune system to generate a robust, targeted T cell and antibody response. Once inside the cell, the plasmids begin replicating, strengthening the body's own natural response mechanisms.
INOVIO's DNA medicine platform's advantages are how fast DNA medicines can be designed and manufactured, the stability of the products that do not require freezing in storage and transport, and the robust immune response, safety profile, and tolerability demonstrated in clinical trials. In addition, Inovio aims 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. Thus, this approach has the potential to develop in vivo production of therapeutic antibodies.
DNA medicines are composed of optimized DNA plasmids, small circles of double-stranded DNA synthesized or reorganized by a computer sequencing technology designed to produce a specific immune response in the body. INOVIO states, 'DNA medicines do not interfere with or change in any way an individual's DNA.'
Inovio clinical trials for INO-4800 are listed here.
INO-4800 COVID-19 Vaccine History
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 further translational study.
On July 29, 2020, bioRxiv published a non-peer-reviewed study that showed INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then was challenged with the live virus 13-weeks after the second dose (study week 17).
On October 8, 2020, npj Vaccines published an article titled "Experimental and in silico evidence suggests vaccines are unlikely to be affected by D614G mutation in SARS-CoV-2 spike protein." Researchers at the Commonwealth Scientific and Industrial Research Organization (CSIRO), Australia's national science research agency, and INOVIO reported that INO-4800 vaccination in a preclinical model was able to neutralize SARS-CoV-2 viruses with 'D614G' mutation (Aspartate-to-Glycine change at position 614) of the spike protein, which has become the dominant variant in the global COVID-19 pandemic.
On November 14, 2020, the Company stated the planned Phase 2/3 clinical trial, called INNOVATE, is a randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800 conducted in adults in the U.S. The INNOVATE trial will be funded by the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency.
The Lancet published a paper on December 23, 2020, that concluded 'INO-4800 demonstrated excellent safety and tolerability and was immunogenic in 100% (38/38) of the vaccinated subjects by eliciting either or both humoral or cellular immune responses.'
INOVIO announced on January 4, 2021, it entered into a collaboration and license agreement for INO-4800 with Advaccine, who will have the exclusive right to develop, manufacture, and commercialize INO-4800 within Greater China, which includes Mainland China, Hong Kong, Macao, and Taiwan. In addition, Advaccine will license its plasmid manufacturing process for use with INO-4800 and other INOVIO pipeline product candidates to INOVIO with the right to sublicense to INOVIO's manufacturing partners.
On April 14, 2021, the study entitled "INO-4800 DNA Vaccine Induces Neutralizing Antibodies and T cell Activity Against Global SARS-CoV-2 Variants" was submitted for peer review.
Dr. J. Joseph Kim, President and CEO of INOVIO, said in a press statement issued on August 26, 2021, "INOVIO's focus on supporting the global response to the pandemic is unwavering – and will bring forward the potential advantages of INO-4800, which in addition to being well-tolerated with balanced neutralizing antibodies and T cell responses (CD8 and CD4), has a strong thermostability profile, and potentially offers the ability to serve as both a primary as well as a booster vaccine."
Plymouth Meeting, PA-based INOVIO (NASDAQ: INO), is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to protect and treat people from infectious diseases. INOVIO's DNA medicines are transient and do not interfere with or change in any way an individual's DNA.
INO-4800 COVID-19 Vaccine Indication
INO-4800 is a DNA vaccine candidate designed to prevent the SARS-CoV-2 betacoronavirus from infecting humans, which causes COVID-19.
INO-4800 COVID-19 Vaccine Dosage
The Phase 2 segment of the trial is designed to evaluate the safety, tolerability, and immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg), in 3-to-1 randomization to receive either INO-4800 or placebo for each dose to confirm the more appropriate amount (s) for each of three age groups with high risks of infection (18-50 years, 51-64 years and 65 years and older) for the subsequent Phase 3 efficacy evaluation. The Company reported that both 1.0 mg and 2.0 mg dose groups demonstrated seroconversion in 95% of the subjects, with 78% showing neutralizing antibodies in the 1.0 mg dose group and 84% showing neutralizing antibodies in the 2.0 mg dose group.
INO-4802 Pan-COVID-19 Vaccine Candidate
On May 12, 2021, the Company announced that its next-generation Pan-COVID-19 vaccine candidate, INO-4802, induced potent neutralizing antibodies and T cell responses against the original Wuhan strain as well as against B.1.1.7 (U.K. variant), B.1.351 (South African variant), and P.1. (Brazilian variant) in preclinical models. These results demonstrate the potential of INOVIO's Pan-COVID-19 vaccine to induce cross-reactive immune responses against current and emerging viral variants as either a first-line vaccine or potentially as a boost for individuals previously immunized with various Wuhan-matched vaccines.
INO-4800 COVID-19 Vaccine News
November 10, 2021 - The Fool published: Inovio Pharmaceuticals Q3 2021 Earnings Call Transcript.
November 9, 2021 - INOVIO Receives U.S. FDA Authorization to Proceed with INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S. INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to conduct the INNOVATE Phase 3 segment in multiple countries in the Americas, Asia, and Africa.
November 5, 2021 - INOVIO announced effective immediately, four experienced and talented leaders will all join the executive team and report to INOVIO's President and CEO, Dr. J. Joseph Kim.
November 3, 2021 - INOVIO announced that it has received authorization from India's Central Drugs Standard Control Organization Drug Controller General of India to proceed with the Phase 3 segment of INOVIO's global Phase 2/3 trial, INNOVATE, in India for INO-4800, its DNA vaccine candidate for COVID-19. INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to conduct the INNOVATE Phase 3 segment in multiple countries in Latin America, Asia, and Africa. Regulatory authorization in India follows authorizations from health authorities in Brazil, the Philippines, Mexico, and Colombia.
October 27, 2021 - INOVIO announced today that third-quarter 2021 financial results will be released after the market closes on November 9, 2021. Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company's global Phase 3 efficacy trial (INNOVATE) involving its COVID-19 vaccine candidate, INO-4800.
October 26, 2021 - The WHO and the Ministries of Health of Colombia, Mali, and the Philippines announced the co-sponsored Solidarity Trial Vaccines launch. The Company's DNA vaccine encoding the spike protein was invited to participate.
October 21, 2021 - INOVIO announced the signing of a non-binding memorandum of understanding with Colombia's Ministry of Health and Social Protection, reflecting the intent to advance efforts to combat the pandemic and endemic threat posed by COVID-19 and to better prepare for future public health emergencies. The framework of the planned collaboration builds on INOVIO's recently announced authorization to proceed in Colombia with the Phase 3 segment of its global Phase 2/3 clinical trial, INNOVATE, for INO-4800, the Company's DNA vaccine candidate for COVID-19. In addition, INOVIO is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. on the INNOVATE Phase 3 segment in multiple countries. INOVIO previously announced approvals to conduct the trial in Brazil, the Philippines, and Mexico.
October 11, 2021 - INOVIO announced that it had received authorization from Colombia's Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or the National Food and Drug Surveillance Institute, to conduct the Phase 3 segment of INOVIO's global Phase 2/3 trial, INNOVATE in Colombia, for the INO-4800 vaccine candidate. INOVIO is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. on the INNOVATE Phase 3 segment in multiple countries, focusing on Latin America, Asia, and Africa. In addition, INOVIO recently announced that it had received regulatory authorization to proceed in Brazil, the Philippines, and Mexico.
September 22, 2021 - INOVIO announced that it had received authorization from Comisión Federal para la Protección contra Riesgos Sanitarios, the national health regulatory agency of Mexico, to conduct a clinical trial in that country as part of the Phase 3 segment of INOVIO's global Phase 2/3 trial, INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), for its DNA vaccine candidate for COVID-19, INO-4800.
August 26, 2021 - INOVIO announced that it had received regulatory authorization from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA), the national health regulatory agency of Brazil, to initiate the global Phase 3 segment of its Phase 2/3 trial, INNOVATE for INO-4800, its DNA vaccine candidate for COVID-19. As a result, INOVIO plans to conduct the global INNOVATE Phase 3 segment in multiple countries, including Brazil, with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd.
August 9, 2021 - INOVIO announced that it had received a regulatory allowance for two clinical trials investigating heterologous boosting with INO-4800 through its partner and trial-sponsor Advaccine Biopharmaceuticals Suzhou Co., Ltd., together with Sinovac Biotechnology. The studies will evaluate the safety, tolerability, and immunogenicity of heterologous prime-boost sequential immunizations using INO-4800 and CoronaVac®, an inactivated COVID-19 vaccine developed by Sinovac. In addition, recent analysis using clinical samples showed that INO-4800 maintained a robust T cell level against the delta variant when compared to T-cell responses from the original wildtype strain, further demonstrating INO-4800's ability to generate CD8 T cells, which INOVIO believes will be crucial in mitigating against rising variants such as delta.
July 26, 2021 - INOVIO announced that second-quarter 2021 financial results would be released after the market closes on August 9, 2021.
June 23, 2021 - The journal Vaccine published a new study: One or two-dose regimen of the SARS-CoV-2 synthetic DNA vaccine INO-4800 protects against respiratory tract disease burden in a nonhuman primate challenge model. Findings: Single and two-dose vaccination regimens were evaluated. Vaccination induced both binding and neutralizing antibodies, along with IFN-γ-producing T cells against SARS-CoV-2. Upon administration of a high viral dose (5 × 106 pfu) via the intranasal and intratracheal routes, we observed significantly reduced virus load in the lung and throat in the vaccinated animals compared to controls. 2 doses of INO-4800 was associated with more robust vaccine-induced immune responses and improved viral protection. Importantly, histopathological examination of lung tissue provided no indication of vaccine-enhanced disease following the SARS-CoV-2 challenge in INO-4800 immunized animals.
June 8, 2021 - INOVIO announced an expansion of its previously announced partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 trial INNOVATE. Together, the companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in two-to-one randomization in subjects 18 years and older across several countries, primarily in Latin America and Asia. The 2.0 mg dose was selected from the Phase 2 segment, where INO-4800 was shown to be generally well-tolerated and immunogenic in all tested age groups.
May 10, 2021 - INOVIO announced preliminary positive safety, tolerability, and immunogenicity data from its placebo-controlled and blinded Phase 2 segment of its Phase 2/3 clinical trial in the U.S., called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), evaluating INO-4800, its DNA vaccine candidate for COVID-19. INOVIO plans to file preliminary Phase 2 results and device data with the U.S. FDA. Following the submission and FDA concurrence, the Company plans to conduct a global Phase 3 clinical trial for INO-4800.
May 4, 2021 - INOVIO announced that management would present at the following virtual investor conferences in May 2021: Bank of America Merrill Lynch Health Care Conference and RBC Global Healthcare Conference.
April 23, 2021 - INOVIO announced that it is planning for a predominantly ex-U.S. Phase 3 trial for its COVID-19 vaccine candidate, INO-4800. Given the increasing availability of vaccines authorized for emergency use, the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency, will discontinue funding for the Phase 3 segment of the INNOVATE trial, while continuing to fund the completion of the ongoing Phase 2 segment.
April 15, 2021 - INOVIO announced the results of a study focusing on the human immune responses induced by INOVIO's DNA vaccine candidate for COVID-19, INO-4800, against variants of concern. The results showed that INO-4800 induced a robust T cell response against all spike protein variants tested. The Company believes will be key in providing protection against SARS-CoV-2 variants and providing similar levels of neutralizing activity against both the U.K. and Brazilian variants as those against the original strain. Dr. J. Joseph Kim, INOVIO's President & CEO, said, "These results are consistent with our expectation that INO-4800, which was found to be well-tolerated and able to produce a balanced immune response in our Phase 1 trial, can generate both neutralizing antibodies and robust T cell responses – both of which will be essential to protect against the emerging variants of concern."
March 1, 2021 - INOVIO reported financial results for the quarter ended December 31, 2020, including vaccine development news. INOVIO's net loss for the quarter and year ended December 31, 2020, was $24.3 million, or $0.14 per basic and diluted share, and $166.4 million, or $1.07 per basic and diluted share, respectively, compared to a net loss of $37.7 million, or $0.38 per basic and diluted share, and $119.4 million, or $1.21 per basic and diluted share, for the quarter and year ended December 31, 2019, respectively. In first-quarter 2021, INOVIO enrolled 400 subjects in the Phase 2 segment of the INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) Phase 2/3 clinical trial. In addition, INOVIO addresses the new COVID variants by evaluating the impact of newly circulating strains of the SARS-CoV-2 virus on the immune profile of the INO-4800 vaccine and developing next-generation, pan-COVID vaccine candidates whose design could potentially provide better protection against the known and currently unknown SARS-CoV-2 variants.
February 2, 2021 - Industry press release: High COVID-19 Vaccine Uptake Proving Critical for Achieving Individual and Population Immunity.
January 26, 2021 - Local media reported in documents filed with the Securities and Exchange Commission, Inovio stated it plans to use the $162 million in net proceeds from the stock sale primarily to advance the development of its clinical pipeline, including clinical development expenses relating to INO-4800, the Company's Covid-19 vaccine candidate.
January 20, 2021 - INOVIO Pharmaceuticals, Inc. announced the pricing of an underwritten public offering of 17,700,000 shares of its common stock at a public offering. Gross proceeds to INOVIO from the offering are expected to be approximately $150.5 million before deducting underwriting discounts and commissions and estimated offering expenses, but excluding any exercise of the underwriters' option.
January 4, 2021 - INOVIO and Advaccine Biopharmaceuticals Suzhou Co., Ltd. announced that they have entered into a collaboration and license agreement for COVID-19 DNA vaccine candidate INO-4800, which has the exclusive right to develop, manufacture and commercialize INO-4800 within Greater China, inclusive of Mainland China, Hong Kong, Macao, and Taiwan.
January 2021 - Inovio's Powering a New Decade of DNA Medicines January 2021' presentation.
December 24, 2020 - INOVIO announced peer-reviewed Phase 1 clinical data from the first cohort of 40 participants for its COVID-19 DNA vaccine candidate, INO-4800, in EClinicalMedicine.
December 7, 2020 - INOVIO announced it had dosed its first subject in Phase 2 clinical trial evaluating DNA medicine INO-4800, as part of its Phase 2/3 clinical trial, called INNOVATE.
December 3, 2020 - INOVIO announced the execution of an agreement with Kaneka Eurogentec S.A., an affiliate of Kaneka Corporation, for Eurogentec to manufacture INOVIO's COVID-19 vaccine candidate INO-4800 at their industry-leading GMP plasmid production scales. Kaneka Eurogentec joins existing partners Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Biosciences in INOVIO's global manufacturing consortium.
November 16, 2020 - INOVIO announced that it had received clearance from the U.S. FDA to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800 its COVID-19 vaccine candidate.
September 28, 2020 - INOVIO announced that the U.S. FDA had notified the Company it has additional questions about its planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the study.
September 8, 2020 - INOVIO announced that Thermo Fisher Scientific had signed a letter of intent to manufacture INOVIO's DNA COVID-19 vaccine candidate INO-4800. With its consortium of third-party manufacturers, INOVIO plans to have 100 million doses of INO-4800 manufactured in 2021, subject to FDA approval of INO-4800 for use as a COVID-19 vaccine. Thermo Fisher Scientific will join existing partners Richter-Helm BioLogics and Ology Biosciences in INOVIO's global manufacturing consortium.
July 30, 2020 - Published on the non-peer-reviewed online preprint site bioRxiv, INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then were challenged with the live virus 13 weeks after the second dose (study week 17). The reduced viral loads following exposure to SARS-CoV-2 infection at this timeframe demonstrate a meaningful, durable impact mediated by INO-4800. In addition, this is the first time vaccine protection in nonhuman primates was reported from memory immune responses. Previously reported monkey vaccine challenge studies were conducted near their peak immune responses (1-4 weeks from their last vaccination).
July 15, 2020 - Seoul National University Hospital said that it had administered the first dose of INO-4800, Inovio's Covid-19 vaccine, to a patient in his 40s.
June 30, 2020 - INOVIO announced positive interim clinical data of its vaccine candidate against novel coronavirus (SARS-CoV-2) from the first two Phase 1 clinical trial cohorts. Also, INO-4800 has been selected to participate in a nonhuman primate challenge study as part of the U.S. government's Operation Warp Speed. Furthermore, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial this summer upon regulatory concurrence.
June 23, 2020 - INOVIO announced it had received $71 million funding from the U.S. DoD to support the large-scale manufacture of the Company's proprietary CELLECTRA® 3PSP smart device and the procurement of CELLECTRA® 2000 devices, which are used to deliver the INO-4800 vaccine candidate directly into the skin, where the vaccine prompts the body's immune system to drive a robust immune response.
June 4, 2020 - INOVIO and Seoul National University Hospital announced a partnership to start a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine INO-4800 in South Korea.
June 3, 2020 - Inovio Pharmaceuticals, Inc. filed a complaint in the Court of Common Pleas of Montgomery County, Pennsylvania, seeking, among other requests for emergency relief, to compel VGXI, Inc. and GeneOne Life Science, Inc. to facilitate the transfer of manufacturing methods, using VGXI's technology, under the parties' existing supply agreement.
April 30, 2020 - INOVIO announced it has agreed 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. The agreement is partly funded by an initial grant of $1.3 million from the Coalition for Epidemic Preparedness Innovations (CEPI), bringing CEPI's total support to date for developing INO-4800 to $17.2 million.
April 16, 2020 - The International Vaccine Institute (IVI) announced that the Coalition for Epidemic Preparedness Innovations had 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.
April 6, 2020 - INOVIO Pharmaceuticals, Inc. announced that the U.S. FDA had accepted its Investigational New Drug application for INO-4800, its DNA vaccine candidate.
March 12, 2020 - INOVIO Pharmaceuticals, Inc. announced that it had received a $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.
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 impacts 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 would support Inovio's preclinical and clinical development through Phase 1 human testing of INO-4800, its new coronavirus vaccine candidate.
INOVIO Collaborators and Partners
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.
INO-4800 COVID-19 Vaccine Clinical Trials
INOVIO has assembled a global coalition of collaborators, partners, and funders to rapidly advance the development of INO-4800. R&D collaborators include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University, and Laval University.
ClinicalTrials.gov Identifier: NCT04642638 - Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure.