INO-4700 Vaccine Description 2022
The INO-4700 MERS-CoV product is a DNA vaccine candidate, allowing rapid design and production in response to emerging infectious diseases. Underscoring the potential for rapid deployment of DNA vaccines, INO-4700 was advanced into the clinic within nine months of preclinical vaccine candidate selection.
INO-4700 (GLS-5300) is a DNA plasmid vaccine that expresses the MERS-CoV spike (S) glycoprotein and was co-developed by GeneOne Life Science Inc. and Inovio Pharmaceuticals.
The completed Phase 1 study, the INO-4700 vaccine candidate, was found well-tolerated and induced high antibody responses in 95% of subjects while generating broad-based T cell responses in nearly 90% of study participants. In addition, durable antibody responses to INO-4700 used in that trial were maintained through 60 weeks following dosing.
Dr. J. Joseph Kim, President, and CEO of INOVIO said in a press statement issued on August 4, 2021, "We are pleased to collaborate with CEPI to combat one of the most virulent pathogens of the coronavirus family for which there is no approved vaccine. This advancement not only complements our late-stage efforts with COVID-19 but also represents an important milestone for INOVIO's infectious disease platform. We look forward to continuing our collaboration with CEPI and moving another step closer to providing patients with a safe and effective preventive vaccine against MERS."
INOVIO confirmed on March 1, 2022, it had dosed and completed enrollment for the first part (dose-finding stage) of the Phase 2 trial (192 participants) of INO-4700. The multi-center Phase 2 trial is a randomized, double-blinded, placebo-controlled trial designed to evaluate the safety, tolerability, and immunogenicity of INO-4700 in approximately 500 healthy adult participants. The trial is sponsored by INOVIO and fully funded by the CEPI, is being conducted at sites in Jordan, Lebanon, and Kenya, where MERS cases have been reported.
Pennslyvania-based INOVIO is a biotechnology company 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 and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response.
INO-4700 Vaccine Indication
Human beta coronaviruses such as MERS were first identified in the mid-1960s. The best-known coronaviruses are MERS-CoV and Severe Acute Respiratory Syndrome (SARS-CoV) and the 2019 Novel Coronavirus (SARS-CoV-2). From 2012 until July 2, 2021, the ECDC reported 2,591 MERS-CoV cases and 940 associated fatalities.
The INO-4700 vaccine is indicated to prevent MERS, a deadly viral respiratory disease caused by MERS-CoV infection. To date, there is no specific treatment proven effective against this viral disease. Also, no vaccine has been licensed to prevent MERS-CoV infection thus far. Overall, vaccine candidates against MERS-CoV are mainly based upon the viral spike (S) protein due to its vital role in the viral infectivity, although several studies focused on other viral proteins such as the nucleocapsid (N) protein, envelope (E) protein, and non-structural protein 16 (NSP16) have also been reported.
The majority of the identified MERS-CoV cases are nosocomially acquired via direct close contact with infected patients (Chowell et al., 2015; Cauchemez et al., 2016), whereas cases of zoonotic transmission from dromedary camels to humans were reported primarily in Saudi Arabia, where human-camel interaction is more frequent.
INO-4700 Vaccine Dosage
INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®.
A July 24, 2019, Phase 1 first-in-human clinical trial. Initial findings from the trial were published in The Lancet Infectious Diseases. The study, conducted at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center, evaluated a candidate DNA vaccine INO-4700.
Overall, for those receiving 0.6 mg of INO-4700, 88% demonstrated seroconversion after a 2 dose regimen at 0 and 8 weeks, while for those receiving a 3 dose regimen given at 0, 4, and 12 weeks, 84% seroconverted after 2 doses and 100% after 3 doses, as measured by a binding antibody assay against the full-length S protein (ELISA). Additionally, 92% of the vaccine recipients in both groups displayed the ability to neutralize the virus using a neutralization assay (EMC2012-Vero neutralization). Furthermore, robust T cell responses were observed in 60% of vaccine recipients after the 2 dose regimen and 84% in the 3 dose group (ELISpot assay). Interestingly, a single dose of 0.6 mg of INO-4700 intradermal vaccination resulted in a 74% binding antibody response rate and a 48% neutralization antibody response rate.
INO-4700 Vaccine News
August 4, 2021 - INOVIO announced that the company had dosed the initial Phase 2 trial subject in its quest to develop the first vaccine against the Middle East Respiratory Syndrome (MERS). INOVIO's Phase 2 trial is designed to evaluate INO-4700, its DNA vaccine candidate for the prevention of MERS, a disease in the coronavirus family for which there are no approved vaccines.
March 22, 2021 - This Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability, and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA™ 2000 device in healthy adult volunteers for the Middle East Respiratory Syndrome Coronavirus infection. This study is divided into 2 parts: Part 1- dose-finding stage and Part 2- dose expansion stage.
April 28, 2020 - INOVIO and GeneOne Life Science announced interim data through week 16 from a Phase 1/2a trial of DNA vaccine INO-4700 (also called GLS-5300) for MERS-CoV. Vaccine recipients demonstrated strong antibody and T cell immune responses after 2 or 3 doses with 0.6 mg of INO-4700. The vaccination regimen was well-tolerated with no vaccine-associated severe adverse events.
July 25, 2019 - Inovio Pharmaceuticals, Inc. announced positive results from the first-in-human trial of its vaccine against the MERS were published in The Lancet Infectious Diseases. This peer-reviewed article entitled, "Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: A phase 1, open-label, single-arm, dose-escalation trial," highlights clinical results of Inovio's collaborative vaccine study of INO-4700 (also called GLS-5300) against MERS delivered with the CELLECTRA® efficacy-enhancing device.
INO-4700 Vaccine Clinical Trials
Clinical Trial NCT04588428: Phase 2a Safety, Tolerability, and Immunogenicity of INO-4700 for MERS-CoV in 542 Healthy Volunteers. The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability, and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose-finding stage and Part 2- dose expansion stage. The multi-center Phase 2 trial is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of INO-4700 administered with INOVIO's smart device, the CELLECTRA® 2000, in approximately 500 healthy adult volunteers. The study, which is sponsored by INOVIO and fully funded by the Coalition for Epidemic Preparedness Innovations, is being conducted at sites in Jordan and Lebanon where MERS cases have been reported.
Clinical Trial NCT03721718: Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers. This Phase I/IIa study will evaluate the safety, tolerability, and immunogenicity of GLS-5300 administered intradermally (ID) followed by electroporation at 0.3 and 0.6 mg/dose assessing 2 and 3-dose regimens.
Clinical Trial NCT02670187: Phase I, Open-Label Dose-Ranging Safety Study of GLS-5300 in 60 Healthy Volunteers. The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe pulmonary infection in 2012.