INOVIO’s COVID-19 DNA Vaccine INO-4800 Demonstrates Robust Neutralizing Antibody and T Cell Immune Responses in Preclinical Models

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Read the full publication in Nature Communications: DNA based vaccine against Covid 19

Source: WSJ

Publication in Nature Communications demonstrates generation of robust neutralizing antibodies and T cell responses against SARS-CoV-2

PLYMOUTH MEETING, Pa., May 20, 2020 /PRNewswire/ — INOVIO (NASDAQ:INO) today announced the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. The study was published in the peer-reviewed journal Nature Communications titled, “Immunogenicity of a DNA vaccine candidate for COVID-19” by INOVIO scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine.

Dr. Kate Broderick, INOVIO’s Senior Vice President of R&D and the Team Lead for COVID-19 vaccine development, said, “These positive preclinical results from our COVID-19 DNA vaccine (INO-4800) not only highlight the potency of our DNA medicines platform, but also build on our previously reported positive Phase 1/2a data from our vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from a similarly designed vaccine INO-4700. The potent neutralizing antibody and T cell immune responses generated in multiple animal models are supportive of our currently on-going INO-4800 clinical trials.”

INO-4800 targets the major surface antigen Spike protein of SARS-CoV-2 virus, which causes COVID-19 disease. The studies demonstrated that vaccination with INO-4800 generated robust binding and neutralizing antibody as well as T cell responses in mice and guinea pigs. Importantly, the authors demonstrated virus neutralizing activity using three separate neutralization assays testing the vaccine’s ability to generate antibodies which can block virus infection by: 1) an assay using live SARS-CoV-2 viruses; 2) an assay using a pseudo-virus assay, where another virus displays the SARS-CoV-2 Spike protein; and, 3) a novel high-throughput surrogate neutralization assay measuring the ability of INO-4800-induced antibodies to block SARS-CoV-2 Spike binding to the host ACE2 receptor. Study authors also detected these antibodies in the lungs of the vaccinated animals which could be important in providing protection from SARS-CoV-2. In addition, high levels of Spike-specific T cell responses were observed with INO-4800 vaccination, which could be important in mediating protection from the virus infection. Collectively, this preclinical dataset demonstrates that INO-4800 is a promising COVID-19 vaccine candidate against this emerging disease threat.

Dr. J. Joseph Kim, INOVIO’s President & CEO, said, “INOVIO and our collaborators are working diligently to advance INO-4800 to help fight the current pandemic. We are planning to utilize these positive preclinical results along with our upcoming animal challenge data and safety and immune responses data from our Phase 1 studies to support rapidly advancing this summer to a large, randomized Phase 2/3 clinical trial.”

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2 replies

  1. The race to develop a vaccine against COVID-19 is charging full speed ahead.

    Yesterday, Inovio Pharmaceuticals (INO) released promising preclinical data for the biotech’s COVID-19 DNA vaccine candidate, INO-4800. Investors have high hopes for the vaccine maker and have sent the stock soaring by over 332% so far this year.

    The results, published in Nature Communications, showed INO-4800 elicited strong binding and neutralizing antibody responses in addition to high-level T cell responses in mice and guinea pigs.

    INO-4800 targets the major antigen spike protein of the SARS-CoV-2 virus, which causes COVID-19, and is currently in a Phase 1 trial. 40 healthy volunteers are taking part, with interim data expected in June.

    With data in hand, Inovio will approach the FDA for authorization to move forward with a Phase 2/3 trial, which it hopes to initiate in July or August. The company expects to recruit 2,000 frontline healthcare workers for the Phase 2/3 study.

    “We believe data from this randomized trial, if positive, could allow the company to file for emergency regulatory approval for INO-4800,” said H.C. Wainwright’s Ram Selvaraju.

    Additionally, Inovio will examine the vaccine in larger animals including rabbits and monkeys. The company will conduct “challenge” studies, which involve giving the virus to an animal and then seeing if the vaccine prevents the infection.

  2. The gradual relaxation of coronavirus restrictions is stoking hopes for an economic rebound, with the biotechnology industry riding a wave of expectations in the hunt for an effective COVID-19 treatment.

    Vaccines are perceived as key to ending the restraints on work and life that have decimated the global economy, and returning to some sense of normalcy. Worldwide, there are nearly 5 million positive cases and over 300,000 have been killed by the virus.

    With so much at stake, the global pipeline has become an intense space race for the new era. Nations are locked in an intense effort to demonstrate their biotech capabilities in the worldwide fight against COVID-19.

    In collaboration with branches of the U.S. Health and Human Services (HHS) and National Institute of Health (NIH), small and large drug companies have been working on vaccines.

    For now, the furthest along are Moderna (MRNA) and Pfizer (PFE), both of which are using messenger RNA technology— a newer technology that doesn’t exist in the current drug market. Both have entered human clinical trials. Abroad, all eyes are on China’s CanSino, and a project underway at Oxford University in the U.K.

    Currently, “there are at least a hundred horses in the race, and we’ve got some leaders up front,” Marc Poznansky, the director of the Vaccine and Immunotherapy Center at Massachusetts General Hospital, told Yahoo Finance recently.

    He added that it was “unprecedented to have that many platforms at play putting a product into testing to try to get to first in human” trials.

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