The vaccine candidate demonstrated neutralizing antibody and T cell immune response against the novel coronavirus.
Inovio has announced positive preclinical data for its SARS-CoV-2 DNA vaccine, IN0-4800. The vaccine candidate demonstrated neutralizing antibody and T cell immune response against the novel coronavirus.
The results were published by scientists from the company and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine.
The investigational vaccine targets the major surface antigen Spike protein of SARS-CoV-2. Vaccination resulted in T cell responses in mice and guinea pigs.
Investigators used 3 neutralization assays testing the vaccine's ability to generate antibodies which can block virus infection: an assay using live SARS-CoV-2 viruses, using a pseudo-virus assay where another virus displays the SARS-CoV-2 Spike protein, and a neutralization assay testing the ability of INO-4800-induced antibodies to block SARS-CoV-2 Spike binding to the host ACE2 receptor.
Investigators also detected antibodies in the lungs of vaccinated animals, a promising sign for protection from SARS-CoV-2.
"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,” said Kate Broderick, PhD, Inovio’s Lead for COVID-19 vaccine development.
The firm intends to build on these animal-model developments in the near future, in human clinical trials.
"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," J. Joseph Kim, PhD, Inovio’s President & CEO, said.
Inovio has previous experience advancing a DNA vaccine against MERS-CoV. The vaccine, INO-4700, is the only MERS-CoV vaccine demonstrating positive results in a Phas 1/2a clinical trial and the company is preparing to initiate a larger Phase 2 INO-4700 trial in the Middle East where most MERS viral outbreaks have occurred.
Preliminary safety and immune responses data from the Phase 1 clinical trial are expected in June and further animal challenge study data are expected in the coming weeks. The Phase 2/3 efficacy trial is likely to begin between July and August with regulatory approval.
Just days ago, Moderna also announced positive preliminary results for its coronavirus vaccine candidate, mRNA-1273. Data were from the phase 1 study led by the National Institute of Allergy and Infectious Diseases. mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike protein. After 2 doses, across the 25 µg and 100 µg dose cohorts, mRNA-1273 triggered dose-dependent increases in immunogenicity.