Inovio has reported that results from a study of its DNA Covid-19 vaccine candidate INO-4800 showed it induced a robust T cell response in humans against all spike protein variants of concern.
INO-4800 has an optimised DNA plasmid and is provided directly into cells using a smart device to induce a strong and tolerable immune response.
Stable at room temperature for over a year and at 37°C for over a month, the vaccine has demonstrated a potential shelf life of five years at normal refrigeration temperature. It does not require freezing during transport or storage.
The study called ‘INO-4800 DNA Vaccine Induces Neutralizing Antibodies and T cell Activity Against Global SARS-CoV-2 Variants’ also shed light on INO-4800’s potential in offering strong levels of neutralising activity against the UK and Brazilian variants similar to those against the original strain.
Inovio president and CEO Dr J Joseph Kim 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 I trial, is able to generate both neutralising antibodies and robust T cell responses, both of which will be essential to protect against the emerging variants of concern.”
“We will report phase II results in 2Q, and, with FDA concurrence, expect to move into phase III in the second quarter of this year.”
For the study, clinical samples were obtained at different time points post-vaccination from subjects in the company’s phase I trial of INO-4800 in the US.
Antibodies capable of neutralising activity were assessed against the spike protein variants tested, including B.1.1.7 (UK variant), B.1.351 (South African variant) and P.1. (Brazilian variant).
According to the latest reports, mRNA or viral vector vaccines had a decreased neutralising activity against the Brazilian variant. Data from this study showed that INO-4800 induced strong neutralising antibodies at levels against Brazilian variant similar to those against the original strain.
In December last year, Inovio entered an agreement with Kaneka Eurogentec to manufacture INO-4800 at the latter’s leading GMP plasmid production scales.