Inovio’s COVID-19 vaccine shows encouraging early results, joins Trump’s ‘Warp Speed’  |  Photo Credit: iStock Images
- INO-4800 is Inovio’s DNA vaccine being developed to protect against the novel coronavirus
- Results from early trial show the vaccine was generally safe and well-tolerated in all participants
- At least 23 COVID-19 vaccine projects have so far launched clinical trials on humans
Plymouth Meeting, Pa: Inovio Pharmaceuticals, a US biotech firm, on Tuesday reported that its experimental vaccine against the novel coronavirus (SARS-CoV-2) has shown encouraging results in a small preliminary trial. The firm claimed that its INO-4800, a DNA vaccine against COVID-19, triggered an immune response in 94 per cent of volunteers who completed the phase 1 clinical trial. Inovio now plans to initiate a Phase 2/3 trial to assess the efficacy of the vaccine this summer upon regulatory concurrence.
In a press release, Inovio also said that its INO-4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the US government’s Operation Warp Speed, a new national program aiming to produce hundreds of millions of safe, effective doses of the vaccine for Americans by January 2021. The firm has expanded its Phase 1 trial to add older participants in additional cohorts.
Inovio’s INO-4800 vaccine was designed rapidly to precisely match the DNA sequence of the SARS-CoV-2 virus, which causes COVID-19. The vaccine is patterned to inject DNA into a person so as to set off a specific immune system response against the novel coronavirus. The medication is injected under the skin using a needle, then activated with a device that resembles a toothbrush to deliver an electrical impulse for a fraction of a second, allowing the DNA to penetrate the body’s cells and carry out its mission, reported AFP.
In the phase 1 clinical trial, Inovio scientists administered the vaccine to 40 healthy adult volunteers between 18 to 50 years of age at two US sites, with each participant receiving two doses of INO-4800 four weeks apart. The participants were enrolled into 1.0 mg and 2.0 mg dose cohorts.
Results from the trial showed that the INO-4800 COVID-19 vaccine was generally safe and well-tolerated in all participants in both cohorts through week 8. As per the company, no serious adverse events (SAEs) were reported and all 10 participants who experienced adverse events (AEs) were grade 1 in severity, and most were local injection site redness.
Inovio’s INO-4800 has also been shown to protect mice in the new coronavirus viral challenge studies, where vaccination with the jab prevented viral replication in the lungs of animals challenged with SARS-CoV-2.
CEO Joseph Kim said that Inovio’s medication is the only DNA vaccine that is stable at room temperature for more than a year and does not need refrigeration for transport or storage for several years, which are important factors when implementing mass immunizations.
Inovio, which is a leader in coronavirus DNA vaccine development, is financed by the US Defense Department and the NGO CEPI. The company said it is expediting the development of INO-4800 COVID-19 vaccine and is planning to have 1 million doses of the vaccine by the end of 2020.
According to the London School of Hygiene & Tropical Medicine, currently, a total of 23 COVID-19 vaccine projects have launched clinical trials on humans, with several candidates already in phase 2 or 3 trials. Moderna’s mRNA vaccine and Oxford-AstraZeneca’s AZD1222 candidate are among those which are in the most advanced stages of development. Several Chinese companies are also at the forefront of efforts to create a safe vaccine against COVID-19. Recently, China’s CanSinoBIO announced that it has received permission to administer its COVID-19 vaccine to the Chinese military for a year.
The novel coronavirus has now killed at least 506,818 people worldwide, and as many as 10,372,230 cases have been registered in 196 countries and territories.