EnGeneIC has initiated dosing in Phase I clinical trial of its first-ever nanocellular technology-based anti-Covid-19 vaccine in healthy adults.
Named EnGeneIC Dream Vector (EDV), the nanocell technology platform was demonstrated to induce a wide-ranging and robust anti-Covid-19 immune response in pre-clinical animal studies.
It also showed the ability to neutralise the known mutant SARS-CoV-2 viruses of concern, especially the Delta variant, EnGeneIC noted.
The EDVs comprise three molecules, one that generates the SARS-CoV-2 Spike protein in the EDV nanocell and a second molecule that concurrently induces the activation of vital cells of the immune system associated with virus-fighting.
The third molecule can alter the anti-virus antibody response into increased affinity velcro-like antibodies that can kill the mutant viruses.
To date, two subjects in the Phase I trial were dosed at the St Vincent’s Hospital in Melbourne, Australia. The trial is intended to assess the vaccine’s safety and immune responses against Covid-19.
Immune readouts are anticipated to be reported at one and three months after dosing, the company noted.
EnGeneIC co-CEOs Dr Jennifer MacDiarmid and Dr Himanshu Brahmbhatt said: “We appreciate that the vaccine rollout is ongoing in Australia, but no vaccine to date is directed towards immune-compromised people and these people were excluded from vaccine trials aimed at obtaining emergency approval.
“Our cancer clinical trials show positive outcomes including improved anti-cancer immunity for those with end-stage cancers.
“These trials also show that our treatment is very safe since it does not harm healthy cells, and in fact, it is ground-breaking in that it results in activation of healthy white blood cells (immune cells) in these vulnerable patients.”
On concluding the safety trial, the vaccine is intended for use in vulnerable individuals with compromised immune systems and who may be unresponsive to currently available vaccines.
At present, the company is collaborating with a US-based hospital conglomerate to fast-track the trial in the country to assess the vaccine in immune-compromised individuals.
EnGeneIC noted that the COVID-19-EDV vaccine can be stored at room temperature with a shelf life of more than three years, aiding in easy transportation globally.