EnGeneIC has started dosing in Phase I clinical trial of the world’s first nanocellular technology-based anti-Covid-19 vaccine in healthy adults.
Referred to as EnGeneIC Dream Vector (EDV), the nanocell technology platform was observed to trigger a wide and robust immune response against Covid-19 in pre-clinical animal studies.
It also demonstrated the ability to neutralise the identified mutant SARS-CoV-2 viruses of concern, mainly the Delta variant.
The EDVs comprise a molecule that makes the SARS-CoV-2 Spike protein in the EDV nanocell and a second molecule that concurrently stimulates the activation of critical cells of the immune system associated with virus-fighting.
Meanwhile, a third molecule can alter the anti-virus antibody response into increased affinity velcro-like antibodies that can neutralise the mutant viruses.
The Phase I trial is designed to evaluate the new vaccine’s safety and immune responses against Covid-19. To date, two subjects in the study received dosing at the St Vincent’s Hospital in Melbourne, Australia.
Immune readouts are anticipated 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.”
After the safety trial, the vaccine is meant for use in vulnerable people with compromised immune systems and who may be unresponsive to currently available vaccines.
EnGeneIC is now collaborating with a US-based hospital conglomerate to accelerate the trial in the country to analyse the COVID-19-EDV vaccine in immune-compromised individuals.
The company added that the vaccine can be stored at room temperature with a shelf life of more than three years, aiding in easy transportation.