EnGeneIC says it has developed a unique nano cellular technology that in pre-clinical animal studies has been shown to stimulate a broad and powerful anti-COVID-19 immune response.
The company said it also neutralises the known mutant COVID-19 viruses of concern, including the delta variant.
EnGeneIC has commenced a Phase 1 clinical trial dosing healthy adults at St Vincent’s Hospital in Melbourne using its patented nano cell technology platform (EnGeneIC Dream Vector - EDV). The trial is testing for safety and a plethora of anti-COVID-19 immune responses.
The company said EDVs have been packaged with three molecules. This includes one that produces the COVID-19 virus spike protein in the EDV nano cell, thereby stimulating a strong antibody response, a second that simultaneously triggers the activation of cells of the immune system that are involved in virus-fighting, and a third molecule that transforms the anti-virus antibody response into 'high affinity' antibodies.
It said the existing COVID-19-EDV already shows high neutralising antibody levels in pre-clinical animal studies against the variants of concern and can neutralise the delta variant at more than 95 per cent.
Dr Jennifer MacDiarmid and Dr Himanshu Brahmbhatt, who are co-CEOs of EnGeneIC, said this approach to COVID-19 became obvious to them since patients with late-stage cancer in the company’s current cancer clinical trials have responded to EDV treatment with the development of a robust immune response even though they have a severely compromised immune system.
“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. People with cancer, auto-immune diseases, chronic diseases, or even older individuals have a degree of immune-deficiency and are not likely to respond effectively to current vaccines," they said.
"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.”
The company said the COVID-19-EDV is designed as a vaccine for people who are particularly vulnerable to COVID-19 because they have compromised immune systems and may not respond effectively to existing vaccines.
A US-based hospital network is working with EnGeneIC to expedite a clinical trial to test the COVID-19-EDV in this same immune-compromised group.
EnGeneIC said its COVID-19-EDV vaccine has the additional benefit of being stored at room temperature and currently has a shelf life of over three years.