The Ii-Key vaccine is designed to be a complete vaccine, Bintai Kinden said. The technology offers the safest and best route for the rapid development of a Covid-19 vaccine that can be safely administered to everyone, including adolescents, children and pregnant women without worry of immune related side effects.
A complete vaccine is designed to regulate the immune system to provide a targeted,
neutralising antibody response without generating off-target, non-neutralising antibodies that can lead to antibody dependent enhancement of disease; further a complete vaccine should activate the appropriate T cell responses to yield long-term immune memory without activating detrimental Th2 responses that have been associated with immune-related complications of Covid-19 disease.
On the progress and development of Generex’s Covid-19 vaccine, Bintai Kinden managing director Ong Choon Lui said based on the results of the ex-vivo human studies, Generex has initiated good manufacturing practice production of several Covid-19 epitopes that will be formulated for Phase I and Phase II clinical trials; an investigational new drug application is being prepared for Food and Drug Administration submission in early 2021.
“With multiple epitopes that are targeted to generate specific, neutralising regions of the coronavirus without off-target effects, and which have demonstrated positive T cell regulation necessary for long-term immune memory, the Covid-19 vaccine has the potential to be a complete vaccine,” he said in a statement.
Meanwhile, Generex’s subsidiary NuGenerex Immuno-Oncology Inc is exploring additional opportunities to deploy the targeted Covid-19 vaccine as a universal booster for RNA, DNA, and inactivated virus vaccines that contain the entire spike protein and have the potential to elicit off-target and overactive immune responses.