By TMR / Pic BERNAMA
BINTAI Kinden Corp Bhd’s partner Generex Biotechnology Corp has filed for a trademark for its li-Key vaccine as The Complete VaccineTM and patent for its li-Key-SARS-CoV-2 vaccine.
The li-Key vaccine is designed to be a complete 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,” the company said in a statement yesterday.
On the progress and development of Generex’s Covid-19 vaccine, Bintai Kinden MD Ong Choon Lui said, according to the announcement of Generex, 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 added.
It has been widely reported the Covid-19 virus, like all viruses, is mutating.
Some of the mutational variants, with mutations that mainly occur in the virus spike protein, appear to have biological dif- ferences that may alter infectivity, trans- mission and severity of infection. The li-Key vaccine platform is built to address issues of mutation.
First, there are multiple Covid-19 vaccine peptides, each containing multiple epitopes in the vaccine formulation. So even if there is one mutation, the other epitopes should provide protection.
Second, if a new strain emerges, the li-Key platform can be rapidly deployed to make the new, mutant sequence with li-Key and add it to the current vaccine. This is the beauty of the li-Key technology.
Further, the epitopes predicted by computational algorithms exclude regions of the coronavirus that are susceptible to mutation, so the li-Key vaccine largely eliminates mutagenic regions from the start.
With an impending investigational new drug submission for Phase I and II human clinical trials to evaluate safety and immunogenicity of the li-Key vaccine, 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 an off-target and overactive immune responses.
The targeted Covid-19 vaccine by Generex is designed to generate long-term immune memory through specific T-cell activation by the li-Key, and the antibody purification studies demonstrate the potential for the li-Key vaccine to elicit a targeted, neutralising immune response without off-target effects.
Bintai Healthcare Sdn Bhd, a subsidiary of Bintai Kinden, was granted the exclusive rights from Generex Biotechnology Corp and its subsidiary, NuGenerex Immuno-Oncology, to distribute, sell and commercialise the Covid-19 vaccine in Malaysia, Brunei, Myanmar, Cambodia, Timor-Leste, Indonesia, Laos, Philippines, Singapore, Thailand and Vietnam.