With the study protocol approved by Israel's Institutional Review Board (IRB) at Ichilov Hospital, Oravax, a product of Oramed Pharmaceuticals, is set to begin clinical trials of its oral Covid-19 vaccine in the country.
The Israel pharmaceutical market has yet to grant the company permission to conduct the trial.
Oravax creates an oral version of vaccines that are currently only available via injection by making use of Oramed's protein oral delivery (POD) technology.
Three surface proteins of the SARS CoV-2 virus are targeted by Oravax's virus-like particle (VLP) vaccine technology, including proteins that are less susceptible to mutation. This may make it possible for the vaccine to be effective against both current and potential viral variants.
Additionally, the VLP platform technology is available for oral or intravenous administration.
The oral VLP Covid-19 vaccine is being developed by Oravax for use both as a stand-alone vaccine and as a booster for people who have already received the vaccine.
The business noted that experts, including those from the World Health Organization (WHO), anticipate that both the general population and those who are at risk will require booster doses.
Oravax intends to expand the vaccine's Israeli clinical trial to international research facilities. Preclinical trials of the vaccine are also being conducted against Covid-19 variants, including the Delta variant.
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The vaccine's GMP production is currently moving forward.
Nadav Kidron, CEO of Oramed Pharmaceuticals, stated that: Due to the fact that it targets three proteins rather than one, our vaccine is a particularly strong candidate for combating the evolving Covid-19 virus.
Oravax's VLP technology "could prove even more important in the effort to combat Covid" because "the Delta and other variants are proving to be a challenge to health administrators around the world."
In addition, in order to develop and market an injectable version of its VLP technology in India, Oravax out-licensed specific rights to Premas Biotech, an Indian company.
After marketing the injectable vaccine in India, Oravax is eligible to receive royalty payments from Premas as part of the agreement.
Kidron continued, We saw a clear benefit in out-licensing rights to the injectable version of Oravax in India, where there is an urgent need for vaccines. Oravax is focused on oral vaccines.
The injectable vaccine will be made, tested, and possibly sold by Premas in India, where the Covid-19 vaccine market is expected to reach more than $2.3 billion by 2027.