Oramed Pharmaceuticals’s Oravax is set to initiate clinical trials of its oral Covid-19 vaccine in Israel with the study protocol approved by the Institutional Review Board (IRB) at Ichilov Hospital in the country.
The company is currently awaiting approval from the Israeli Ministry of Health for the trial.
Oravax leverages Oramed’s protein oral delivery (POD) technology to develop an oral version of vaccines that are currently available only via injection.
The virus-like particle (VLP) vaccine technology of Oravax acts on three surface proteins of the SARS CoV-2 virus, including proteins that are less prone to mutation. This could potentially enable the vaccine’s efficacy against existing and future viral variants.
Additionally, the VLP platform technology can be administered as an injection or orally.
Oravax is developing the oral VLP Covid-19 vaccine for use as a standalone vaccine and a booster for individuals who have already received Covid-19 vaccines.
The company noted that specialists, including at the World Health Organization (WHO), anticipate that booster doses will be required for the general population and those who are at risk.
Oravax intends to expand the Israeli clinical trial of the vaccine to global study centres. The vaccine is also being analysed in preclinical trials against Covid-19 variants including the Delta variant.
The GMP production for the vaccine is currently progressing.
Oramed Pharmaceuticals CEO Nadav Kidron said: “Our vaccine is a particularly strong candidate against the evolving Covid-19 virus due to its unique targeting of three proteins rather than one.
“With the Delta and other variants proving a challenge to health administrators globally, Oravax’s VLP technology could prove even more important in the effort to combat Covid.”
Furthermore, Oravax out-licensed specific rights to its VLP technology to an Indian firm, Premas Biotech, to develop and market injectable form of the technology in India.
As part of the deal, Oravax is eligible to get royalty payments from Premas upon marketing the injectable vaccine in India.
Kidron added: “Because Oravax is focused on oral vaccines, we saw a clear benefit to out-licensing rights to the injectable version in India, where there is an urgent need for vaccines.”
Premas intends to produce, evaluate and potentially market the injectable vaccine in India where the Covid-19 vaccine market is expected to grow to more than $2.3bn by 2027.