Oravax Medical is gearing up to commence clinical trials at Tel Aviv Sourasky Medical Center.
Israel is about to become the first country in the world to test the oral COVID-19 vaccine developed by Oramed Pharmaceuticals, the company’s CEO Nadav Kidron told The Jerusalem Post.
Oramed’s subsidiary, Oravax Medical, is gearing up to commence clinical trials of its vaccine at Sourasky Medical Center in Tel Aviv after receiving approval for its study protocol from the hospital’s Institutional Review Board. It is now waiting for approval from the Health Ministry, which is expected within a few weeks.
Oravax already completed GMP manufacturing in Europe of several thousand capsules that would be available for the Israeli trial and eventually in other countries.
Oramed is a clinical-stage pharmaceutical company based on technology developed by Jerusalem’s Hadassah-University Medical Center. In March, it announced a joint venture with India-based Premas Biotech to develop a novel oral vaccine. Together they formed Oravax. The vaccine is based on Oramed’s “POD” oral delivery technology and Premas’s vaccine technology.
Oramed’s technology can be used to orally administer a number of protein-based therapies, which would otherwise be delivered by injection. Oramed is in the midst of a Phase III clinical trial through the US Food and Drug Administration of an oral insulin capsule for Type 1 and Type 2 diabetes.
Premas has been working on developing a vaccine against the novel coronavirus since March.
The new Oravax vaccine candidate targets three structural proteins of the novel coronavirus, as opposed to the single spike protein targeted by the current Moderna and Pfizer vaccines, Kidron said.
As such, “this vaccine should be much more resistant to COVID-19 variants,” he said. “Even if the virus gets through one line, there is a second line, and if through the second line, there is a third.”
The vaccine is being tested in preclinical studies against COVID-19 variants, including the Delta one.
The company completed a pilot animal study and found that the vaccine promoted the development of Immunoglobulin G (IgG) antibodies and Immunoglobulin A (IgA). IgA is necessary for longer-term immunity.
The protocol for the inaugural Phase I/II trial that the company hopes to move forward with at Sourasky would involve 24 volunteers who have not yet been inoculated with another vaccine. Half of the group would take one capsule, and the other half would take two, Kidron said, adding that there is no placebo group because the goal is to measure the level of antibodies and other immunity indicators.
“The idea here is that we want to show proof of concept: that it works for people,” he said. “I pray and hope that we will. Imagine that we could give someone an oral vaccine and they are vaccinated. This would be a revolution for the entire world.”
With proof of the concept, “the whole world opens up,” Kidron said.
“An oral COVID-19 vaccine would eliminate several barriers to rapid, wide-scale distribution, potentially enabling people to take the vaccine themselves at home,” he told the Post. “While ease of administration is critical today to accelerate inoculation rates, an oral vaccine could become even more valuable in the case that a COVID-19 vaccine may be recommended annually like the standard flu shot.”
The advantages of an oral vaccine go beyond safety and efficacy because oral medications tend to have fewer side effects, Kidron said.
The vaccine can be shipped at refrigerator temperatures and even stored at room temperature, “making it logistically easier to get it anywhere around the world,” he added.
Finally, an oral vaccine would not require professional administration.
The Phase I/II trial is expected to take around six weeks from the time of recruitment.
If the trial is successful, Kidron said he plans to put the vaccine on an accelerated road to receive emergency-use approval in the countries that need it most, such as those in South America that have not been able to acquire enough vaccines to inoculate their populations.
The company would hold its Phase III trial with a limited number of volunteers and look for first approval in one of these “emerging markets,” Kidron said, and only later seek US Food and Drug Administration authorization.
“Israel and the US and some of the other richer countries were the first to get Pfizer and Moderna,” he said. “But it looks to me like the people behind in the race will take over by being the first ones to get the oral vaccine.”
