Israel to become first in the world to test Oravax’s oral COVID-19 vaccine

Israel Set To Become First Country In The World To Test Oral COVID-19 Vaccine Developed By Oramed Pharmaceuticals, Company CEO Nadav Kidron Says Jerusalem post.

Oramed’s subsidiary, Oravax Medical, is preparing to begin clinical trials of its vaccine at Sourasky Medical Center in Tel Aviv after receiving approval of its study protocol by the hospital’s institutional review board. He is now awaiting approval from the Ministry of Health, which is expected within a few weeks.

Oravax has already completed GMP manufacturing in Europe of several thousand capsules that would be available for testing in Israel and possibly in other countries.

Photograph of Oramed Pharmaceuticals CEO Nadav Kidron (Courtesy)Photograph of Oramed Pharmaceuticals CEO Nadav Kidron (Courtesy)

Oramed is a clinical-stage pharmaceutical company based on technology developed by the Hadassah-University Medical Center in Jerusalem. In March, she announced a joint venture with Indian company Premas Biotech to develop a new oral vaccine. Together they formed Oravax. The vaccine is based on Oramed’s’ POD ‘oral delivery technology and Premas’ vaccine technology.

Oramed’s technology can be used to deliver a number of protein therapies orally, which would otherwise be given by injection. Oramed is in the midst of a Phase III clinical trial by the United States Food and Drug Administration of an oral insulin capsule for type 1 and type 2 diabetes.

Premas has been working on the development of a vaccine against the new 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 is expected to be much more resistant to the COVID-19 variants,” he said. “Even if the virus crosses a line, there is a second line, and if across the second line, there is a third. “

The vaccine is being tested in preclinical studies against variants of COVID-19, including that of Delta.

The company performed a pilot study in animals and found that the vaccine promoted the development of immunoglobulin G (IgG) and immunoglobulin A (IgA) antibodies. IgA are necessary for long 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 yet to be inoculated with another vaccine. Half the group would take one capsule and the other half would take two, Kidron said, adding that there was no placebo group because the goal is to measure the level of antibodies and other indicators of ‘immunity.

“The idea here is that we want to show a proof of concept: that it works for people,” he said. “I pray and hope we will. Imagine that we could give someone an oral vaccine and they were vaccinated. It would be a revolution for the whole world.

With proof of concept, “the whole world is opening up,” Kidron said.

“An oral COVID-19 vaccine would remove several barriers to rapid and large-scale distribution, potentially allowing people to take the vaccine themselves at home,” he told the Post. “While ease of administration is essential today to speed up inoculation rates, an oral vaccine could become even more valuable in the event that a COVID-19 vaccine could be recommended each year as the standard influenza vaccine. “

The benefits of an oral vaccine go beyond safety and effectiveness, as oral medications tend to have fewer side effects, Kidron said.

The vaccine can be shipped at refrigerator temperature and even stored at room temperature, “making it logistically easy to get anywhere in the world,” he added.

Finally, an oral vaccine would not require professional administration.

The Phase I / II trial is expected to last approximately six weeks from enrollment.

If the trial is successful, Kidron said he plans to put the vaccine on a fast track to receive emergency use approval in countries that need it most, such as those in South America who do not ‘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 seek first approval in one of those “emerging markets,” Kidron said, and would only seek approval from the Food and Drug Administration for later. United States.

“Israel and the United States and some of the other wealthier countries were the first to get Pfizer and Moderna,” he said. “But it seems to me that the people behind in the race will take over by being the first to receive the oral vaccine.”

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