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April 23, 2021 2:03 pm

Jerusalem Drug Company Racing to Turn Insulin Technology Into Oral COVID-19 Vaccine Pill

avatar by Sharon Wrobel

A teenager receives a vaccination against the coronavirus disease (COVID-19), in Tel Aviv, Israel, January 24, 2021. REUTERS/Ronen Zvulun

Could past research into insulin help kick the world’s coronavirus inoculation drive into higher gear? An Israeli company that has long focused on converting injectable medications into oral treatments could potentially lead to a breakthrough for vaccine delivery.

Over the past 15 years, Jerusalem-based Oramed Pharmaceuticals has been working on making the first commercial oral insulin capsule for the treatment of diabetes a reality, a project that is currently in Phase 3 clinical trials. It has more recently embarked on a path to develop an oral COVID-19 vaccine pill, in what it believes to be the next-generation remedy to prevent coronavirus infection.

Oramed’s oral delivery technology, which was developed by chief scientific officer Prof. Miriam Kidron and Jerusalem’s Hadassah-University Medical Center, could become the platform of the world’s first oral COVID-19 vaccine.

Kidron founded Oramed in 2006 together with her son Nadav Kidron to commercialize the invention. Together with Nobel Prize winner Prof. Avram Hershko, they developed a previously unimaginable solution that enables proteins, such as insulin, to be delivered orally. The company says its proprietary technology potentially can be used to orally administer other protein-based therapies now available only via injection. For the purpose of developing the COVID-19 vaccine pill, Oramed in March formed a new company called Oravax Medical, which will deploy the Jerusalem-based company’s oral delivery technology and India-based Premas Biotech’s novel vaccine technology.

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Oramed CEO Nadav Kidron told The Algemeiner that the Premas vaccine candidate is likely to be more effective for protection across emerging mutations of the coronavirus, as it adopted the virus like particle (VLP) approach, which targets three structural proteins. In comparison, the vaccines developed by Pfizer and Moderna target only one — the so-called spike (S) protein, which prompts the immune response to the coronavirus, but has shown to mutate.

For now, Oravax’s single-dose oral vaccine candidate, which can be stored at room temperature and doesn’t need to be refrigerated, has shown to produce the desired antibodies in a pilot study in pigs conducted in Israel, which Kidron called a “nice” immune response. According to the pre-clinical study, the vaccine triggered the development of Immunoglobulin G (IgG) antibodies and Immunoglobulin A (IgA). Next, Oravax will need to show that these results can be replicated in clinical human trials, which are expected to kick off around June in multiple places, including Israel and the US.

Meanwhile, Vaxart — a San Francisco-based biotech company which is also developing an oral COVID-19 vaccine tablet — reported in February that according to preliminary data from its Phase 1 human trial study of VXA-CoV2-1, neutralizing antibodies were not detected.

“Of course there are no guarantees until we start human trials but we believe there is more than 90% chance that it will work on humans,” Kidron said. “We have worked on an oral delivery platform for many, many years now and have become experts with the success development of the delivery of oral insulin.”

Kidron added that the benefits of a COVID-19 vaccine pill are more than just ease of taking the drug, since there is no need to see health-care professional and it allows for self-administration at home. It is also highly scalable and is expected to cost half as much other technologies, as it is a yeast-based vaccine pill. Additionally, studies have shown that oral vaccine delivery generally can have fewer adverse side effects than injection-based administration.

Vaccine distribution also represents a limiting factor, particularly in developing nations, such as parts of Africa, that have limited healthcare  infrastructure resources and a fear of injections, according to Kidron.

Israel’s rapid vaccination campaign — which has now given at least one dose to nearly two-thirds of its citizens — remains an outlier. African countries have administered less than 2% of the world’s total doses given, according to the University of Oxford’s Our World in Data project, and many countries have still only vaccinated single-digit shares of their population.

As the world struggles with a resurgence in coronavirus cases and the quest for rapid immunization, “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,” Kidron added. “It would also eliminate occupational needle stick injuries and the bio-hazardous waste problem.”

“We are overwhelmed by the amount of interest we are receiving in our pill. Every day I am getting a call from potential buyers. We have already been contacted by a number of Western and non-Western countries,” said Kidron. “Currently the facility in India can produce 100 million vaccine doses a year. We are also in discussions with another country to set up another facility so that we can expand manufacturing capacity.”

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