An Israeli-American pharmaceutical company is preparing to launch a Phase I clinical trial for what could become the world’s first oral COVID-19 vaccine.
Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company based on technology developed by Hadassah-University Medical Center, announced over the weekend a joint venture with India-based Premas Biotech to develop a novel oral vaccine. Together they formed the company Oravax Medical Inc. 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 companies connected earlier this year and quickly realized they could revolutionize the marketplace, according to Oramed CEO Nadav Kidron.
“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 Jerusalem 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 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 new Oravax vaccine candidate targets three structural proteins of the novel coronavirus, as opposed to the single spike protein targeted via the Moderna and Pfizer vaccines, Kidron said. As such, “this vaccine should be much more resistant to COVID-19 variants,” he said
In addition, it is a yeast-based vaccine, making the time and cost of production much cheaper than its already approved competitors.
The advantages of an oral vaccine go beyond safety and efficacy, Kidron said. Oral medications tend to have fewer side effects.
In addition, 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,” Kidron said.
Finally, an oral vaccine would not require professional administration.
Oravax anticipates commencing a clinical study during the second quarter of 2021. It is applying for trials in multiple countries, including the United States, Israel, Europe and Mexico, Kidron said. It hopes to also target Africa, where such an oral vaccine could prove essential.
Kidron said he expects Phase I human trial data to be available within three months.
In February 2020, shortly after the start of the COVID-19 pandemic, another Israeli team began development on what they hoped would be an oral coronavirus vaccine. Scientists from the Galilee Research Institute’s biotechnology group said they were primed to develop their vaccine within a few months.
They had been developing a vaccine against avian coronavirus, which had been proven effective in preclinical trials, and they believed it would translate to a human vaccine. Despite a commitment by the Science and Technology Ministry to fast-track approval of the vaccine and a $12 million investment by OurCrowd, the vaccine has yet to come to market.
The Post contacted the institute’s researchers and representatives several times in recent months for a status update, but none was provided.