Oral Covid-19 Vaccine Trial Underway

(Ranys Tuunainen, Pixabay)

14 Dec. 2021. An early-stage clinical trial is underway in South Africa testing the safety of a vaccine in capsule form to prevent Covid-19 disease. Oravax Medical, a subsidiary of Oramed Pharmaceuticals Inc. in New York says the company enrolled its first participant in the trial. The study is not yet registered in ClinicalTrials.gov or other registries.

Oramed Pharma says the phase 1 or early-stage trial is enrolling 24 participants in Johannesburg who are not yet vaccinated nor infected with the SARS-CoV-2 virus. Participants in the trial are given two doses of the vaccine three weeks apart. The study team is looking primarily for signs of safety and tolerability of the vaccine, but also indicators of producing an immune response in participants against the SARS-CoV-2 virus. The company says South Africa’s Health Products Regulatory Authority approved the trial in October.

Oravax Medical, as reported by Science & Enterprise in March 2021, is a joint venture of Oramed Pharma and Premas Biotech Pvt. Ltd. in Gurugram, India. Premas Biotech develops vaccines and other protein-based pharmaceuticals from an engineered strain of Saccharomyces cerevisiae, better known as baker’s yeast, a widely studied single-cell organism. The company says it applies its own process to express antigen proteins from yeast cells, particularly those addressing cell membrane surfaces like those on viruses.

Oramed Pharma produces protein-based vaccines and therapies as oral drugs, with its lead product an ingestible insulin capsule for people with type 2 diabetes. Oramed says its technology enables protein vaccine or therapy delivery in a capsule, with a coating that protects the medication against digestive acids and enzymes. The company says its capsules also have an agent that improves absorption of protein payloads in the small intestine.

Easy to manufacture, transport, store, and administer

The two companies formed Oravax Medical to produce an oral Covid-19 vaccine to fill an eventual need for an annual vaccine that’s easy to manufacture, transport, store, and administer. These properties are particularly important in lower-resource regions of the world, where cold-chain distribution and storage needed for most injected Covid-19 vaccines may not be available.

For a Covid-19 vaccine, Premas Biotech says it developed antigens targeting the SARS-CoV-2 viral spike, like other vaccines, but also envelope and membrane proteins on the viral surface. According to Oravax Medical, the vaccine capsule candidate is formulated from virus-like particles or VLPs that address these three viral targets. The company says the multiple targets help make the vaccine less susceptible to resistance or evasion from mutations, thus potentially more effective against current and future variants.

“South Africa is a great location for the phase 1 study,” says Oramed Pharma CEO Nadav Kidron in a company statement, “as it is currently experiencing a surge in Covid cases and has struggled to obtain sufficient vaccines. It is our firm belief that an oral vaccine which eliminates syringes and eases distribution and administration, can significantly help increase vaccination rates for South Africa and similar countries.”

Kidron also notes the company expects “to rapidly complete this study and hope to advance into pivotal trials for emergency use approval in countries where our oral VLP vaccine would have the greatest impact.”

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