Human clinical trials for Covid-19 oral vaccine beginning June 2021

Gurugram, India – A developer of novel biotherapeutic and vaccine candidates, Premas Biotech, announced the development of an oral Covid-19 vaccine shown to be effective after a single dose.

Premas, along with Oramed Pharmaceuticals Inc. and other shareholders, have partnered to form Oravax Medical Inc., an entity that would receive exclusive licences to develop oral Covid-19 vaccines, reported businesswire.com on Mar 19.

With just one dose of the Oravax Covid-19 vaccine, efficacy through antibody production was evident through a pilot animal study.

The report noted that the vaccine promoted both systemic immunity through Immunoglobulin G (IgG) and Immunoglobulin A (IgA), essential antibodies that protect against viral infections and protect the respiratory and gastrointestinal tracts from infection, respectively.

“An oral COVID-19 vaccine that harnesses and combines the true potential of the two platforms, Premas’ D-Crypt™ technology platform with Oramed’s world-leading oral protein delivery platform POD® is an excellent example of a true collaboration and can rapidly advance into late-stage clinical trials,” said Premas’ co-founder and managing director Dr. Prabuddha Kundu.

He added, “Oramed’s experience and success in conducting Phase 2 and 3 oral protein trials positions our programme very favorably in the race to find an effective oral Covid-19 vaccine that can be administered by anyone anywhere. We are looking forward to sharing clinical data soon.”

Oramed’s chief operating officer Nadav Kidron highlighted, “An oral Covid-19 vaccine would eliminate several barriers to rapid, widescale distribution, enabling people to take the vaccine themselves at home. While ease of administration is critical today to accelerate inoculation rates, an oral vaccine could become even more valuable in the likely case that a Covid-19 vaccine may be required annually or biannually like the standard flu shot.”

Oramed’s technology allows for the oral intake of several protein-based therapies that would otherwise be delivered by injection, reported The Jerusalem Post on Monday (Mar 22).

The new Oravax vaccine targets three structural proteins of Covid-19, as opposed to the single spike protein targeted by the Moderna and Pfizer-BioNTech vaccines, said Mr Kidron. Because of this, “the vaccine (Oravax) should be much more resistant to Covid-19 variants,” he added.

Mr Kidron also explained that the Oravax vaccine was yeast-based, making it cheaper to produce in terms of time and cost. Furthermore, oral medications tend to have fewer side effects, he said.

The vaccine can be shipped at refrigerator temperatures, even stored at room temperature, thus “making it logistically easier to get it anywhere around the world,” said Mr Kidron.

Lastly, he noted that an oral vaccine would not require professional administration.

According to a press release by Oramed on Mar 19, it hopes to begin Phase 1 of human clinical trials by June 2021./TISG

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