Premas Biotech gets approval to initiate phase 1 trials in South Africa, for Oravax’s Oral Vaccine for COVID-19

New Delhi: Premas Biotech, a developer of novel biotherapeutic and vaccine candidates, has announced that Oravax Medical Inc., a US based company that Premas Biotech is a partner in, has received clearance from the South African Health Products Regulatory Authority to commence patient enrollment in a first in human, Phase 1 clinical trial, for its oral COVID-19 vaccine.

The preparations to begin the trials are now underway.

Oravax Medical Inc. is a joint venture between Oramed Pharmaceuticals Inc. and Premas Biotech. Oravax brings together a virus-like particle (VLP) vaccine technology, developed by Premas Biotech with Oramed’s proprietary protein oral delivery (POD™) technology in the development of oral vaccines.

Premas’ virus-like particle (VLP) vaccine technology, based on its D-Crypt^TM platform, targets three SARS CoV-2 virus surface proteins, including proteins less susceptible to mutation, thus making the vaccine potentially more effective against current and future variants of the COVID19 virus. Premas’ VLP vaccine technology is highly scalable and easily transferable.

Dr Prabuddha Kundu, co-founder & MD at Premas Biotech said, “Oravax’s COVID-19 vaccine shall be the first of its kind going into human trials; its three antigenic proteins are designed to provide multipronged immune response against the virus and its variants. It can be administered orally to a much diverse population, spread across areas where logistics can be of concern. It has been shown to be very safe in animal studies, and additionally gives a mucosal IgA response apart from systemic response.”

“Oravax’s oral COVID-19 vaccine offers an exciting potential solution to the COVID pandemic, whether as a booster or for the unvaccinated. An oral COVID-19 vaccine would eliminate several barriers to rapid, widescale distribution, potentially enabling people to administer the vaccine themselves at home,” stated Oramed CEO Nadav Kidron. “Following this Phase 1 trial, our intention is to move forward with a Phase 2/3 trial for emergency use approval in relevant countries,” Kidron concluded.

The oral VLP COVID-19 vaccine is being developed for use both as a standalone vaccine as well as a booster for people who have been previously vaccinated for COVID-19. Experts including at the World Health Organization expect booster shots will be needed for both general and at risk populations. If successful, an oral vaccine would offer enormous logistical, financial, and environmental benefits for the billions of people slated to receive them, particularly in parts of the world where access to healthcare is limited.

Dr Nupur Mehrotra, co-founder & COO at Premas Biotech said, “The initial results of the Oravax’s Oral vaccine candidate from rodent and higher order animals are highly optimistic and we are delighted to get approval to initiate Phase I studies in South Africa. This can act as a catalyst to inhibit the spread of infection and variants and enable the immunisation drive at a much faster pace, even addressing the geographies which have lower penetration currently.”