Premas Biotech Announces Approval to Initiate Phase 1 Trials in South Africa for Oravaxs Oral Vaccine for COVID19

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Premas Biotech Announces Approval to Initiate Phase 1 Trials in South Africa, for Oravax's Oral Vaccine for COVID-19

  • Friday, October 29, 2021 6:31PM IST (1:01PM GMT)
 
Gurugram, Haryana, India:  
  • Premas Biotech earlier developed a virus-like particle (VLP) vaccine candidate for Covid-19 through its proprietary D-CryptTM technology and is a JV partner in Oravax Medical Inc. together with Oramed Pharmaceuticals.
  • Premas Biotech has licensing deal for virus-like particle (VLP) injectable vaccine technology for COVID-19, with Oravax for commercialization in India

Premas Biotech, a developer of novel biotherapeutic and vaccine candidates, today 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; and preparations to begin the trials are now underway.

Oravax Medical Inc. is a joint venture between Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) 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-CryptTM 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.”
 
For more information on Oravax’s vaccine candidate, please visit https://www.youtube.com/watch?v=98ZZctr4vZI


About Premas Biotech

Premas Biotech develops novel technologies and partners with global biopharmaceutical companies to build and develop novel biotherapeutic & vaccine candidates. Premas' key focus areas are infectious diseases, cancer, metabolic disorders and inflammation. Besides D-CryptTM the difficult to express proteins expression platform, Premas’ leading technologies include Axtex-4D™: an ex-vivo tissueoid generation platform and C-Qwence™: a fully human naive India based scFv antibody library. Further information is available on the Company’s website: www.premasbiotech.com
 
About Oravax Medical Inc.

Oravax was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech and certain other shareholders with a mission to bring an oral COVID-19 vaccine to the market. Oravax combines cutting-edge vaccine technology acquired from Premas Biotech and the proprietary POD™ oral delivery technology of Oramed Pharmaceuticals. For more information, please visit www.ora-vax.com
Click here for Media Contact Details

Ambar Mehrotra, Premas Biotech, [email protected], +91-8968482266, +91-124-454 6600

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