A Covid vaccine in capsule form soon, to be co-developed by India’s Premas Biotech

Indian private sector firm Premas Biotech is working on a Covid-19 vaccine candidate that can be taken in the form of an oral capsule, its managing director Dr Prabuddha Kundu told The Gurugram-based biotechnology firm, which specialises in developing recombinant proteins for vaccine development, has partnered with the Jerusalem-headquartered Oramed Pharmaceuticals. Oramed specialises in transforming injectable treatments into oral drug form, and is best known for an insulin capsule for type 1 diabetes, which is in the advanced stages of trial.
Premas and Oramed’s joint venture, as well as the capsule under development, is called OraVax.
“A single dose of the vaccine tablet or capsule has proven to be efficacious in animal studies. OraVax product is different as it would not require any special delivery mechanism and cold storage,” Kundu said. “If proven efficacious, this vaccine will give a lot of benefits to the world as it would not require syringes or administration in hospital settings.”
Kundu claimed that in the pilot animal studies, OraVax promoted both systemic immunity by producing neutralising antibodies (IgG) as well as immune response (IgA), which protect the respiratory and gastrointestinal tracts against infection. But the findings have not yet been peer-reviewed or published in a scientific journal.
VLP technology
The division of responsibilities in the Indian-Israeli joint venture is such that Premas Biotech will work on developing the vaccine itself, while Oramed will work on the oral delivery part.
In May last year, Premas had announced the completion of its vaccine prototype, which was considered a significant breakthrough in vaccine development efforts.
“The vaccine prototype is among the first in the world for virus-like particles (VLP) of SARS-CoV-2 virus,” the company had then said in a statement. “We believe that this combination of three proteins distinguishes us from other companies seeking to develop Covid-19 vaccines and makes the VLP promising as we work to proceed into pre-clinical trials.”
Kundu said of his company’s vaccine: “It provides triple protection against Covid-19 by destroying three parts of the virus: Spike, membrane, and envelope E targets.”
VLPs, according to an article in Pubmed journal, are multiprotein structures that mimic the organisation and conformation of authentic native viruses but lack the viral genome, “potentially yielding safer and cheaper vaccine candidates”.
Other vaccine candidates that use VLP platforms are GlaxoSmithKline’s Covid-19 vaccine and Merck’s Hepatitis B and HPV vaccines.
Company to approach DCGI after phase-I trials
The joint venture, OraVex Medical Inc., is applying for phase-I clinical trials in several countries. “In fact, multiple countries are reaching out and showing interest in the vaccine candidate,” Kundu said, refusing to divulge the names the company is planning for.
“As phase-I trials get over, the regulatory authorities of those countries will take a closer look and the future of the product will become certain,” he added.
The company will initiate discussions with the Drug Controller General of India — the apex health regulatory authority — after collecting the data from phase-I trials.
“Once we have phase-I data in hand, it will be more appropriate to get in contact with authorities in India and other countries,” Kundu said, adding that now India has enough vaccine candidates and there is no emergency or rush.
Source – ThePrint