By ABIGAIL KLEIN LEICHMAN
(Israel21C via JNS) – Several COVID-19 vaccines under development in Israel hold out promise for their ability to protect against variants of the virus that are challenging existing vaccines.
Back in May 2020, research groups across the world were racing to formulate vaccines against the SARS-CoV-2 coronavirus.
Realizing it was not going to win that race, Israel purchased millions of Pfizer-BioNTech and Moderna mRNA vaccines from the United States and led the world in getting eligible citizens vaccinated.
However, domestic inoculations still to come may become significant as primary vaccinations or as boosters against highly contagious variants of the virus.
U.S.-based NRx Pharmaceuticals will receive a license for exclusive worldwide development, manufacturing and marketing rights to the novel BriLife coronavirus vaccine developed by the Defense Ministry’s Israel Institute for Biological Research (IIBR).
BriLife is based on a previous, FDA-approved vaccine platform that was further optimized by IIBR and targeted at COVID-19. Because it is a live-virus vaccine, NRx anticipates rapid and affordable industrial scaleup and manufacturing.
“As the first-generation COVID vaccines are increasingly challenged by rapid mutation of the coronavirus, we aim to develop a vaccine that can rapidly scale at low cost to serve the needs of both the developed and the developing world,” says Chaim Hurvitz, director of NRx, chairman of Israeli private equity group CH Health, former director of Teva Pharmaceuticals and former president of the Teva International Group.
Hurvitz is co-leading this initiative with NRx Pharmaceuticals chairman and CEO Dr. Jonathan Javitt, a public-health expert who had leadership roles in seven successful healthcare IT and biopharma startups, and led drug-development programs for Merck, Allergan, Pharmacia, Novartis and Pfizer.
Javitt tells ISRAEL21c that BriLife presents the entire spike protein of the coronavirus to the body’s immune system, while mRNA vaccines present a small slice of the spike protein to the immune system.
“We expect BriLife will create a broader immunological response and will enhance protection against COVID-19 and its variants,” says Javitt.
BriLife is continuing Phase II clinical trials in Israel and the nation of Georgia. Phase III trials are to take place in Georgia, Ukraine and other European countries.
MigVax, a vaccine-development startup spun out of the Israeli Science and Technology Ministry’s Migal Galilee Research Institute, is developing an oral COVID-19 vaccine, MigVax-101.
This “sub-unit” vaccine contains pieces of coronavirus protein (not live or dead virus) delivered by mouth to stimulate antibodies and immune cells to fight coronavirus in mucosa, blood and cells.
On June 10, MigVax released results from preclinical tests on lab rats that demonstrated the potential effectiveness of MigVax-101 as an antibody booster for previously vaccinated people.
Now the company is raising funds to launch Phase I and Phase II human clinical trials. If such trials prove successful, the vaccine could be commercialized within a year after the trials begin.
An oral vaccine offers significant advantages over injected vaccines because it could be taken at home—no appointments, waiting for turns or sore arms. Although it would have to be refrigerated, it would not need “deep freeze” conditions that make the mRNA vaccines expensive and difficult to ship and store.
MigVax says that its vaccine candidate is uniquely positioned to tackle new variants because the subunit can be adapted quickly to novel variants.
And its protein components are stable, meaning the vaccine may remain effective for longer periods before requiring a booster.
Furthermore, MigVax-101 could be more acceptable to a wider population, including people wary of receiving injections of genetic or viral material, as well as infants, children, pregnant women and others.
“The results of this trial increase our confidence that our MigVax-101 subunit oral vaccine will make a positive contribution to a world coming to grips with the new post-pandemic reality,” comments Prof. Itamar Shalit, MigVax’s infectious disease expert. “Oral boosters such as our MigVax-101 will be key enablers that will help health organizations the world over transition from ‘panic mode’ to routine, due to their ability to reduce the cost and expand the reach of ongoing vaccination programs.”
Another oral COVID-19 vaccine is under development at Oravax Medical, a subsidiary of Jerusalem-based Oramed Pharmaceuticals formed last March as a joint venture with India-based Premas Biotech.
Oravax capitalizes on Oramed’s proprietary protein oral delivery (POD) technology and Premas’s exclusive virus-like particle vaccine technology, which will target three SARS CoV-2 virus surface proteins—including proteins less susceptible to mutation.
That could make Oravax potentially effective against current and future mutations, both as a standalone vaccine and as a booster for previously vaccinated people.
“Our vaccine is a particularly strong candidate against the evolving COVID-19 virus due to its unique targeting of three proteins rather than one,” says Nadav Kidron, CEO of Oramed.
Oravax completed a successful pilot study on animals. Now the vaccine candidate is being tested in animals against variants, including the Delta variant.
Proof-of-concept clinical trials are soon to start in Israel at Tel Aviv Sourasky Medical Center to measure the level of antibodies and other immunity indicators.
Kidron has said that Oramed initially wants to target its vaccine to countries that haven’t been able to afford mRNA vaccines for their populations. An oral vaccine, as stated above, is less costly to ship, store and administer without the need of healthcare professionals.
Several other potential Israeli vaccines are in the early stages of development, some of them in labs at universities including the Technion-Israel Institute of Technology, Tel Aviv University and Bar-Ilan University.
An oral sub-unit coronavirus vaccine being developed in Rehovot at TransAlgae would use an edible delivery vehicle based on engineered algae.
Bioencapsulated inside the algae, a specific coronavirus protein molecule travels intact through the digestive system to stimulate its target, the immune system.
Eyal Ronen, VP for business development, told ISRAEL21c this vaccine candidate is undergoing preclinical trials. TransAlgae is seeking collaborations and strategic partnerships with American companies to advance development.
The company’s main field of expertise is animal and fish vaccines, as well as crop insecticides.
“We are not a pharma company and were not interested in going into human health at this moment. But our shareholders were asking us, why not use this for human beings? We took the challenge,” says Ronen.