NEW YORK, July 21, 2021 – Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced several updates for its majority-owned company Oravax Medical Inc.

Oravax capitalizes on Oramed’s proprietary protein oral delivery (POD™) technology in the development of oral vaccines that are now only available via injection. Oravax is the exclusive owner of a virus-like particle (VLP) vaccine technology that targets three SARS CoV-2 virus surface proteins, including proteins less susceptible to mutation, thus making the vaccine potentially effective against current and future variants of the COVID-19 virus. The VLP vaccine is being tested in preclinical studies against COVID-19 variants including the Delta variant. Oravax’s VLP vaccine technology is highly scalable with a low cost of goods and easily transferable. 

Clinical Trial of Oral COVID-19 Vaccine Moving Forward

Oravax is gearing up to commence clinical trials for its oral COVID-19 vaccine, first in Israel, then in additional clinical sites internationally. The study protocol has been approved by the Institutional Review Board (IRB) at Ichilov Hospital in Tel Aviv, Israel and is now pending approval from the Israeli Ministry of Health. GMP manufacturing for the oral vaccine is under way.  

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.  

“Our vaccine is a particularly strong candidate against the evolving COVID-19 virus due to its unique targeting of three proteins rather than one. With the Delta and other variants proving a challenge to health administrators globally, Oravax’s VLP technology could prove even more important in the effort to combat COVID,” said Nadav Kidron, CEO of Oramed.

Oravax Holdings

Oramed is currently evaluating several options with respect to its interest in Oravax, including distributing a portion of its holdings to its shareholders. Subject to applicable law, Oramed will keep shareholders advised of developments.

Premas to Develop and Commercialize VLP Injectable Technology in India  

Oravax, the exclusive owner of the VLP technology, has out-licensed certain rights in the territory of India to Premas Biotech, the original developer of the novel vaccine.  As Oravax maintains its focus on oral vaccines, it has licensed to Premas the right to develop an injectable version of its VLP technology with an aim to address the urgent need for a vaccine which is effective against the Delta variant. Oravax is entitled to royalties upon commercialization of this vaccine in India.  

“Oravax’s VLP platform technology can be delivered either via injection or orally. Because Oravax is focused on oral vaccines, we saw a clear benefit to out-licensing rights to the injectable version in India, where there is an urgent need for vaccines,” Kidron added. 

Premas plans to manufacture, test, and potentially commercialize the injectable version of the VLP vaccine in India where the COVID-19 vaccine market is anticipated to grow to over $2.3 billion by 2027. India is currently in a race to speed up the pace of COVID-19 vaccinations for its population of 1.4 billion as the country’s death toll from the pandemic has topped 400,000 with 31 million cases. 

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 

About Oramed Pharmaceuticals

Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule. 

For more information, please visit www.oramed.com.

Forward-looking statements:  This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential of the Oravax vaccine or booster to be effective against COVID-19 and other potential benefits of an oral COVID-19 vaccine, future clinical trials and approvals, potential options with respect to Oramed’s interest in Oravax, the potential for royalties and other benefits from the license to Premas, the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes or revolutionizing the treatment of diabetes with our products. In addition, historic results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the Securities and Exchange Commission.

Company Contact

Estee Yaari 

+1-844-9-ORAMED
estee@oramed.com

The post Oramed Provides Update on Oravax: Oral Vaccine Maker Gets IRB Approval for Clinical Trial appeared first on Oravax.

Israeli pharmaceutical Oramed is attempting to accomplish just that, and is poised to start its first clinical trial in early August, CEO Nadav Kidron told AFP in an interview.

With just 15 percent of the world’s population fully vaccinated, the global fight to end the pandemic is far from over.

Oral vaccines are particularly attractive for the developing world, because they reduce the logistical burden of immunization campaigns, said Kidron.

But they could also increase uptake in wealthy countries where needle aversion is an often missed factor in hesitancy.

A recent survey found nearly 19 million Americans who decline vaccines would take them if they had a pill option.

“In order for the vaccine to really work well, we need as many people to take it as possible,” said Kidron.

Other benefits include reduced syringe and plastic waste, and potentially fewer side effects.

Challenges for oral delivery

Despite many theoretical advantages, there have been few successful oral vaccines because the active ingredients tend not to survive the journey through the gastro-intestinal tract.

Exceptions include vaccines for diseases that are themselves transmitted through the mouth and digestive system – for example there is an effective oral polio vaccine.

Oramed, which was founded in 2006, believes it has overcome the technical hurdles by designing a capsule that survives the highly acidic environment of the gut.

It invented its technology for a previous product, an experimental oral form of insulin, the lifesaving drug required by diabetics that has until now been only administered by injection.

Developed with Nobel Prize winning biochemist Avram Hershko who is on Oramed’s scientific advisory board, the company’s capsule has a highly protective coating that makes it slow to degrade.

It also releases molecules called protease inhibitors that stop enzymes in the small intestine from breaking down the insulin, and an absorption enhancer to help the insulin cross into the bloodstream.

This drug has been dosed in hundreds of patients in late stage clinical trials in the US, with results expected in September 2022.

Oramed has now launched a new majority-owned company called Oravax, which takes the capsule technology from the oral insulin product and uses it for an oral COVID-19 vaccine.

Virus-like particle

To evoke an immune response, the company’s scientists have designed synthetic coronavirus-like particles.

These mimic three key structures of the pathogen: the spike protein, the envelope protein and the membrane protein.

Most currently authorized vaccines, like Pfizer or AstraZeneca, are based on the spike protein alone, making them less protective over time as the spike protein of the coronavirus mutates.

By targeting multiple parts of the virus, including structures that mutate less, the Oravax vaccine could be more variant-proof, Kidron said.

The company has applied to begin trials in multiple countries and expects to begin its first in Israel within weeks, pending approval from the health ministry.

Kidron said he foresaw a role for the vaccine initially in developing countries which haven’t yet bought up enough supply of current vaccines – before eventually developed markets.

A vaccine pill could become especially attractive if ongoing boosters are required.

If it’s successful, it would also represent a proof of concept for future orally administered vaccines, he added.

“Imagine… the flu vaccine comes to you in the mail, you take it, you’re done.”

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The post Gulf News: An oral COVID vaccine is nearly ready, will it help end the pandemic? appeared first on Oravax.

Amid rising cases of Covid-19 driven by the infectious Delta variant, Israel is gearing up to host the first clinical trials of an oral Covid-19 vaccine, which could help boost access to vaccines around the world and serve as a more convenient booster in the future.  

KEY FACTS

Oravax Medical, a company focused on developing ways to deliver drugs by mouth, is preparing to begin clinical trials of its oral Covid-19 vaccine in Israel after getting the green light from the review board at Ichilov Hospital, Tel Aviv’s main hospital. 

The trials—pending recruitment and final approval from the country’s health ministry in coming weeks—will initially serve as a “proof of concept” for the capsule vaccine, said Nadav Kidron, CEO of Oravax’s parent company Oramed Pharmaceuticals, in an interview with The Jerusalem Post.  

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The first trial will involve 24 unvaccinated volunteers, each taking one or two pills, and will investigate the vaccine’s safety and indicators of immunity, moving on to larger Phase 3 trials to demonstrate efficacy if successful. 

The vaccine should be “much more resistant to Covid-19 variants,” Kidron said, as it trains the immune system against three viral proteins instead of the single protein targeted by Pfizer and Moderna shots.

Oravax is also developing the capsule as a booster for people who have been vaccinated against Covid-19 before, though its plans to test this are unclear . 

WHAT TO WATCH FOR

Should the trials prove a success, it could be a long while before the oral vaccine is approved in the U.S. Kidron said the company’s priority would be getting the vaccine to those who need it most first, only seeking FDA authorization at a later date. Oravax would seek expedited emergency approval in countries that have not been able to acquire enough vaccines, Kidron said, though it is unclear how this goal will work alongside developing the vaccine as a booster. ​​Given the vast disparities in vaccine access around the world, World Health Organization head Dr. Tedros Adhanom Ghebreyesus slammed the “greed” of pharmaceutical companies lobbying for booster shots while many people have yet to be vaccinated at all. 

KEY BACKGROUND

An oral vaccine would help eliminate many of the barriers hindering widespread immunization around the world. They are easier to transport and store, are unlikely to require the ultracold temperatures Pfizer and Moderna’s shots need and, importantly, are not administered with needles. No-needle vaccination is a boon to those scared of needles, it cuts down on equipment and the risk of blood borne diseases and can be administered by people without medical training. Despite their benefits, few oral vaccines are in widespread use owing to the hostile nature of the digestive tract. Those that are—notably for polio, cholera, rotavirus and typhoid—often feature more robust pathogens capable of withstanding the conditions.    

TANGENT

Oravax is not the only company developing an oral Covid-19 vaccine. Efforts are also underway to develop nasal spray forms of Covid-19 vaccines. 

FURTHER READING

Israel to become first in world to test oral COVID-19 vaccine (Jerusalem Post)

published on Forbes https://www.forbes.com/sites/roberthart/2021/07/22/oral-covid-vaccine-set-to-begin-trials-in-israel/?sh=3b02717c1ba5

The post Jerusalem Post: Oral Covid Vaccine Set To Begin Trials In Israel appeared first on Oravax.

• Good candidate for protection against COVID variants due to triple antigen targeting
• Implications for potential ease of widescale distribution and administration anytime, anywhere for oral COVID-19 vaccine
• Efficacy following a single oral dose administration in preclinical study
• Clinical trial expected to commence Q2 2021
• Watch video
• Successful expansion of Oramed’s POD™ oral delivery technology into the lucrative vaccine development market

New York – March 19, 2021

Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) ( www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has entered into definitive agreements to form a joint venture focused on the development of novel oral COVID-19 vaccines. The new company, Oravax Medical Inc., is based on Oramed’s proprietary POD™ oral delivery technology and Premas Biotech Pvt. Ltd.’s novel vaccine technology.

Oravax’s COVID-19 vaccine candidate benefits from being a virus like particle (VLP) triple antigen vaccine that targets three structural proteins, which should make it a better candidate for protection across emerging mutations of the coronavirus. The oral delivery of the vaccine should allow for widescale inoculation and easier distribution of the vaccine without requiring an injection.

In a pilot animal study, the oral COVID-19 vaccine promoted both systemic immunity through Immunoglobulin G (IgG), the most common antibody in blood and bodily fluids that protects against viral infections, and Immunoglobulin A (IgA).

Oravax anticipates commencing a clinical study during the second quarter of 2021.

“An oral COVID-19 vaccine would eliminate several barriers to rapid, widescale distribution, potentially 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 case that a COVID-19 vaccine may be recommended annually like the standard flu shot,” said Nadav Kidron, CEO of Oramed.

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

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary lead candidate, ORMD-0801 , which has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. The Company has completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901.

For more information, please visit www.oramed.com.

Company Contact

Estee Yaari
+1-844-9-ORAMED Ext: 2
estee@oramed.com

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