NEW YORK, Oct. 7, 2022 /PRNewswire/ — Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced that its subsidiary, Oravax Medical Inc., reported positive preliminary data from its Phase 1 trial of an oral Covid-19 vaccine candidate.

Preliminary Phase 1 trial results from the first cohort include:

• Significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune response to VLP vaccine antigens observed in majority of the patients dosed
• No safety issues observed, including mild symptoms

Oravax Medical is a clinical-stage vaccine company developing oral vaccines that combine Oramed Pharmaceuticals’ POD™ technology with Premas Biotech’s D-Crypt™ Platform. Oravax’s oral Covid-19 vaccine candidate is designed using D-Crypt™ technology as a triple antigen VLP vaccine that targets three major surface proteins of the SARS-CoV-2 virus – Spike, Membrane and Envelope. This should allow the oral vaccine candidate to trigger a protective response not only against the prevalent strains of the SARS-CoV-2 virus, but also the emerging mutations.

“We’re very encouraged by this initial data, which indicates that our platform can be safely and successfully used to orally deliver protein-based vaccines,” said Nadav Kidron, Chairman of Oravax and CEO of Oramed Pharmaceuticals.

“These results, together with the recent evolution of the Covid strains, further raise our confidence in the success of an oral Covid-19 vaccine and the broad potential of our platform along with Oramed’s POD™ platform to explore oral vaccines for other infectious diseases,” said Dr. Prabuddha Kundu, Co-founder and Managing Director, Premas Biotech.

About the Trial

An open label, Phase 1, first-in-human, proof-of-concept, dose escalation, dose-finding trial in up to 24 healthy volunteers. The trial will evaluate the safety, tolerability, and immunogenicity of two concentrations of Anti-SARS-CoV-2 vaccine administered orally as a two-dose schedule, administered 21 days apart.

The first cohort of 12 eligible subjects received one capsule containing the low dose on day 1 and a second oral dose on day 21. The ongoing trial is to include an additional 12 subjects (subjects 13-24) who are to receive a high dose on day 1 and a second dose on day 21.

Subjects will be monitored for safety, tolerability and antibody titers for a period of 24 weeks after the first dose administration. An end of trial visit will take place 24 weeks after the first dose.

About Oravax

Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech, MyMD Pharmaceuticals, 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: ORMP) (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 (ORMD-0901). 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 development of an oral Covid-19 vaccine, the pace of studies and trials for such oral vaccine and the potential effectiveness, safety, immunogenicity and other advantages of the vaccine against current and future coronavirus strains or for the broader vaccines market and the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes. 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:
Zach Herschfus
+1-844-9-ORAMED
zach@oramed.com

The post Oramed Subsidiary Oravax Reports Positive Preliminary Phase 1 Data for its Oral Covid-19 Vaccine appeared first on Oravax.

Oramed oral COVID vaccine shows promise in phase 1 trial | Seeking Alpha

The post Seeking Alpha: Oramed oral COVID vaccine shows promise in phase 1 trial appeared first on Oravax.

Prospective patient population of approximately 660 million throughout the Association of Southeast Asian Nations

NEW YORK, Dec. 29, 2021 /PRNewswire/ — Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced that its subsidiary, Oravax Medical, has signed a Cooperation and Purchase Agreement with Vietnam-based Tan Thanh Holdings Investment Joint Stock Company to pre-purchase Oravax’s oral COVID-19 vaccine, currently in development. The agreement grants Tan Thanh Holdings the right to sell Oravax’s oral vaccine in development throughout the Association of Southeast Asian Nations (ASEAN) which includes Vietnam, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore and Thailand. The Agreement is for an initial pre-order of 10 million doses of oral COVID-19 vaccines from Oravax and is comprised of milestone payments. The parties have agreed to negotiate follow-on orders potentially worth hundreds of millions of dollars.

Tan Thanh Holdings, which operates one of the fastest growing pharmaceutical businesses in the ASEAN region, has received approval from Vietnam’s Ministry of Health to conduct advanced stage clinical trials of Oravax’s oral COVID-19 vaccine in development and will contribute to the funding and implementation of clinical development and regulatory approval. The ASEAN region spends close to 4% of GDP on healthcare and its pharmaceutical industry is valued at $25 billion and is expected to experience continued growth.

“This pre-purchase of our oral COVID-19 vaccine in development, represents a major milestone for Oravax Medical and another step forward in the implementation of our long-term strategy. With the dramatic increase in positive cases of the Omicron variant, the global need for an oral vaccine that protects against current and future variants is crucial. An oral COVID-19 vaccine would significantly improve vaccination logistics and reduce costs. We view Tan Thanh Holdings as an ideal partner to bring our vaccine to Vietnam and the ASEAN region,” stated Oramed Chief Executive Officer and Oravax Chairman Nadav Kidron.

Oravax’s oral VLP vaccine in development 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 COVID-19 virus. Oravax’s VLP vaccine technology is highly scalable for manufacturing and is easily transferable for logistical wide scale distribution as there is no need for subfreezing storage.

About Oravax

Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech, MyMD Pharmaceuticals, 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 (ORMD-0901).

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 development and timing of an oral COVID-19 vaccine, the pace of studies and trials for such oral vaccine and the potential effectiveness, safety, scalability and other advantages of the vaccine, the value of potential future orders of such oral vaccine, the contribution of Tan Thanh Holdings to the clinical development and regulatory approval of such oral vaccine, the expected growth of the pharmaceutical industry in the ASEAN region or the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes. 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
Zach Herschfus
+1-844-9-ORAMED
zach@oramed.com

The post Oramed Subsidiary Oravax Medical Signs Cooperation and Purchase Agreement for an Initial Pre-Purchase of 10 Million Doses of Oral COVID-19 Vaccines with Tan Thanh Holdings to Commercialize in Southeast Asia appeared first on Oravax.

Israel’s Oramed Pharmaceuticals said on Wednesday its Oravax Medical unit signed a deal with Vietnam’s Tan Thanh Holdings for the pre-order of 10 million doses of its oral COVID-19 vaccine that is in clinical trials.

The agreement gives Tan Thanh, a drug distributor, the right to sell Oravax’s oral vaccine in development throughout the Association of Southeast Asian Nations (ASEAN), which includes Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam, Oramed said.

“The parties have agreed to negotiate follow-on orders potentially worth hundreds of millions of dollars,” it said, adding the ASEAN region has a prospective patient population of about 660 million.

Nadav Kidron, chief executive of Oramed, said its oral COVID vaccine is undergoing Phase I clinical trials and results should be available in early 2022. The vaccine has been shown to work in animal tests, he said.

As a Communist country, Kidron said, Vietnam could decide on a short Phase II trial and then give emergency authorization. “Potentially, marketing could be very, very fast,” he told Reuters.

As long as Phase I results are as expected, Kidron believes more countries will be interested since the new technology is not likely to require as many boosters as current vaccines. “The idea is that you take it and that’s going to be your dosing and you’re done,” he said.

Last week, Nikki Fried, Florida’s Agriculture Commissioner, said that given the rapid spread of the Omicron variant, she was pushing the U.S. Food and Drug Administration to accelerate the review of oral vaccines as an alternative to injections.

“Countries like the U.S. and Israel (which uses the Pfizer vaccine) … may end up being behind because if developing countries step up their game they may be having the newest technologies available to them before the Western world,” Kidron said.

The post The Algemeiner: Israel’s Oramed Gets Vietnam Pre-Order for 10 Million COVID-19 Vaccine Doses appeared first on Oravax.

Oravax’s oral vaccine should offer critical advantages, including logistics, distribution and delivery in less vaccinated regions, including Africa

NEW YORK, Dec. 14, 2021 /PRNewswire/ — Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced today that its subsidiary, Oravax Medical Inc. (www.ora-vax.com), has screened and enrolled the first participant in a Phase 1 clinical trial of its oral virus-like particle (VLP) COVID-19 vaccine in Johannesburg, South Africa. The open-label trial anticipates enrolling 24 participants who have not received either a COVID-19 vaccine or contracted the virus. Participants will be administered one dose of the oral vaccine at the beginning of the trial and a second dose three weeks later. The trial’s endpoints will include safety and tolerability as well as efficacy by measuring the presence of an immunogenic response.

Oravax’s oral VLP vaccine 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 COVID-19 virus. Oravax’s VLP vaccine technology is highly scalable for manufacturing and is easily transferable for logistical wide scale distribution as there is no need for subfreezing storage.

“We expect to rapidly complete this study and hope to advance into pivotal trials for emergency use approval in countries where our oral VLP vaccine would have the greatest impact. South Africa is a great location for the Phase 1 study, as it is currently experiencing a surge in COVID cases and has struggled to obtain sufficient vaccines. It is our firm belief that an oral vaccine which eliminates syringes and eases distribution and administration, can significantly help increase vaccination rates for South Africa and similar countries,” said Oramed Chief Executive Officer, Nadav Kidron.

About Oravax

Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech, MyMD Pharmaceuticals, 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 (ORMD-0901).

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 development and timing of an oral COVID-19 vaccine, the pace of studies and trials for such oral vaccine and the potential effectiveness, safety, scalability and other advantages of the vaccine or the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes. 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
Zach Herschfus
+1-844-9-ORAMED
Zach@oramed.com

The post Oramed Subsidiary Oravax Announces First Participant Enrolled in Phase 1 Oral COVID-19 Vaccine Trial in South Africa appeared first on Oravax.

– The new partnership builds on the respective strengths of Oravax Medical and Genomma Lab to create compelling value for both companies and their stakeholders

– Press conference with Nadav Kidron, CEO of Oramed & Chairman of Oravax, and Rodrigo Herrera, Chairman of Genomma Lab, to take place today, Thursday, November 18 at 11:00 am EST

NEW YORK and MEXICO CITY, Nov. 18, 2021 /PRNewswire/ — Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, and Genomma Lab Internacional, S.A.B. de C.V. (BMV: LABB) (www.genommalab.com/en/), a leading pharmaceutical and personal care product company in Latin America with an expanding international presence, today announced the formation of a 50/50 joint venture between Genomma Lab and Oramed’s majority-owned subsidiary Oravax Medical Inc. (www.ora-vax.com) to develop and commercialize Oravax’s oral COVID-19 vaccine candidate in Mexico.

Genomma Lab is expected to contribute resources to the joint venture’s oral COVID-19 vaccine development, as well as clinical, regulatory, and commercial activities in Mexico supported by close strategic cooperation between the two companies. Genomma Lab will leverage its extensive supply chain capabilities, partnerships and market presence in Latin America to support the business development process and vaccine roll-out throughout the region. To align interests and deepen the collaboration, Oramed and Genomma Lab announced their intention to enter into a US$20 million share swap based on the average closing price of their respective shares during the past 15 trading days. Genomma Lab has also committed to participate in a future investment in Oravax.

Nadav Kidron, Oramed CEO and Oravax Chairman, and Rodrigo Herrera, Genomma Lab Chairman, will hold a joint press event today, Thursday, November 18, 2021, at 11:00 am EST.

To view the press event: https://us02web.zoom.us/webinar/register/WN_QTGUI13dTdmWdUFKrg_Tbg

“We are very excited to be partnering with Genomma. The synergies between our respective companies’ core competencies made it clear that the combination of our particular strengths represents a unique and significant opportunity. The winning combination of Oravax’s cutting edge science and Genomma’s exceptional sales and distribution network throughout Mexico and Latin America, as well as their local regulatory expertise, results in a powerful venture,” stated Nadav Kidron CEO of Oramed and Chairman of Oravax.

Rodrigo Herrera Chairman of Genomma Lab, commented, “The joint venture announced today represents a unique opportunity for Genomma and its stakeholders. We are thrilled to be forming this strategic alliance with Oramed to bring Oravax’s next-generation oral vaccine and booster candidate once developed and authorized, to Mexico and potentially throughout Latin America to protect our populations from the COVID-19 virus. Based on our initial discussion with the authorities, we are already beginning to prepare for a Phase 2 trial immediately upon successful completion of the Phase 1 trial of the oral vaccine in South Africa. Oravax’s oral vaccine’s superior target profile makes it an ideal candidate for an expedited approval process (Emergency Use Approval). We are excited to play a pivotal role in bringing this revolutionary solution to a vaccine market of an estimated 662 million Latin Americans. Our partnership with Oravax is therefore closely aligned with Genomma’s mission to empower people in 20 countries throughout the Americas to have excellent health and well-being.”

Oravax’s oral VLP vaccine in development targets three SARS CoV-2 virus surface proteins, including proteins less susceptible to mutation, thus making the oral vaccine potentially more effective against current and future variants of the COVID-19 virus. If approved, it would be used either as a standalone or as a booster for previously vaccinated individuals. The oral method of administration may result in greater safety by reducing potential side effects. Oravax’s VLP vaccine technology is highly scalable for manufacturing and is easily transferable for wide scale logistical distribution as there is no need for freezer storage.

About Genomma Lab Internacional

Genomma Lab Internacional S.A.B. de C.V, is a leading pharmaceutical and personal care products company in Mexico with an increasing international presence. Genomma develops, sells, and markets a broad range of premium branded products, many of which are leaders in their categories. The company operates in 20 countries in the Americas, selling over 50 brands through more than 300,000 points of sale.

Genomma Lab’s shares are listed on the Mexican Stock Exchange under the ticker “LAB B” (Bloomberg: LABB:MM). For more information, please visit www.genommalab.com/en/

About Oravax

Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech, MyMD Pharmaceuticals, 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 (ORMD-0901). For more information, please visit www.oramed.com

The securities of Oramed and Genomma described herein have not been registered under the Securities Act of 1933, as amended, and may not be sold in the United States absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

Forward-looking statements: This press release contains forward-looking statements. For example, Oramed, Oravax and Genomma are using forward-looking statements when they discuss the potential for the Joint Venture to create value for the companies and their stakeholders, the expected contributions of each party to the Joint Venture, the expected investments of Oramed and Genomma in each other and of Genomma in Oravax, the potential development and commercialization of an oral COVID-19 vaccine, the ability of such a vaccine to drive business development in Latin America, the pace of studies and trials for such oral vaccine and the potential benefits and safety attributes of the vaccine. 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, Oravax and Genomma 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 product candidates; competition from other pharmaceutical or biotechnology companies; the ability to meet the conditions to complete the share swap and the 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 clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of technology as the companies progress further and lack of acceptance of their methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties that may develop with the companies’ processes; 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; patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed, Oravax or Genomma to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, the companies undertake 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 Contacts

Josh Hexter
Oramed Pharmaceuticals
+1-844-9-ORAMED
josh@oramed.com

Barbara Cano
Genomma Lab Internacional
+1-917-861-2530
barbara@inspirgroup.com

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SOURCE Oramed Pharmaceuticals

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Written ByPress Trust Of India

Oravax Medical Inc, a subsidiary of US/Israeli pharmaceutical company Oramed, has started the first phase of the clinical trial of its oral COVID-19 vaccine in South Africa.

South Africa has been struggling with its plans to achieve herd immunity through vaccinations, with widespread vaccine hesitancy, largely fuelled by social media misinformation.

There is also a strong anti-vaccination lobby, including some political parties.

“We expect to rapidly complete this study and hope to advance into pivotal trials for emergency use approval in countries where our oral Virus-Like Particles (VLP) vaccine would have the greatest impact,” Oramed Chief Executive Officer Nadav Kidron said in a statement.

“South Africa is a great location for the Phase 1 study, as it is currently experiencing a surge in COVID cases and has struggled to obtain sufficient vaccines.

“It is our firm belief that an oral vaccine which eliminates syringes and eases distribution and administration, can significantly help increase vaccination rates for South Africa and similar countries,” Kidron said.

The open-label trial involves participants who have not received either a COVID-19 vaccine or contracted the virus. Participants will be administered one dose of the oral vaccine at the beginning of the trial and a second dose three weeks later.READ | How a Kennedy built an anti-vaccine juggernaut amid COVID-19

The trial’s endpoints will include safety and tolerability as well as efficacy by measuring the presence of an immunogenic response.

Kidron said the trial phase would be short to show as quickly as possible that this oral vaccine works very well on humans before seeking phase two approvals.

Oravax said its oral vaccine 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 COVID-19 virus.

“Oravax’s VLP vaccine technology is highly scalable for manufacturing and is easily transferable for logistical wide scale distribution as there is no need for subfreezing storage,” it added.

Oravax Medical Inc. was established earlier this year by Oramed Pharmaceuticals and other shareholders with a mission to bring an oral COVID-19 vaccine to the market.

Trial of new oral drug against COVID-19 commences in South Africa (republicworld.com)

The post RepublicWorld: Trial Of New Oral Drug Against COVID-19 Commences In South Africa appeared first on Oravax.

By Abigail Klein Leichman  NOVEMBER 23, 2021, 10:56 AM

Current Covid-19 vaccines are delivered via a shot in the arm – nobody’s favorite way to receive any medication – and must be kept at ultracold temperatures.

Oravax Medical, a subsidiary of Israel’s Oramed Pharmaceuticals, has a vaccine candidate that is given by mouth and doesn’t require freezer storage.

On November 18, Oravax announced a partnership with Genomma Lab Internacional www.genommalab.com/en/ in Mexico to develop the vaccine for use in Latin America initially.

Oravax’s oral VLP vaccine candidate targets three SARS-CoV-2 virus surface proteins, including proteins less susceptible to mutation, thus making the oral vaccine potentially more effective against current and future variants of the coronavirus.

If approved, it would be used either as a standalone or as a booster for previously vaccinated individuals. The oral method of administration may result in greater safety by reducing potential side effects.

The two public companies agreed to a $20 million share swap, and Genomma Lab also committed to participate in a future investment in Oravax.

“We are very excited to be partnering with Genomma. The synergies between our respective companies’ core competencies made it clear that the combination of our particular strengths represents a unique and significant opportunity,” said Nadav Kidron, CEO of Oramed and chairman of Oravax. “The winning combination of Oravax’s cutting edge science and Genomma’s exceptional sales and distribution network throughout Mexico and Latin America, as well as their local regulatory expertise, results in a powerful venture.”

Rodrigo Herrera, chairman of Genomma Lab, said, “We are already beginning to prepare for a Phase 2 trial immediately upon successful completion of the Phase 1 trial of the oral vaccine in South Africa. We are excited to play a pivotal role in bringing this revolutionary solution to a vaccine market of an estimated 662 million Latin Americans in 20 countries.”

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Oramed Pharmaceuticals Inc. won approval to run an initial clinical trial for its orally delivered Covid-19 vaccine candidate in South Africa.

The U.S.-listed company has been given permission by the South African Health Regulatory Products Authority to start enrolling patients in Phase 1 of tests, it said in a statement on Friday. A similar trial is planned in Israel and a Phase 2 trial in the U.S., Nadav Kidron, Oramed’s chief executive officer, said in an interview. 

While South Africa has hosted a number of Covid-19 vaccine trials, this would be the first of an oral treatment. Delivery by mouth would surmount some hurdles confronting Africa, such as the need to keep injectable shots refrigerated, sometimes at ultra-low temperatures, in the effort to improve inoculation in the least-vaccinated continent.

“South Africa is the first place in the world we are running a clinical trial” for this vaccine, Kidron said. The dose produced by Oramed’s subsidiary, Oravax, uses a “virus-like particle” to target three of Covid-19’s surface proteins, including those less susceptible to mutation. That, the company said, could make it more effective against future variants of the coronavirus.

Eliminating Barriers

“Oravax’s oral Covid-19 vaccine candidate could offer an exciting potential solution to the Covid pandemic, whether as a booster or for the unvaccinated,”  Kidron said in the statement. The oral form “would eliminate several barriers to rapid, wide-scale distribution, potentially enabling people to administer the vaccine themselves at home,” he said. 

While the tablets may need to be refrigerated, the hope is that the trials will show that the vaccine is stable at room temperature, he said. Emergency-use approval in countries such as Mexico and Vietnam could be sought in the second half of next year, he said. 

The tablets will be “way cheaper” than shots produced by Moderna Inc. and Pfizer Inc. and there will be savings as medical professionals won’t be needed to administer them, he said. Tablets also generally have less side effects than injections, Kidron added.

Published by: Oramed to Start Oral Covid-19 Vaccine Trial in South Africa – Bloomberg

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Oravax’s virus-like particle (VLP) vaccine technology 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 COVID-19 virus. Oravax’s VLP vaccine technology is highly scalable and easily transferable. 

“We believe that Oravax’s oral COVID-19 vaccine candidate could offer 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.

For more information on Oravax’s VLP technology view the video: https://www.youtube.com/watch?v=98ZZctr4vZI

About Oravax

Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech, MyMD Pharmaceuticals, 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 Inc. (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 capsulefor 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 Oravax’s vaccine to be more effective against current and future variants of COVID-19, the potential for future trials or potential emergency approval for Oravax’s vaccine, the potential for Oravax’s vaccine to be taken at home or the potential of ORMD-0801 to be the first commercial oral insulin capsule for the treatment of diabetes. 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

Joshua Hexter

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

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