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:
- Primary and secondary endpoints of safety and immunogenicity met;
- Oral vaccine elicited a potentially protective IgG response with significant seroconversion from baseline;
- Trial shows proof of concept for oral delivery of vaccines using Oravax technology;
- Significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune response to VLP vaccine antigens observed in the majority of the patients dosed;
- No safety issues were 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. Oramed Pharmaceuticals‘ POD™ protects orally delivered peptide- and protein-based drugs to survive the digestive system while enhancing their absorption across intestinal membranes and into the bloodstream. Premas’s D-Crypt technology is used to make a variety of “difficult to express” proteins in sizeable quantities efficiently.
Oravax’s oral vaccine should offer critical advantages, including logistics, distribution, and delivery in less vaccinated regions. If approved, the oral vaccine could be used as a standalone or as a booster for previously vaccinated individuals. As the oral VLP COVID-19 vaccine continues to be developed as both a first-line and booster vaccine, Oravax is being positioned to address the broader global vaccine market and opportunities for additional vaccine indications are being explored. The vaccine market is projected to reach $125 billion by 2028.
An oral pill eliminates a lot of challenges with current vaccines. Current vaccination efforts are hampered by the need to keep vaccines at freezing temperatures and to have qualified people to administer the shots. The oral vaccine would not have to be kept below freezing temperatures or administered at central locations. The oral vaccine eliminates the bio-hazardous waste problem. People would be able to take the pills from the comfort of their homes. The majority of humanity would finally be able to get an inexpensive, easy-to-administer COVID vaccine. An oral vaccine could pave the way to a pandemic-free world because the most vulnerable people could be quickly vaccinated.
The Phase 1 clinical trial of Oravax’s oral virus-like particle (VLP) /COVID-19 vaccine took place in South Africa, using COVID-naive participants. The trial protocol called for two cohorts, each comprised of 12 participants. The South African Health Products Regulatory Authority (SAPHRA) requires a 42-day safety waiting period once the last patient in Cohort A completes enrollment and dosing, after which Cohort B may commence enrollment and dosing. South Africa was chosen because of the low incidence of the population having taken any form of COVID vaccine and because they have a world-class clinical trials infrastructure.
“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 evaluated the safety, tolerability, and immunogenicity of two concentrations of the 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 included an additional 12 subjects (subjects 13-24) who received a high dose on day 1 and a second dose on day 21.
Subjects were monitored for safety, tolerability, and antibody titers for a period of 24 weeks after the first dose administration. An end-of-trial visit took place 24 weeks after the first dose.
About Oravax
Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals, 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.
Company Contact: Zach Herschfus Tel: +1-844-9-ORAMED zach AT oramed.com
About Premas Biotech
Premas Biotech develops novel technologies and partners with global biopharmaceutical companies to build and develop novel biotherapeutic and vaccine candidates. Premas’ key focus areas are infectious diseases, cancer, metabolic disorders, and inflammation. Besides D-Crypt™, the difficult-to-express protein expression platform, Premas’ leading technologies include Axtex-4D™, an ex-vivo tissuoid generation platform, and C-Qwence™, a fully human naive India-based scFv antibody library.
For more information please visit www.premasbiotech.com
SOURCE: Csion PRnewswire Oct 7, 2022
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