Oramed Subsidiary Oravax Reports Positive Preliminary Phase 1 Data for its Oral Covid-19 Vaccine
VaccineAntibodyClinical Result
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.
"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
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.
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