Premas Biotech Reports Positive Preliminary Phase-1 Data for its Oral Covid-19 Vaccine, developed for Oravax Medical

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  • Premas Biotech is the developer of the technology for the Covid-19 vaccine and a shareholder in Oravax Medical Inc
  • Primary and secondary endpoints of safety and immunogenicity met
  • Oral vaccine elicited a potentially protective IgG response with significant seroconversion from the baseline
  • Trial shows proof of concept for oral delivery of vaccines using Oravax technology

GURUGRAM, India, Oct. 7, 2022 /PRNewswire/ — Premas Biotech, developer of technologies & bioprocesses for novel proteins, today announced that Oravax Medical Inc., a US-based company that Premas Biotech is a shareholder in, reported positive preliminary data from its Phase 1 trial in South Africa of an oral Covid-19 vaccine candidate.

Preliminary Phase 1 trial results from the first cohort include:

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  • 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
  • was observed in 75% 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 Premas Biotech’s D-Crypt™ Platform with Oramed Pharmaceuticals’ POD™ technology. 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 Study

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 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 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 Premas Biotech

Premas Biotech develops novel technologies & bioprocesses and partners with global biopharmaceutical companies to build and develop novel biotherapeutic & vaccine candidates. Premas’ key focus areas are infectious diseases, cancer, metabolic disorders and inflammation. Besides D-CryptTM the difficult-to-express proteins expression platform, Premas’ leading technologies include Axtex-4D™: an ex-vivo tissueoid generation platform and C-Qwence™: a fully human naive India-based scFv antibody library. Further information is available on the Company’s website: www.premasbiotech.com

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.

Company Contact

Ambar Mehrotra

Cell: +91 8968482266, Ph: +91-124-454 6600

[email protected]

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