EnGeneIC publishes the COVID-EDV vaccine’s novel mechanism of action in a leading Immunology journal

2023-01-31

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Protects against mutant strains Promotes a long term memory response No side effects in healthy volunteers Vaccine stored and transported at room temperature with long shelf life Seeking immune-compromised patients for next human trial SYDNEY, Australia and NEW YORK, Jan. 31, 2023 (GLOBE NEWSWIRE) -- The completely unique mechanism of action of the world’s first COVID-19 vaccine to stimulate “high affinity” antibodies which neutralise most COVID variants has been published by EnGeneIC in the prestigious journal, Frontiers in Immunology (27th January, 2023). This paper illustrates that the COVID-EDV vaccine is a fundamental change in thinking on how to produce an effective and inexpensive vaccine and has broad-reaching ramifications for vaccinology. EnGeneIC, an Australian clinical stage biotechnology company, has developed therapeutics for end stage patients with low survival cancers based on its revolutionary and world first EDV™ nanocell cyto-immunotherapy platform (EDV; EnGeneIC Dream Vector). More recently, the company discovered that the same EDV nanocell can deliver viral antigens, resulting in its novel COVID-EDV vaccine. The paper describes for the first time in mice and humans, that EDVs packaged with Spike-protein and a glycolipid, stimulate an alternate anti-viral immune pathway, differing from all existing vaccines and involving an orchestra of immune cells. COVID-EDV produces high affinity antibodies which strongly latch on to the virus, even when it mutates, whereas other vaccines make low affinity antibodies that only bind to the COVID strain which they are directed against and fall off if the virus has a mutant Spike protein. EnGeneIC’s results indicate that COVID-EDV neutralizes 90-100% of ancestral and variants of concern (VOCs) in mice and in human trial volunteers, including neutralization of Omicron BA 4/5. Blood analysis also revealed long lasting Spike-specific memory B and T cells. EnGeneIC is currently conducting trials of its groundbreaking vaccine in Sydney and Melbourne and has vaccinated 80 volunteers. After two doses, 3 weeks apart, the majority of participants have passed the 3- month post vaccination safety assessment and importantly, they have high affinity antibodies capable of neutralising all COVID mutants, including Omicron. Principal Clinical investigator Professor Kumar Visvanathan from St Vincent’s Hospital, Melbourne, who is a co-author on the paper, noted, “We are very pleased to be part of this study, where healthy volunteers have not been experiencing any side effects and are broadly protected against all the COVID mutant strains. This is an Australian innovation and the Joint CEOs and founders of EnGeneIC, Drs Jennifer MacDiarmid and Himanshu Brahmbhatt have been very persistent in translating this exciting vaccine approach into clinical trials.” In October, 2022, EnGeneIC was announced as the winner of the Australian Financial Review Most Innovative company in Healthcare in Australia and New Zealand, based on the COVID-EDV vaccine’s novel mechanism of action, clinical results and the company’s trials treating late-stage cancer patients who are immune-compromised and where EDVs stimulate a strong immune response. Dr. Brahmbhatt said, “So, rather than compete with Big Pharma, EnGeneIC is targeting the immune-compromised population who don’t respond well to current vaccines and are vulnerable to severe disease and morbidity. Many of these people are too stressed and concerned about the consequences of getting COVID – we strongly believe that we can help. Globally, over 4% of the population including those with cancer, organ transplant, rheumatoid arthritis, those taking steroids and other immune-depressing drugs are immune-compromised and a staggering 20% of those over 70 falls into this category.” Ethics approval has been granted for a COVID-EDV trial in immune-compromised people in Sydney, Melbourne and Perth and volunteers are now being sought for this important trial. Additionally, the vaccine can be stored and transported at room temperature and has more than 18 months shelf-life, making it particularly attractive for remote areas and developing nations where transport and storage is difficult. For more information, images, animations, high-res footage and interviews, please contact ernestine@gemaker.com.au (0411) 691 241 For trial information, please contact COVID-EDV.Trial.Enquiries@engeneic.com About EnGeneIC and the EDV™ Nanocell Technology EnGeneIC is a clinical stage biopharmaceutical company advancing its proprietary EDV™ (EnGeneIC Dream Vector) nanocells for oncology and infectious disease applications. The EDV is a powerful nanoparticle drug, siRNA, or miRNA delivery platform designed to directly target and effectively kill tumour cells with minimal toxicity, while simultaneously stimulating the immune system's innate and adaptive anti-tumour response. EnGeneIC EnGeneIC is now in Phase IIa clinical trials in patients with intractable low survival cancers, including patients with metastatic pancreatic cancer.