EnGeneIC Limited, an Australian, Sydney-based biotechnology company, has developed a globally unique nanocellular technology that in pre-clinical animal studies has been shown to stimulate a broad and powerful anti-COVID-19 immune response and also neutralises the known mutant COVID-19 viruses of concern, particularly the delta variant.
EnGeneIC has commenced a Phase I clinical trial dosing healthy adults at St Vincent’s Hospital, Melbourne using its patented nanocell technology platform (EDV™; EnGeneIC Dream Vector). The trial will test for safety and a plethora of anti-COVID-19 immune responses.
The EDVs have been packaged with three unique molecules,
a) one that produces the COVID-19 virus Spike protein in the EDV nanocell, thereby stimulating a strong antibody response,
b) a second molecule that simultaneously triggers the activation of important cells of the immune system, involved in virus-fighting, and
c) a third molecule that transforms the anti-virus antibody response into “high affinity” Velcro like antibodies that neutralise the mutant COVID-19 viruses.
While the company is able to quickly modify the payload in EDVs to produce mutant Spike protein variants, most importantly, the existing COVID-19-EDV already shows high neutralising antibody levels in pre-clinical animal studies against the “COVID variants of concern” and can neutralize the delta variant at more than 95%. The pre-clinical studies show that the antibodies generated, completely neutralise the Spike protein from major variants being alpha (U.K.), beta (South African), gamma (Brazil) and critically the delta (Indian) variant. A seminal publication on the preclinical studies is in preparation for a major scientific journal.
Drs. Jennifer MacDiarmid and Himanshu Brahmbhatt, co-CEOs of EnGeneIC, are primarily developing the EDV technology for cancer treatment, but say that this approach to COVID-19 became obvious to them since patients with late-stage cancer in the company’s current cancer clinical trials have responded to EDV treatment with the development of a robust immune response even though they have a severely compromised immune system. Additionally, being able to produce antibodies is only part of the story, as an anti-cancer and anti-viral immune response requires the induction of chemicals called interferons to activate the patient’s own virus fighting T cells and to create a memory antibody response.
“We appreciate that the vaccine rollout is ongoing in Australia, but no vaccine to date is directed towards immune-compromised people, and these people were excluded from vaccine trials aimed at obtaining emergency approval. People with cancer, auto-immune diseases, chronic diseases, or even older individuals have a degree of immune-deficiency and are not likely to respond effectively to current vaccines. Our cancer clinical trials show positive outcomes including improved anti-cancer immunity for those with end stage cancers. These trials also show that our treatment is very safe since it does not harm healthy cells, and in fact, it is ground-breaking in that it results in activation of healthy white blood cells (immune cells) in these vulnerable patients.”
Following the initial safety trial, the COVID-19-EDV is designed as a vaccine for people who are particularly vulnerable to COVID-19 because they have compromised immune systems and may not respond effectively to existing vaccines. A US-based hospital conglomerate is working with EnGeneIC to expediate a clinical trial in the United States to test the COVID-19-EDV in this same immune-compromised group. Since the COVID-19-EDV produces virus-neutralising antibodies against all variants tested so far including delta it could be added to the follow-up vaccine schedules that will be required as the pandemic progresses.
Additionally, the currently used vaccines have to be stored and transported at -20ºC to -70ºC, or be refrigerated and have a shelf life of 3 to 6 months. EnGeneIC’s COVID-19-EDV vaccine is stored at room temperature and currently has a shelf life of over three years, making it easily transportable to rural and remote regions throughout the world. Importantly there are no chemical additives or stabilisers in the COVID-19 EDV vaccine.
The St. Vincent’s COVID-19-EDV trial with Professor Kumar Visvanathan as the Principal Investigator has commenced in Melbourne with two people being safely dosed so far, and is seeking healthy non-vaccinated adult volunteers. Immune readouts are expected at 1 month and 3 months after dosing.
About EnGeneIC and the EDV™ Nanocell Technology
EnGeneIC is a clinical stage biopharmaceutical company advancing its proprietary bacterially-derived EDV™ (EnGeneIC Dream Vector) nanocells as a powerful nanoparticle drug, siRNA, or miRNA delivery platform designed to directly target and effectively kill tumor cells with minimal toxicity, while simultaneously stimulating the immune system’s innate and adaptive anti-tumor response. EnGeneIC is now in Phase 2a clinical trials in patients with intractable cancers, including patients with metastatic pancreatic cancer. EnGeneIC is currently planning to commence further clinical trials in Australia and USA. The company was recognized as the Most Innovative Company in Drug Delivery by FierceBiotech and FiercePharma for 2019, and Australian Financial Review’s most Innovative Company and Innovative Program in Healthcare in 2019. EnGeneIC was also featured in the December 2019 issue of InsightsCare magazine as “The Top 10 Nanotech Companies to Watch.