Vaxine Pty Ltd, a clinical-stage biopharmaceutical company based in Australia, specializes in the adjuvant platform technology, behind COVAX-19®, the first COVID-19 vaccine to be developed in the Southern Hemisphere is set to enter human trials.
The Phase 1 trial will show the initial data and efficacy of the vaccine, COVAX-19®. The trial will be conducted by the PARC clinical trial unit at the Royal Adelaide Hospital, the vaccine will be tested in a total of 40 healthy subjects that are aged between 18 years to 65 years who have met the required criteria for the test.
The subjects will be receiving the vaccine in two doses within three weeks apart, they will then be placed in a blood test to measure the protective antibody and T cell responses induced by the vaccine.
Vaxine’s Chairman and Research Director, Professor Nikolai Petrovsky said that ever since they have identified COVID-19 as a major pandemic, they have started in developing a vaccine against the novel virus as early as January.
He added that despite being a small company, using their 18 years of expertise they have learned to be resourceful especially against major pandemics such as SARS, swine flu, bird flu and Ebola of which they have been designing pandemic vaccines that were effective in animal studies, as well as having some enter human clinical trials.
By February, Vaxine had already rapidly developed a variety of different COVID-19 vaccines, including DNA, mRNA, and recombinant protein kinds however, they have quickly concluded that the recombinant spike protein approach provided the precise and reliable results when combined with their unique non-inflammatory Advax-CpG55.2 adjuvant.
Professor Nikolai Petrovsky explained that their experience with adenovirus-based vaccines has shown disappointing immunity and high toxicity, and DNA and mRNA type vaccines can result in poor scalability or have an unexpected side effect of which could cause major problems when it comes to COVID-19 where a strong and long-lasting immunization is needed. Thus, Vaxine chose to develop it’s COVAX-19® vaccine through a recombinant spike protein approach where it shows exceptional safety, tolerability, manufacturing scalability, and a proven regulatory pathway.
Vaxine has extensive experience with pandemics, back in 2009 they managed to develop a new swine flu vaccine in human trials in 3 months of discovery of the virus and in 2019, they have developed the first vaccine technology using artificial intelligence to enter human trials.
Their adaptation of new technologies in the designing of vaccines has enabled them to develop pandemic vaccines more efficiently and faster.
National Institute of Allergy and Infectious Diseases have supported the development and discovery of the critical Advax-CpG55.2 adjuvant platform, forming the basis for COVAX-19® and funded through Federal funds under NIAID Contracts HHSN272200800039C, HHSN272201400053C, and HHSN27221800024C.
Professor Petrovsky explains that strong financial support is needed to build a robust pandemic platform and advance it into human trials.
Vaxine’s business manager added that the success with their current development milestone could not have come fruitful without the long-term support they have received from many of their key partners.