COVID-19 vaccine developed by Vaxine Pty Ltd is the first Australian vaccine to reach final Phase 2 and 3 clinical trials
Australian-developed COVAX-19 vaccine made from a synthetic spike protein combined with a unique sugar-based adjuvant turbocharger, has reached a major milestone with recruitment completed for the pivotal Phase 3 trial being conducted in the Middle East. This represents a major milestone for Sypharma, Vaxine, Covaxia, and Cinnagen Corp.
Phase 2 studies in 400 participants showed COVAX-19 was well tolerated and produced promising immunogenicity data. Given these very encouraging studies, manufacturing of the key ingredient, Advax adjuvant, is being scaled up to supply demand for when this vaccine gets Emergency Usage Approval, which could be as early as Quarter 4 this year.
“We are excited to be part of this project that is developing a solution to this global COVID-19 crisis” says the R&D/Technical Manager Dr, Howard Liu of Sypharma, which will be managing the Advax manufacturing scale up.
“This pandemic will only be over when we can offer effective and safe vaccines to every person on the planet” says Sharen Pringle, Business Manager at Vaxine.
“As countries enter their second, third, fourth or even fifth waves, safe and effective vaccines continue to be urgently needed and we have designed COVAX-19 to meet that need”, COVAX-19 developer, Professor Nikolai Petrovsky, Chairman and Research Director of Vaxine, explains.
Vaxine’s Covid-19 technology is the most advanced COVID-19 vaccine candidate developed in Australia. The technology is currently in Phase 3 trials in the Middle East under the tradename Spikogen®, having already successfully completed Phase 1 in Australia and then a Phase 2 trial in the Middle East. The vaccine targets the COVID-19 spike protein and is made using cultured insect cells to produce a synthetic protein. COVAX-19 has been shown to safely produce a protective immune response across multiple animal models.
About Advax Adjuvant
Inulin is a natural plant-derived sugar (polysaccharide) that when crystallized into a stable microcrystalline particulate form known as delta inulin acquires potent vaccine adjuvant activity. Sypharma produces Advax under a Good Manufacturing Practice (GMP) process designed to ensure reproducible particles with consistent size, solubility, and potency. Advax adjuvant has proved successful in human trials of vaccines against seasonal and pandemic influenza, hepatitis B, bee and ant sting allergy and most recently COVID-19.
Vaxine was incorporated in 2002 as an Australian biotechnology company focussed on development of innovative vaccine adjuvant technologies. Adjuvants act as turbo chargers to enhance vaccine effectiveness and Vaxine’s lead product is its Advax inulin adjuvant. With US government funding support, Vaxine has successfully developed a broad range of vaccines and adjuvants. Throughout its history, Vaxine has sought to team up with the most innovative and entrepreneurial partners that share its vision to advance global public health.
About Sypharma Pty Ltd
Sypharma is an Australian speciality contract manufacturing group which was founded in 2005. Sypharma specialises in contract manufacturing products for early clinical to Phase I, II, and III clinical trials, and have a range of multipurpose cleanrooms for the manufacture of injectable, oral or topical drugs and medical devices. Equipped with modern, comprehensive and specialised manufacturing equipment services, Sypharma’s expertise and experience are available to clients seeking the manufacture and packaging of therapeutic goods, veterinary products and consumer items. Licences include accreditation from the TGA, ISO13485 and USFDA. Sypharma manufactures products from R&D through to commercial volumes for both large and small volume parenterals. In addition to contract manufacturing development Sypharma works with partners to innovate and develop new technologies. Notably, Sypharma has been Vaxine’s manufacturing partner all the way from Vaxine’s earliest days engaged in preclinical development of its vaccine adjuvants to today as Vaxine gears up to launch the most important vaccine in its development history.
About Cinnagen Corp
CinnaGen Co. was founded in 1994 with the goal of manufacturing hi-tech products in biotechnology and related fields. Since its start of operation with 4 scientists, CinnaGen has grown to become the biggest bio-pharmaceutical manufacturer and biotech exporter in the Middle East region. The concept was to be active in the research and development of new potent biotech-based products to cover regional markets. Enzymes, molecular biology reagents and PCR kits were the first products and then CinnaGen used its proprietary set of technologies to produce monoclonal antibodies for blood group typing. The next important step for CinnaGen was to produce therapeutic recombinant proteins and monoclonal antibodies area. Cinnagen prides itself on its use of innovative skills to meet health challenges, none more important and pressing than the need for a safe and effective vaccine against COVID-19 vaccine which it is developing with the help of its Australian partners.