Since the start of the COVID-19 pandemic, scientists at the University of Georgia’s Center for Vaccines and Immunology have been working tirelessly under the leadership of Dr. Ted Ross, an infectious disease and vaccine development expert. With an intense focus on a “universal” flu vaccine for influenza, Ross and team quickly pivoted to join the fight against COVID-19. By late March, the Athens Georgia-based team was already testing multiple vaccine candidates in the hope of progressing to clinical trials. One such preclinical vaccine project centered on what has emerged as an investigational COVID-19 vaccine product called COVAX-19.® The collaboration made progress based in part on a robust underlying platform developed in collaboration with the National Institutes of Health (NIH) known as Advax. Both COVAX-19 and the underlying Advax belong to a Flinders University spin-off called Vaxine Pty Ltd. The Adelaide, South Australia-based firm announced they would target a commercial vaccine for COVID-19 by early 2021. Is this possible? This merited a preliminary review.
UGA & Vaxine Collaboration
TrialSite News first started following Dr. Ted Ross and the team at the University of Georgia (UGA) Center for Vaccines and Immunology back in late March as various teams around the US. And beyond initiated research into COVID-19. A leading pandemic vaccine center, UGA has been collaborating with South Australia-based vaccine developer Vaxine to assist with the validation of the COVAX-19® investigational vaccine product. An esteemed vaccine research center, the “University of Georgia has one of the largest high-security ferret challenge facilities in North America, making it the ideal site to conduct such vaccine efficacy studies” reported Dr. Ross recently.
Preclinical Research Results
Now after months of preclinical research at the Athens Georgia-based lab, Vaxine reported that the University of Georgia successfully completed immunizations of ferrets with COVAX-19® vaccine with no reports of any adverse reactions. Now the next step in the preclinical research effort will be for the immunized ferrets to be challenged with COVID-19 virus to assess their protection, with this work scheduled to occur over the next month.
The Investigational Product & Underlying Platform
COVAX-19® is based on Vaxine’s Advax™ platform, described on the company’s website as a novel sugar-based adjuvant technology that enhances antibody and T-cell immune responses against co-administered antigens. Unique in its lack of reactogenicity or pyrogenicity, Advax is actually the first anti-inflammatory adjuvant. Professor Petrovsky, head of Vaxine and a professor at Flinders University, and team have demonstrated that it suppresses interleukin 1 gene expression by murine and human immune cells. The Advax adjuvant technology strongly stimulates both T cell and antibody responses when combined with SARS-CoV-2 spike protein.
In explaining why Advax adjuvant technology is a “game changer,” Professor Petrovsky reported, “Advax is the first anti-inflammatory adjuvant. Hence unlike the problems of high fevers, fatigue and muscle aches commonly seen with vaccines based on adenovirus vectors or mRNA or formulated with traditional inflammatory adjuvants, COVAX-19® vaccine should be free of any such inflammatory side effects.”
Developed in Collaboration with NIH
The U.S. National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID), helped develop Advax via its Adjuvant Discovery and Development Program. These and other grants aided the Flinders University spin-off that still maintains an office on campus in the Flinders Medical Center in Bedford Park.
Remaining Preclinical Animal Studies
Sharing some clues in regards to timelines, the company’s Business Manager, Sharen Pringle, reports that “The current animal studies which will report over the next 2 months should demonstrate the superiority of COVAX-19® vaccine in protecting against COVID-19 infection.” Ms. Pringle went on that “Our expectation is that COVX-19® vaccine will not only provide superior and long-lasting protection but will also provide superior safety and tolerability.”
Track Record & Potential for All Ages
The company notes in a recent press release its pandemic vaccine platform’s proven track record and its confidence in the ability for rapid manufacturing at scale; with a 20-year track record involving the development of state-of-the-art vaccines against pandemic influenza, SARS and MERS coronaviruses, could this be the window of opportunity for Vaxine to emerge as another COVID-19 vaccine contender?
The platform has been tested in previous studies, explained Professor Petrovsky. For example, “Through the use of Advax adjuvant in previous pandemic influenza vaccine clinical trials, we have shown it is possible to produce protective immune responses even in subjects 90 years of age and older, an age group where most other vaccine technologies including adenovirus vectors are almost certain to fail.”
“Right now the world needs COVID-19 vaccines that are effective across all age groups and particularly in the elderly in order to bring this pandemic to a rapid end. That is exactly the role that Advax™ adjuvant was designed for,” Professor Petrovsky concluded.
Professor Petrovsky reports that a Phase I clinical trial of the COVAX-19 vaccine are scheduled to commence soon, with early results by September and Phase 2/3 clinical trials planned for Q4 2020. Assuming each step along the way goes as planned (and that’s a big assumption), the company could potentially be ready for market by early 2021. Based on the fact that the company reports it has at least another month of animal study plus the natural delays that can occur in the overall process, not to mention regulatory filings to commence studies, TrialSite News suspects the timelines may be overly aggressive but certainly appreciate the spirit and intentions.
The Australian-based venture engages with multiple international partners from the University of Georgia, where they are collaborating on the testing and development of COVAX-19, to other commercial partnerships such as Ireland-based APC.
APC and Vaxine signed a deal to accelerate the development and launch of the COVAX-19 vaccine candidate. APC, founded in 2011, was set up to partner with drug development organizations and leverage its BioACHEIVE™ to expedite how drug manufacturing processes are researched and developed. Vaxine will leverage APC to drive process optimization of spike protein production, a critical ingredient in COVAX-19 vaccine.
In addition to the company’s internal funds and the creative leveraging of partnerships, Vaxine reports that it has been able to count on support from a Fast Grant from Emergent Ventures, the Mercatus Center, George Mason University.
Vaxine Pty Ltd
Vaxine was incorporated in 2002 as a private Australian biotechnology company focused on development of innovative vaccines based on its unique Advax™ vaccine adjuvants. Vaxine has successfully developed vaccines against seasonal and pandemic influenza, hepatitis B, Japanese encephalitis, and West Nile Virus. In addition to its infectious disease focus, Vaxine has divisions focused on cancer immunotherapy and allergy (Mylexa Pty Ltd). Vaxine also has a veterinary division, Vetvax Pty Ltd, that supplies vaccine adjuvants for animal health vaccine applications and is also commercializing a canine cancer vaccine.
Ted M. Ross, PhD, Director of the Center for Vaccines and Immunology and Georgia Research Alliance Eminent Scholar and Professor of Infectious Diseases
Nikolai Petrovsky, PhD, Professor, Flinders University
Call to Action: TrialSite News will monitor the progress of Vaxine based on declared timelines. With a distributed franchise manufacturing model, Vaxine seeks to partner with contract manufacturers and pharmaceutical companies on a country by country basis. This novel approach in the world of vaccine development offers individual countries considerable flexibility and autonomy with a technology transfer.