Vaxine Pty Ltd: An Overview

Vaxine Pty Ltd, an Australian biotechnology company headquartered in Adelaide, South Australia, specializes in developing vaccines and immunotherapies. Founded in 2002 by Professor Nikolai Petrovsky, a prominent immunologist at Flinders University, Vaxine spun off from the National Health Sciences Centre in Canberra. Based within the Flinders Medical Centre/Flinders University precinct in Bedford Park, it employs 11-50 staff and generates an estimated $6.3M in annual revenue (2024).

Core Focus and Technology

Vaxine is renowned for its proprietary Advax™ adjuvant platform, a polysaccharide-based technology that enhances vaccine effectiveness without relying on traditional adjuvants like aluminum. This platform drives its pipeline, targeting infectious diseases (e.g., hepatitis B, influenza, COVID-19), allergies, and cancers. The company leverages cutting-edge methods, including artificial intelligence, in drug design and clinical evaluation—a standout example being CpG55.2, one of the first AI-designed molecules to enter human trials (2019) and gain vaccine approval (2021, outside the U.S.). Over $32.7M in funding from the U.S. National Institutes of Health (NIH) since 2008 has been instrumental in advancing Advax™, supporting basic research, adjuvant discovery, and vaccine development across four major awards.

Swine Flu Vaccine (2009) Vaxine gained global recognition as the first company to launch human trials for a swine flu (H1N1) vaccine during the 2009 pandemic, partnering with U.S.-based Protein Sciences. This milestone, underpinned by early Advax™ work, earned Vaxine the “Coolest Company” title at the 2010 Anthill Cool Company Awards and a 2011 Vaccine Industry Excellence Award. The NIH’s $8.39M award (2008–2013, HHSN272200800039C) for basic biomedical research likely supported this effort, refining Advax™ ahead of and during the trials.

COVID-19 Vaccine (SpikoGen®) SpikoGen®, the commercial name for Vaxine’s COVID-19 vaccine, uses a spike protein antigen produced via insect cell expression systems, combined with the Advax™ adjuvant featuring CpG55.2. This polysaccharide-based immune enhancer boosts efficacy without traditional adjuvants like aluminum, distinguishing it in the vaccine landscape. Authorized for emergency use in Iran in October 2021 for adults (later extended to children 5+), SpikoGen® also received a provisional determination from Australia’s Therapeutic Goods Administration (TGA) in June 2022, pending full approval. NIH funding was pivotal: the $11.28M Adjuvant Discovery Program (2014–2021, HHSN272201400053C) included $500,000 for COVID-19 in 2020, while the $6.37M vaccine candidate award (2018–2023, 75N93018C00024) provided $4.15M in outlays, aligning with SpikoGen®’s development for emerging infectious diseases.

Pipeline Beyond influenza and COVID-19, Vaxine’s pipeline includes vaccines for Japanese encephalitis, West Nile virus, malaria, HIV, rabies, and more. The NIH’s $6.69M Adjuvant Development Program (2018–2025, 75N93018C00044), with $3.95M outlayed to date, sustains this work, building on earlier awards to optimize Advax™ for diverse applications.

Funding and Partnerships

Vaxine’s funding blends Australian and international support:

Australian Government: Seed funding from AusIndustry’s Biotechnology Innovation Fund and $1M from the Medical Research Future Fund (MRFF) in 2020–2021 for COVID-19 work, matched by $4.8M from partners (e.g., Pall, Oracle, University of Sydney).

U.S. NIH: Over $32.7M across four awards: $8.39M (2008–2013) for basic biomedical research, likely foundational to Advax™ and the swine flu vaccine. $11.28M (2014–2021) for the Adjuvant Discovery Program, advancing CpG55.2 and SpikoGen®. $6.69M (2018–2025) for ongoing adjuvant development, with $3.95M outlayed. $6.37M (2018–2023) for vaccine candidates, with $4.15M outlayed, targeting biodefense and emerging diseases like COVID-19.

Philanthropy: No direct ties to the Bill & Melinda Gates Foundation, Clinton Foundation, or Wellcome Trust are evident.

Context and Current Status

While not rivaling Biota’s $95.6M HHS contract, Vaxine’s $32.7M+ from NIH underscores its global relevance. SpikoGen®’s rollout in Iran and TGA eligibility highlight Advax™’s impact, though a $13,320 TGA fine in June 2022 for unapproved vaccine advertising signals regulatory challenges. The ongoing NIH award (to 2025) positions Vaxine as a key player in Australia’s biotech scene, leveraging Flinders University ties and international collaboration.

The Fine

Vaxine Pty Ltd was fined $13,320 by the Therapeutic Goods Administration (TGA) in June 2022 for allegedly advertising an unapproved COVID-19 vaccine, in breach of the Therapeutic Goods Act 1989. This penalty stemmed from promotional content posted on platforms like Facebook and YouTube, related to its vaccine candidate, SpikoGen® (also known as COVAX-19), which at the time had not been approved for use in Australia. The TGA prohibits advertising unapproved therapeutic goods to the public, including those under clinical trial, unless the information is strictly factual, balanced, and doesn’t promote use or supply—a line Vaxine apparently crossed.

Conclusion

Vaxine Pty Ltd represents a notable presence in Australian biotechnology, with its Advax™ platform supported by over $32.7M in NIH funding since 2008. This investment has contributed to projects such as the 2009 swine flu vaccine and SpikoGen®, alongside the development of AI-driven CpG55.2 and a pipeline targeting various diseases. Operating from Adelaide with ties to Flinders University, Vaxine combines local foundations with international partnerships, distinct from philanthropy-driven initiatives like CEPI. Its trajectory prompts consideration of how Australia manages biotech talent in the context of foreign funding.

Sources:

CONTRACT to VAXINE PTY LTD | USAspending

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