How and when did your company start, and where are you located?
Vaxine was founded by Professor Nikolai Petrovsky in 2002, as a spin out of the National Health Sciences Center (NHSC) in Canberra, a translational medicine research organization of which Prof. Petrovsky was Executive Director at the time. Vaxine's initial seed funding was provided by AusIndustry through its Biotechnology Innovation Fund, an early funding scheme established by the Australian government to encourage the establishment of local biotechnology companies based on research of Australian universities. The key intellectual property which Vaxine was founded to commercialise was a polysaccharide-based vaccine adjuvant technology originally conceived by Dr Peter Cooper at the Australian National University and subsequently developed in partnership with Prof. Petrovsky at NHSC into the Advax™ adjuvant platform. In 2004, Prof. Petrovsky was appointed as a Professor at Flinders University in Adelaide and Vaxine's operations transferred with him to Adelaide when he took up this new appointment. Vaxine remains embedded in the Flinders Medical Center/Flinders University precinct in Adelaide, thereby providing it with ideal opportunities to undertake bench to bedside vaccine research and development in a fertile academic and clinical environment.
How many employees do you have, and how do you find and attract them?
Vaxine has approximately 15–20 employees including interns at any one time. These employees are drawn from all over the world, reflecting the global nature of the biotechnology industry. In particular, Vaxine has a very active internship program that regularly draws biotechnology students from Europe and the United States, to spend 6 months gaining work experience within Vaxine's research laboratories. Some interns have subsequently gained employment positions or do PhDs at Vaxine. A major advantage of having such a diverse employee background is that Vaxine has access to native speakers covering almost all of the major languages, greatly facilitating communications with potential partners in these countries and with preparing documents including patents for filing in these jurisdictions.
What are the main focus and platform technology(ies) of your company?
Vaxine was originally founded to develop and commercialise the novel Advax™ polysaccharide adjuvant technology invented by Drs Cooper and Petrovsky. However over the last decade Vaxine significantly expanded its R&D portfolio and has developed a large vaccine pipeline, underpinned by its exceptionally effective Advax™ adjuvant platform. As an acknowledged world leader in the field of vaccine adjuvant development, Vaxine has recently secured an Adjuvant Discovery Program contract from the National Institutes of Health through which Vaxine is developing a range of parenteral and mucosal vaccine adjuvants.
Can you provide a short overview of your product pipeline?
In addition to its Advax adjuvant platform that is already in late-stage human clinical development, Vaxine has a promising internal vaccine platform including a hepatitis B prophylactic vaccine for poor-responder patients with diabetes or chronic kidney disease, a therapeutic hepatitis B vaccine, enhanced efficacy seasonal and pandemic influenza vaccines, a universal influenza vaccine, and a insect sting allergy vaccine, all of which are already in clinical development. In addition, through an extensive range of collaborations and partnerships, Vaxine is involved in development of promising new human vaccines against pneumococcus, typhoid fever, shigella, Japanese encephalitis, West Nile virus, malaria, HIV, tuberculosis, SARS, MERS, anthrax, RSV, HSV2, Ebola, cancer and even Alzheimer disease. Further to this, Vaxine is also involved in partnerships to apply its adjuvant expertise to development of improved veterinary vaccines against influenza, rabies, African horse sickness and peste de petit ruminants, among others. Particular interests of potential relevance to both human and veterinary vaccines are the use of adjuvants to improve vaccine immunogenicity and effectiveness in the very young and the elderly.
Who is your competition, and what advantage(s) do your products / technology offer?
There continue to be extremely limited options in respect of licensed human adjuvants, largely restricted to aluminum based products with a smaller contribution from squalene oil emulsion adjuvants. While many small biotechnology companies have tried to develop and commercialize alternatives by and large these efforts have failed due to the massive regulatory hurdles in demonstrating adequate safety and tolerability adjuvants. Furthermore an adjuvant cannot be licensed in its own right but instead only as part of an actual vaccine formulation, meaning that pure adjuvant companies are totally reliant on a vaccine manufacturing partner to drive the development of a vaccine based on their adjuvant. For the most part, vaccine manufacturers have not been prepared to take on the risk of driving the development of another company's proprietary adjuvant. Hence the only breakthroughs in terms of adjuvant licensing have come from internal adjuvant development programs within large vaccine manufacturing companies, most notably MF59 adjuvant development within Novartis and the AS02 and AS04 adjuvants within GSK. When Vaxine succeeds in getting a vaccine based on its Advax adjuvant platform to licensure, it will represent a unique example of a successful adjuvant being brought to market by a small adjuvant focused biotechnology company. The Advax adjuvant platform offers significant benefits, not only being more effective than existing adjuvants such as alum, but also being safer and better tolerated. The platform has been extensively validated in animal models of biodefense vaccines including for anthrax, pandemic influenza, SARS, Ebola, Marburg, Japanese Encephalitis, West Nile virus, Murray Valley Encephalitis, African hose sickness, glanders, ricin toxin poisoning thereby demonstrating that the Advax™ platform is broadly applicable to development of almost any biodefense vaccine. It has similarly shown promise in vaccines of broad public health relevance, including vaccines against seasonal influenza, herpes simplex, HIV, malaria, shigella, hepatitis B and TB. Advax™ adjuvant has excellent temperature stability, thereby avoiding the need for a cold chain and making it highly amenable to pandemic stockpiling. It doesn't require complex formulation with vaccine antigen simply being mixed and injected with the relevant antigen. Advax is also the only adjuvant shown to be highly effective for single-dose vaccine protection in neonatal models, a major selling point along with its exceptional tolerability.
What were the “highlights” in your recent product development?
Vaxine, over the last 8 y has successfully executed more than 10 vaccine trials involving its Advax™ adjuvant technology. These have included multiple different seasonal and pandemic influenza vaccines as well as vaccines against hepatitis B and insect sting allergy. In total, these trials have enrolled over 2 thousand participants providing a large safety database supporting the Advax™ adjuvant technology. Apart from the achievement in being one of the few biotechnology companies to successfully bring a novel adjuvant to the clinic, Vaxine's single biggest success was in 2009 when in partnership with US-based Protein Sciences, it helped develop the first vaccine against the new swine flu strain, based on the Advax™ adjuvant technology with subsequent success of this vaccine in human clinical trials. Flowing from this achievement, Vaxine went on to win a string of awards including the AMP National Innovation Award at the 2009 Telstra Business Awards, AusIndustry Innovation Award at the 2010 Australian Anthill Cool Company Awards, a Emerging Company of the Year Award at 2011 BioSpectrum Asia Pacific Awards and a Vaccine Industry Excellence Award in 2011 for Most Innovative Asian Biotech. In addition, Prof. Petrovsky as Chairman and Research Director of Vaccine won a Ernst & Young Entrepreneur of the Year Award in 2010 and Asian Executive of the Year Award from BioPharma Asia in 2013. Vaxine is excited by its recent successes in applying in silico methods to vaccine structural modeling and engineering. For example, as part of its current NIH Adjuvant contract Vaxine scientists have been successfully applying this approach to undertake in silico high throughput screening for novel immune ligands. This strong capability in bioinformatics is also being applied to a broad range of vaccine challenges including use of viral sequences to design novel nanovaccine constructs through to development of models to predict evolution of viruses such as influenza, to assist in development of universal influenza vaccines.
What have been the most critical problems in developing products in your field, and how can your company's technology help overcome these problems?
The critical challenge in the adjuvant field has been how to develop an effective adjuvant that is nonetheless safe and non-reactogenic. Advax presents the first real solution to this problem in 100 y of adjuvant research, attesting to its unique properties. Where Advax differs from all other adjuvants is in the unique way it is able to enhance adaptive immune memory in the absence of inflammation, something that no other adjuvant is able to achieve. Indeed, despite its lack of reactogenicity, the Advax platform is extremely potent and not only enhances humoral immunity but also drives strong CD4 and CD8 T cell responses, thereby helping explain the robust protection seen when it is included in vaccines against notoriously difficult pathogens such as HIV and tuberculosis.
What is your company's value proposition?
Vaxine has more than 15 y of experience in nonclinical and clinical vaccine adjuvant development across an exceptional array of pathogen targets. The company has developed a suite of adjuvants and vaccine delivery approaches that have been optimised for human use. Vaxine's adjuvants uniquely combine efficacy with exceptional tolerability and work across the complete spectrum of antigens including inactivated viruses, toxoids, recombinant proteins, polysaccharide conjugates and even live vector vaccines. They also work at the extremes of age and in immuno-compromised individuals such as those with kidney disease or on immuno-suppressive therapy. Lastly, they even work for noninfectious disease vaccines such as vaccines against Alzheimer disease. Hence this is a “go anywhere, do anything,” vaccine adjuvant platform easily adaptable to any potential partner's vaccine strategy.
What business development strategy do you pursue?
Vaxine typically partners with academic groups or small biotechs in the early stage of developing vaccine candidates. The reason for this is that it is extremely hard to introduce a new adjuvant once a vaccine has already reached late stage pre-clinical development, given the additional costs to repeat GLP safety and toxicology studies and the consequent delays it puts on the vaccine's development. Vaxine works closely with these partners to help them with immunological characterization of their vaccine and optimisiation of immunogenicity through inclusion of appropriate adjuvants as well as tailoring the delivery approach. In this way, Vaxine can provide much more value to its partners than our competitors' approach of offering them a one-size-fits-all adjuvant solution.
How does your company attract partners?
Many academic partners are referred to Vaxine by their NIH Program Officers with other referrals coming from existing partners or networking at international vaccine conferences. If Vaxine perceives that there is a need in a particular vaccine field, it will directly approach vaccine developers in that space to see if they are interested to collaborate and test Vaxine's adjuvants in their vaccine candidates.
Who are your most important partners?
Vaxine's most important partners are its academic and biotech vaccine collaborators. Equally important are its funding partners including AusIndustry and the National Institutes of Health. In addition, Vaxine has been successful in bringing its vaccine candidates to the clinic through the great support of the clinicians involved in the various clinical trials.
How do you balance performing work in-house vs out-sourcing?
As a small and dynamic team, Vaxine recognizes it cannot do everything internally and hence the importance of outsourcing for activities where internal capability or resources are limited. Typically we do most vaccine development including immunogenicty studies and clinical trials in house while outsourcing GLP preclinical vaccine safety studies and GMP manufacturing. Given the complexity of vaccine development, when outsourcing it is critical that there is a close working relationship and high quality of communication between the parties to ensure that quality expectations and delivery timelines are met.
What are your product development goals for the next 3 years?
Over the next 3 years, Vaxine expects to take another five or more vaccines from its pipeline into human clinical trials, which will translate into a period of extraordinary activity and excitement as vaccine trial results come to hand. We also expect to take one or more new adjuvants including a mucosal adjuvant into human trials, thereby expanding our human adjuvant portfolio. We also expect to have in place several veterinary licensing deals for the Advax platform. We expect to see our internal antigen-discovery platforms start to bear fruit during this time, allowing us to develop our own wholly internally-developed vaccines against candidates including shigella, influenza and Ebola.
For more information: www.vaxine.net