Vaxine wins Start grant and equity partner

There’s a distinct, rosy glow on the commercial horizon for unlisted Canberra vaccine developer Vaxine, with the company winning a AUD$770,000 AusIndustry R&D Start grant to advance its new-generation hepatitis B vaccine, and bringing in an equity partner to boost its cash reserves.

CEO Ted Stapinksi said the Commonwealth grant would enable Vaxine to begin Phase I clinical trials to confirm the safety and tolerability of the vaccine, which is boosted with the company’s proprietary Advax adjuvant. The Asvax Super D adjuvant is a form of the molecule inulin, extracted from dahlia tubers.

The company is “very excited” by pre-clinical trial results indicating the vaccine induces markedly improved antibody and cytotoxic T-cell responses compared to currently available vaccines marketed by companies like GlaxoSmthKline and Merck & Co, Stapinski said.

Hepatitis B is the world’s most common liver infection -- the disease is rife in Asia and Africa. Chronic infection kills around 1 million people a year, by causing cirrhosis or liver cancer. The disease is currently incurable.

Stapinski said the company believes there is a potentially lucrative opportunity for an improved vaccine to prevent hepatitis B. The viral antigens used in current vaccines are coming off patent. Current vaccines do not elicit a protective T-cell response, and diabetics and patients with kidney problems require better protection against the risk of accidental infection by dialysis or insulin injections.

Vaxine has selected an undisclosed antigen for its own vaccine, and used Super D to make it work better -- so much so, that it might even provide some therapeutic benefit to patients with chronic hepatitis B infections, Stapinski said.

While the new vaccine will be trialled only in its prophylactic formulation, if the trial goes well, the company would move rapidly to develop a modified, therapeutic version.

Stapinski said there was another major commercial opportunity in a therapeutic vaccine that could offer hope to millions of chronically infected patients in Asia and Africa at risk from cirrhosis or liver cancer -- but this is a more difficult challenge.

The Vaxine product is free of the aluminium and mercury used as adjuvants or preservatives most current hepatitis vaccines (except for the GSK and Merck vaccines).

The company believes it will be possible to use the vaccine subcutaneously, rather than intramuscularly -- intramuscular administration can cause adverse reactions in some patients.

Rapid push to market

The current global market for hepatitis B vaccines is more than US$2 billion a year, and there is no Australian producer of a vaccine.

Stapinski said the vaccine would allow Australia to become self-sufficient in hepatitis B vaccine production, as well as having the potential to create significant export income.

Vaxine plans to move the new vaccine rapidly into the market, then use revenues to fund development of other products in its pipeline, including vaccines for serious diseases including malaria, diabetes and gastro-intestinal cancer.

Sydney-based commercialisation hub ATP Innovations has become an equity partner in Vaxine, through its wholly-owned investment company, bizCapital, to support the commercialisaton of its novel adjuvant technology. ATPI’s biobusiness director, Paul Field, has been appointed to the Vaxine board.

Stapinski said the company would not attempt to license the vaccine until after Phase II trials, to maximise its commercial return, and may even try to take it right through Phase III and manufacture it itself, to maximise its commercial return. It would then seek a commercial partner or licensee with an established distribution network in Asia.

The company believes this DIY approach is feasible because its out-of-patent antigen has already proven safe in existing vaccines; only the adjuvant is new.

“But hepatitis B is not the main game,” Stapinski said. “It just provides us with a means of getting a relatively rapid return from our current investment, so we can move our unique vaccines into the commercial pipeline.”