18 Mar 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Biolife Science has signed a letter of intent with Swiss company Pevion Biotech for the manufacture of Biolife's HER-Vaxx vaccine and exclusive licensing access to intellectual property and formulation know-how. Pevion will manufacture a peptide chain that is stable and can be administered in a single dose. The manufacturing cost for clinical trial supplies is estimated at approximately $1 million and due to take approx nine months to develop.
Pevion specializes in vaccines for unmet medical needs, having developed a proprietary virosome technology that can act as both a carrier and adjuvant. This technology is proven and licensed to Johnson & Johnson. Two successful virosome-based vaccines manufactured by Pevion are Crucell Switzerland's Epaxal and InflexalV which are licensed in over 40 countries and have a combined 70 million plus doses commercially distributed.
"Pevion has a wealth of experience in the manufacture of sophisticated products such as HER-Vaxx and enjoys an enviable safety and efficacy record," said Dr Roger Aston, executive chairman, Biolife Science. "We look forward to adding HER-Vaxx to its growing list of commercially and clinically proven products for distribution."
Biolife's HER-Vaxx vaccine has shown significant success in stimulating the production of lifesaving HER-2 antibodies in late-stage cancer patients. It is expected to provide a natural, potentially more potent alternative to the blockbuster injectable antibody, Herceptin, which has become one of the world's best-selling cancer drugs with sales of $6.4 billion in 2012.
Metastatic breast cancer patients in Biolife's phase I vaccine study developed HER-2 antibodies that bind to the Herceptin target, thus potentially inducing an antibody response with similar properties to Roche's Herceptin and effectively turning the patient's body into a "Herceptin factory". An Investigational New Drug (IND) application for HER-Vaxx is expected to be filed with the FDA in Q3 2013. Biolife is seeking to raise $5 million and list on the ASX using the company shell of Acuvax. Furthermore, after Acuvax undergoes a 200-to-one share consolidation, a placement of up to 25 million shares at $0.20 each will give Biolife an initial market cap of $11.3 million and pave the way for the phase II trials of HER-Vaxx.