Virax Co-X-Gene Technology Licence with Transgene Successful Phase IIb trial Result for TG4010 in Non-Small Cell Lung CancerMELBOURNE, Australia, June 3, 2008-Virax Holdings Limited (ASX:VHL) advises that Transgene SA of Strasbourg, France, reported successful Phase IIb data for its therapeutic cancer vaccine TG4010 when used as an adjunct to first line chemotherapy in patients with advanced non-small cell lung cancer.
TG4010 uses Virax’s Co-X-GeneTM technology under the Licence Agreement between the Company and Transgene.
Transgene stated that the trial met its primary endpoint for progression free survival at six months and that the response rate was substantially higher for the combination of TG4010 with chemotherapy compared to chemotherapy alone. Chief Executive Officer of Transgene, Phillipe Archinard, said “These results clearly warrant pursuing development into a Phase III program and we will be seeking to establish a partnership in order to complete the last stages of clinical development and bring TG4010 to the market”.
Virax’s Chief Executive Officer, Larry Ward stated “these positive trial results are further validation of both the Co-X-GeneTM technology and the significant commercial value of the Transgene Licence. It is very exciting that both TG4010 and TG4001, products covered in the Agreement with Transgene, should now soon enter Phase III testing.” The Virax-Transgene Licence Agreement allows Virax to share in fees and milestone payments in the event that
Transgene sub-licences out either of the products and reaches development milestones. In addition Virax will receive a royalty on net sales for the licensed products in North America. Bryan Garnier and Co Ltd (Manager of public offering by Transgene) estimated peak annual sales of €750 million for TG4010 and €250 million for TG4001 in its “Emerging Growth Research Report” dated 6 June 2005.
Under the Transgene Licence, the Company has already received milestone payments for TG4001 and licence fees totalling $2.2m.
Virax, based in Melbourne, Australia, is a biopharmaceutical company engaged in the discovery and development of novel immunotherapeutic products for the treatment of chronic infectious diseases and cancer. The Company’s lead product, VIR201, an HIV/AIDS immunotherapeutic (therapeutic vaccine), has been tested successfully in two clinical trials in Australia with additional international studies planned. Regulatory clearance has been received from the US FDA to perform Phase II testing of VIR201. The Company has also submitted an application to the South African regulatory authority (MCC) to conduct a Phase I/IIa trial of VIR201. Funding for the African trial has been contributed by a consortium of global and South African resource companies led by BHP Billiton. In March 2007 Transgene (Eurolist Paris: FR0005175080) executed a Licence Agreement with the Company for access to Co-X-Gene™ technology for use in two of Transgene’s immunotherapeutic products. These are TG4001 – a treatment for pathologies relating to human papilloma virus (HPV) infection that can lead to cervical cancer - and TG4010 – a treatment for non-small cell lung cancer. This was reported to the ASX in the Company’s announcement of 13 March 2007 and is referred to as the “Transgene Sub-licence”. TG4001 is in advanced development with Phase III trials planned for 2008. Transgene has licensed TG4001 to the pharmaceutical company Roche for treatment of HPV related pathologies.
Additional information about Virax is available at www.virax.com.au
Posted: June 2008