? Acquisition vaults Virax into a leading multi-product, clinical stage ASX listed biotech
? AKT is a signaling pathway that can lead to cancer – high levels of AKT in cancer patients are associated with poor prognoses and resistance to chemotherapy
? The drug TCN-P blocks the AKT pathway and is currently in Phase 1b/2 breast and Phase 1b ovarian cancer trials with a Phase 1b leukemia trial commencing in early 2015
? Both breast and ovarian trials are funded by US government grants
? Commercial risks minimised with GMP drug manufactured, IND active and clinical trial sites actively recruiting and dosing patients
? TCN-P to be pursued simultaneously with Virax’s other recently acquired drug GGTI- 2418 – meaning the potential for 5 clinical trials under two separate IND applications in the next 12 months
? Shareholders to vote on acquisition at the earliest possible meeting of shareholders
17 October 2014, Melbourne, Australia: Australian biotechnology company Virax Holdings Limited (ASX: VHL) will acquire oncology company AKTivate Therapeutics and its novel TCN-P cancer drug pending shareholder approval.
AKTivate’s technology inhibits the highly promising drug target AKT and includes two active clinical trials – a Phase 1b/2 in breast cancer and an active Phase 1b in ovarian cancer. These trials are fully funded by US government authorities including grants from the Department of defense and National Cancer Institute.
Fifteen patients have been recruited to date for the Phase 1b/2 breast cancer trial at the Montefiore Medical Center in New York, with an enrolment target of 36 patients.
A Phase 1b ovarian cancer trial has also commenced at the prestigious Moffitt Cancer Center in Florida. A further Phase 1 study on patients with Acute Myeloid Leukaemia will begin in 2015.
When completed in late November, the transaction will be Virax’s second major oncology acquisition this year strengthening the company’s product pipeline with two novel and exciting cancer compounds in mid-stage clinical development.
Acquisition terms are weighted towards clinical success and therefore shareholder returns.
Under the terms of the AKTivate agreement Virax will pay a US$300,000 cash consideration as well as 234 million shares at $0.01 per share. 134 million shares will be paid up front, with a further 100 million to be paid on reaching clearly defined clinical success milestones.
Virax Managing Director Dr Robert Crombie said “TCN-P is a highly promising asset presenting an outstanding clinical and commercial opportunity with robust IP, GMP manufacturing complete with ample drug supply and prestigious US cancer centres already dosing patients.”
“Assuming shareholders approve this acquisition on 28 November, we plan to pursue the TCN-P program as a lead priority in tandem with our other complementary oncology compound GGTI-2418.”
“This acquisition has the potential to catapult up-side for Virax shareholders. It also means that in the next 12 months we expect to be driving five clinical trials, under two separate IND applications with two of the most advanced trials funded by US government authorities.“
TCN-P or triciribine phosphate monohydrate is a small molecule that blocks the AKT growth promoting pathway that leads to cancer. AKT is the most frequently mutated pathway in cancer and thus plays a key role in many cancers including those being currently pursued (breast, ovarian and leukaemia) as well as a potential treatment for other cancers in the future.
High AKT expression is associated with a poor outlook, resistance to chemotherapy and shortened patient survival time. In animal studies TCN-P has been shown to strongly suppress the growth of high AKT expressing tumours and to overcome resistance to commonly used chemotherapeutic drugs, a key feature of the TCN-P drug.
Already more than 100 patients have been dosed with TCN-P in extensive trials carried out at highly regarded US cancer centres including the Lee Moffitt Cancer Center in Florida, MD Anderson in Texas and the Memorial Sloan Kettering Cancer Center in New York.
Data from a completed Phase 1 study of TCN-P in hematologic cancers (primarily Acute Myeloid Leukemia or AML) carried out at MD Anderson and Lee Moffitt Cancer Centers has shown encouraging anti-tumour activity. A further Phase 1b study will be undertaken at the Moffitt Cancer Center early in 2015 to maximise traction in the treatment of AML, an aggressive form of cancer that is expected to become more prevalent with aging populations.
Shareholders will be asked to vote on the acquisition at the earliest possible meeting of shareholders.
For further information contact:
Mr Rudi Michelson
Monsoon Communications
Ph: +61 (0) 3 9620 3333
Dr Robert Crombie
Managing Director
Ph: +61 (0) 439 361 331
About Virax
Virax is a clinical stage oncology company currently engaged in the development of novel products for the treatment of cancer. It holds an exclusive worldwide license to the novel cancer compound GGTI-2418 for the treatment of multiple myeloma, breast and pancreatic cancer.
GGTI-2418 is expected to enter Phase 1b/2 clinical trials in breast cancer and multiple myeloma in early 2015.
In addition, the company has granted a license to major French biotechnology company Transgene for access to its 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 oropharyngeal (head and neck) cancer and TG4010 – a treatment for non-small cell lung cancer (NSCLC).
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