Press release issued by Oncology Venture Sweden AB Hoersholm, Denmark, 30 September 2015 Press release OV has incorporated its APO010 DRP™ in its clinical program Oncology Venture announces that it has incorporated the APO010 Drug Response Predictor – (APO010 DRP™) from MPI A/S into its clinical development program. Based on the DRP it has been decided to develop APO010 into the treatment of multiple myeloma. The DRP™ will consequently be used in the screening of Multiple Myeloma patients in a phase 1b/2 program, which is planned to be initiated in Q4 2015 as a multi-center study at hematology departments in Denmark. The purpose of the screening is to find the screening is to select the patients with the highest likelihood to respond to APO010. “It is the hope that the DRP™ technology will increase the probability of providing an effective drug to the individual patient. In this study we aim to select those multiple myeloma patients who by the look of their personal gene signature have the highest likelihood of response to our anticancer drug APO010. At the same time the objective is to prove APO010 as an effective drug for treatment of multiple myeloma when existing drugs have failed. ” said CEO, MD, PhD, Adjunct Professor of Clinical Oncology Peter Buhl Jensen. About in-licensing of the APO010 DRP™ The DRP evaluation runs in two successive decisions. On step one MPI examines whether a DRP™ can be developed to the specific drug in question – and OV obtains initial rights. On second step OV has completed its analysis of the market potential and the possibility of positioning the drug to meet important medical needs in cancer treatments. A second fee is then payed to MPI for global rights to a fully developed DRP™. About APO010 APO010’s potential value as a tool in immune therapy is strengthen by new data. A series of recent dramatic advances has demonstrated that the human immune system can kill cancer cells and can be an important player in the fight against cancer. The human immune system can kill cancer cells by use of a certain type of white blood cells called cytotoxic T lymphocytes CTLs. One of the way CTLs kill cancer cells in a process called programmed cell death (apoptosis). By binding to a death receptor on the cancer cell a series of processes destructs the cancer cell. The CTLs bind to the cancer cell via a ligand called Fas ligand or Fas-L to a receptor (CD95) on the tumor cell. APO010 is synthesized as a mega FasL consisting of six FasL and the cancer cell sees this as if it was a cell, a CTL that binds to the cancer and the cancer cell can undergo apoptosis. The presence of the death receptor is however not enough to ensure cancer cell death. Whether the cancer cell is killed or not is more complex and this is where Oncology Ventures technology is important. By use of MPI’s DRP™ Oncology Venture can predict which patients will be most likely to respond to APO010 treatment. APO010 has in pre-clinical studies demonstrated that it is effective in killing cancer cells also when they have become resisting to other drugs. APO010 has been in phase 1 and is now ready to enter a focused trial in multiple myeloma. About Multiple Myeloma (MM) The study is a phase 1b, open label, dose escalation study to investigate the tolerability and efficacy of APO010 in patients with relapsed/refractory multiple myeloma selected by drug sensitivity prediction score from gene expression microarray analysis. The phase 1b study will start with the screening of MM patients tumors to identify those who are most likely to respond to APO010. Multiple myeloma is a hematologic systemic malignancy. The introduction of high-dose therapy with autologous stem cell support and subsequent introduction of new therapies like the proteasome inhibitor bortezomib (Velcade) and IMIDs (thalidomide and lenalidomide (Revlimid)) has improved the outcome with increasing response rates and prolonged progression free and overall survival. The multiple myeloma treatment market value in 2014 was 7.3 billion to a large degree because of these new options but in spite of these improvements many patients eventually will experience progressive disease and continue into second and later lines of treatment. APO010 was selected as it has full activity multiple myeloma cells with resistance to other therapies. The efficacy of the treatment of relapse/refractory myeloma is reduced with the number of treatment lines. For further information concerning Oncology Venture please contact: Peter Buhl Jensen, CEO Telephone: +45 21 60 89 22 E-mail: [email protected] Press release issued by Oncology Venture Sweden AB Hoersholm, Denmark, 30 September 2015 Press release About Oncology Venture Sweden AB Oncology Venture Sweden AB is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has a license to use Drug Response Prediction – DRP™ – in order to significantly increase the probability of success in clinical trials. The business enterprise is based on “rescuing” anti-cancer drugs whose development has been interrupted in the clinical development stage. DRP™ has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 26 of the 32 clinical studies that were examined. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients are screened first and only those who are most likely to respond to the treatment will be treated. Via a more well-defined patient group, the risk and costs are reduced while the development process becomes more efficient.
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