APO010 screening protocol approved

Hoersholm, Denmark; March 3rd, 2016 – Oncology Venture Sweden AB (OV:ST) today announced that the screening protocol for APO010 in Multiple Myeloma (MM) has been approved by the Ethics Committee. APO010 is a first in class FASLigand anticancer product in the immuno-oncology field.

OV will now initiate the screening of approximately 150 patients at 4 sites at Danish hematology wards and identify 15 patients with the highest likelihood of APO010-benefit in a focused phase 2 multi center study. The Drug Response Predictor (DRP™) uses genomic information from the individual cancer patient’s tumor. If the product already on shelf is approved, Phase 2 is expected to start Q2-Q3 2016.

“I look very much forward to initiate the screening of Multiple Myeloma (MM) patients for eligibility for the proof-of-concept phase 2 trial with APO010. This new immuno- oncology product mimics our immune system and is a first in class product which we believe can become a new treatment option in Multiple Myeloma,Said Adjunct professor Peter Buhl Jensen, M.D., CEO of Oncology Venture.

APO010 is a FAS-ligand drug that only works when the FAS-receptor is present. To increase response odds OV uses its DRP™ to find the patients who in the genes of their tumor has a signature that matches with APO010 and therefore are high likelihood responders. OV will screen the patients and include only those with the highest likelihood of response in its phase 2 clinical trial.

About Multiple Myeloma

Multiple myeloma (MM) is a systemic malignancy in the blood affecting plasma cells. The introduction of high-dose therapy with autologous stem cell support and introduction of new therapies like the proteasome inhibitor bortezomib and IMIDs (thalidomide and lenalidomide) has improved the outcome. In spite of this eventually all patients will experience progressive disease and continue into second and later lines of treatment. OV will approach this important clinical issue by introducing a novel systemic chemotherapeutic treatment together with a predictive biomarker test.

Based on DRP, APO010 will be developed for use in treatment of Multiple Myeloma (blood cancer) a market with a turnover of seven billion USD in 2014.

About APO010

APO010 employing on immune oncology cell signaling strategy to kill cancer cells. APO010 is a novel chemotherapeutic agent that mimics cytotoxic T-lymphocyte signaling. The mechanism of action of APO010 is the specific induction of cell death in Fas-expressing cells through binding to the Fas receptor and activation of well-characterised Fas-mediated death-receptor pro-apoptotic pathway. A phase I study has previously been conducted including 26 patients. In this study the patients were not selected based on likelihood of benefit from APO010.

About the Drug Response Predictor (DRP™) screening tool

This method builds on the comparison of sensitive and resistant human cancer cell lines including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network.

For further information, please contact

Peter Buhl Jensen, CEO

Telephone: +45 21 60 89 22

E-mail: pbj@oncologyventure.com

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. DRP™ has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 29 of the 37 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.

The current product portfolio: LiPlaCis™ for Breast Cancer, Irofulven developed from a fungus for prostate cancer and APO010 – an immuno- oncology product for Multiple Myeloma.


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