Cisplatin and APO010 abstracts selected by ESMO’s Scientific Committee for poster presentation on its annual congress

Hoersholm, Denmark; August 8th, 2016 – Oncology Venture Sweden AB (OV:ST) announces that 2 abstracts have been selected by the Scientific Committee for Poster Presentations at the Annual Congress of European Society of Medical Oncology - ESMO - held on October 7 - 11 2016 in Copenhagen, Denmark.

One presents Drug Response Prediction (DRP™) data from Oncology Ventures immuno-oncology product APO010 for Multiple Myeloma and the other presents data from Drug Response Prediction on cisplatin for Lung Cancer (the same DRP is used in the OV LiPlaCis drug for Breast Cancer).

ESMO is expected to be attended by around 20.000 professionals, scientists, doctors, patients, and students from all over the world.

ESMO is the leading European professional organisation for medical oncology. Comprising more than 13,000 oncology professionals from over 130 countries. ESMO is the society of reference for oncology education and information.

“Combining APO010 with DRP analysis will add a precision medicine element to immuno-oncology treatment of Multiple Myeloma. The DRP method will enable us to identify patients with high likelihood of response and thereby facilitate focused future trial design and patient recruitment to achieve clinical success. I look very much forward to the presentation of the prediction method at the largest oncology congress in Europe,” Said Adjunct Professor Peter Buhl Jensen, M.D., CEO of Oncology Venture.

“Cisplatin is one of the most used chemotherapies in the world and there is a need for biomarkers to predict efficacy of the drug. Oncology Venture is running a Proof of Concept clinical trial with LiPlaCis, a liposomal formulation of cisplatin, in breast cancer and I expect the data to be presented for the DRP in lung cancer at this years’ ESMO is supportive for the Breast Cancer study as well.” Buhl Jensen further commented.

Further conference details will be announced once this has been communicated to Oncology Venture.

About APO010

APO010 is a multimeric form of FAS-ligand for immuno-cancer therapy with a unique mechanism of action. APO010 acts through the FAS-receptor leading to apoptosis of the malignant cells. APO010 is expected to act in synergy with other cancer immunology agents such as ipilimumab and PD-1/PD-L1 inhibitors. The drug candidate is complemented by a companion diagnostic technology (APO010 DRP™) for enrichment of the patient population. APO010 was tested in 25 patients with solid tumors in a phase 1 study. The drug was well tolerated. Pre-clinical studies have revealed that APO010 is highly efficient in Multiple Myeloma. Therefore, a clinical proof of concept phase trial will be conducted in patients with Multiple Myeloma that have been pre-screened for sensitivity using the APO010 DRP™ technology.

There is a great need for effective treatment against Multiple Myeloma, and the market value was over 7 billion USD during 2014. Researchers estimate the value of the cancer immunotherapy market to 35 billion USD by 2023 (Citi GPS).

About Multiple Myeloma

Multiple Myeloma (bone marrow cancer) 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.

About LiPlaCis

Cisplatin is one of the most widely used drugs in the treatment of cancer due to its documented efficacy in a number of tumour types. Cisplatin is used in the treatment of large indications as lung cancer EU+US ≈ 480,000 new cases annually), head and neck cancer (500,000 cases annually worldwide) bladder cancer (EU+US ≈ 170,000 annually) and ovarian cancer (EU+US ≈ 71,000 annually). The lipid formulation in LiPlaCis is the answer to a well-established need for improving cisplatin therapy and improving the formulation of the drug, so that a more selective up-take of cisplatin administered takes place at the tumour sites. A mechanism called was incorporated into the liposomes designed to trigger the release of an encapsulated drug specifically in the tumour tissue. An enzyme especially present on tumors called secretory phospholipase A2 (sPLA2), is utilised to break down the LiPlaCis once it has accumulated in the cancer tissue. The lipid composition is tailored to be specifically sensitive to degradation by the sPLA2 enzyme and thereby for release of the encapsulated drug.

About the Drug Response Predictor -DRP™ - screening tool

Oncology Venture uses the MPI DRP™ to select those patients that by the gene signature in their cancer is found to have a high likelihood of response to the drug. The goal is to develop the drug for the right patients and by screening patients before treatment the response rate can be significantly increased.

This DRP™ method builds on the comparison of sensitive vs. resistant human cancer cell lines including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. The DRP™ is a Big Data tool based on messenger RNA.

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About Oncology Venture Sweden AB

Oncology Venture Sweden AB is a clinical stage, drug development company 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 clinical product portfolio: LiPlaCis for Breast Cancer, Irofulven for Prostate Cancer and APO010 – an immuno- oncology product for Multiple Myeloma.