First patient included in APO010 immuno-oncology screening trial by MPI's spinout Oncology Venture

2016-03-10

Hoersholm; March 10th, 2016 - Medical Prognosis Institute A/S (MPI.CO) (Denmark and Phoenix, AZ, USA) today announced that the first patient has been included in the APO010 Screening Protocol for Multiple Myeloma by MPI's spinout OV. This patient has entered the study at the first out of four planned participating Danish hematology sites. Approximately 150 patients will be screened using MPI's DRP(TM) (Drug Response Predictor), out-licensed to Oncology Venture. The DRP(TM) uses genomic information from the individual cancer patient's tumor. The screening will identify 15 patients with the highest likelihood to benefit from treatment with APO010. These 15 Multiple Myeloma patients will then be included in a focused phase 2 multi-center study. The phase 2 study is expected to start Q2-Q3 2016, if the product already in stock is approved. APO010 is a first-in-class FAS-ligand anticancer product in the immuno-oncology field.

I 'm very happy that the first patient has been included in the screening for APO010 sensitivity in Multiple Myeloma patients. Fifteen of the highest likely sensitive patients will be included in a proof-of-concept phase 2 trial with this first in class immuno oncology product", says Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. MPI has already screened more than 1000 metastatic breast cancer patients and the Multiple Myeloma screening is the next step in building the Personalized Medicine tool." Peter Buhl Jensen further commented.

About MPI's multiple biomarker called Drug Response Predictor - DRP(TM)
MPI's lead product, the DRP(TM) Diagnostic Platform, is a tool for developing tumor-derived genetic signatures to predict which cancer patients are high likely to respond to a given anti-cancer product. The DRP(TM) has been tested in 37 trials, where 29 trials showed that drug-specific DRP(TM) Biomarkers could predict which patients responded well to the treatment. The DRP(TM) platform has amongst others been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP(TM) method can be used to design the Clinical Development Plan, i.e. to select which indications are relevant for a given   anti-cancer drug.  In addition to this, the individual genetic patterns of patients can be analyzed as part of a screening procedure for a clinical trial to ensure inclusion of patients with a high likelihood of response to the drug. DRP(TM) builds on comparison between 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. MicroRNA is used on certain products whereas the messengerRNA is more broadly useable and more validated. The DRP(TM) platform can be used in all cancer types, and has been patented for more than 60 anti-cancer drugs in the US.

About Multiple Myeloma
Multiple Myeloma is a systemic malignancy in the blood accumulating plasma cells in the bone marrow. 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 subsequent 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(TM), APO010 will be developed for use in treatment of Multiple Myeloma, a market with a turnover of seven billion USD in 2014.

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 PD1-PD-L1 inhibitors. The drug candidate is complemented by a companion diagnostic technology (APO010 DRP(TM)) 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 phase 2 trial will be conducted in patients with Multiple Myeloma that have been pre-screened for sensitivity using the APO010 DRP(TM) 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 MPI
Medical Prognosis is a publicly traded international company specialized in improving cancer patients lives by developing Personalized Medicine using its unique DRP(TM) technology. MPI's exceptional opportunity to personalize cancer treatment - begins with Breast Cancer moving on to Multiple Myeloma and Prostate Cancer as the first steps. MPI's DRP(TM) tool has shown its ability to separate patients who benefit and who do not benefit from a specific cancer treatment. This has been shown in as many as 29 out of 37 trials, and covers more than 80 anti-cancer treatments in a wide range of cancer indications. MPI has built a significant large database with over 1,000 screened breast cancer patients and is building up a database in Multiple Myeloma to be followed by Prostate cancer in collaboration with oncologists and hematologists throughout Denmark.

For further information, please contact
CEO, Peter Buhl Jensen, Adjunct Professor, MD, Ph.D.
E-mail: pbj@medical-prognosis.com
Phone: +45 21 60 89 22

Certified Advisor: Carsten Yde Hemme, PricewaterhouseCoopers, Strandvejen 44, 2900 Hellerup, Denmark