Drug response prediction in high-risk multiple myeloma - prediction of melphalan and bortezomib response.


Company News

Hoersholm, Denmark - December 15,  2017 -Medical Prognosis Institute (MPI.ST) ("Medical Prognosis Institute" or "MPI") and Oncology Venture Sweden AB:s (OV:ST) ("Oncology Venture" or "OV") announces a publication under the title "Drug response prediction in high-risk multiple myeloma" is to be published in the scientific magazine "Gene" - the printed version is expected to be available in January 2018. The research behind the publication was done in collaboration between MPI/OV and the Department of Hematology and the Granulocyte Research Laboratory and Department of Clinical Genetics at the Copenhagen University Hospital, Denmark and the Hematology-Oncology department at the Mount Sinai Hospital, NY, USA. In the publication it is demonstrated that the MPI's Drug Response Predictor - DRP® - can predict sensitivity to melphalan (PFS prolonged) and bortezomib (PFS prolonged and better RR). The conclusion is: "This method (i.e. the DRP) may provide us with a tool for identifying candidates for effective personalized medicine and spare potential non-responders from suffering toxicity."

Published mRNA data from 914 patients tissue from four different studies of multiple myeloma was used to test whether the DRP score could predict drug sensitivity, progression free survival (PFS) and drug response in high-risk myeloma.

"This method may provide us with a tool for effective personalized medicine for myeloma and in particular patients with high-risk myeloma who have an unmet need for new treatment strategies," Said Associate professor Annette Juul Vangsted, Senior Consultant, DMSc, Copenhagen University Hospital, Rigshospitalet, Department of Hematology

"We are happy with this research result which further substantiates the usefulness of our proprietary Drug Response Prediction Technology. The products melphalan and bortezomib are important drugs in the treatment of multiple myeloma. Although the products are not within the OV/MPI pipeline it is adding to the concept of creating Personal Response Prediction tools which can be weighty decision tool support to the clinicians and patients" comments CEO, MD Peter Buhl Jensen

About Multiple Myeloma
Multiple Myeloma) is a systemic malignancy in the bone marrow, affecting plasma cells, a important cell of the immune system. The introduction of high-dose therapy with autologous hematopoietic 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(TM), APO010 will be developed for use in treatment of Multiple Myeloma.

About the DRP
Oncology Venture uses the Medical Prognosis Institute (MPI) multi gene DRP® technology to select those patients that, by the genetic signature in their cancer, is found to have a high likelihood of response to a given drug. The goal is to develop the drug for the right patients by screening patients before treatment, whereby the response rate can be significantly increased.  The 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 based on messenger RNA from the patients' biopsies. The DRP® platform (i.e. the DRP® and the PRP(TM) biomarkers) can be used in all cancer types, and is patented for more than 70 anti-cancer drugs in the US. The PRP(TM) is commercialized by MPI for Personalized Medicine. The DRP® is commercialized by Oncology Venture for drug development.

About MPI's Drug Response Predictor - DRP®
MPI's DRP® 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® has been tested in 37 trials, where 29 trials showed that drug-specific DRP® Biomarkers could predict which patients responded well to the treatment. The DRP® platform has amongst others been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP® 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® 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. The DRP® is a Big Data tool based on messenger RNA.
The DRP® platform can be used in all cancer types, and has been patented for more than 60 anti-cancer drugs in the US.

About MPI
Medical Prognosis is a publicly traded international company specialized in improving cancer patients lives by developing Personalized Medicine using its unique DRP® 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® 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 1,100 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.

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 an exclusive license to use the Drug Response Predictor (DRP®) technology 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' tumors' genes are screened first with DRP® 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 in collaboration with Cadila Pharmaceuticals, Irofulven developed from a fungus for prostate cancer and APO010 - an immuno-oncology product for Multiple Myeloma. Oncology Venture has spun out two companies in Special Purpose Vehicles: 2X Oncology Inc. a US based company focusing on Precision medicine for women's cancers with a pipeline of three promising phase 2 product candidates and Danish OV-SPV 2 will test and potentially develop the Novartis small molecule kinase inhibitor.

For further information, please contact:
CEO, Peter Buhl Jensen, MD, PhD                                                           Ulla Hald Buhl, IR & Communication
E-mail: pbj@medical-prognosis.com                                                          E-mail: uhb@medical-prognosis.com
Telephone: +45 21 60 89 22                                                                                        Telephone +45 21 70 10 49