Hoersholm, Denmark, March 24th, 2017 - Medical Prognosis Institute A/S (MPI.ST) (Denmark and Phoenix, AZ, USA) today announced that Oncology Venture have entered an agreement with Eisai Inc. (Woodcliff Lake, NJ, USA) under which Oncology Venture will develop a Companion Diagnostic utilizing MPI's Drug Response Predictor, DRP(TM) technology for an undisclosed Eisai oncology therapeutic agent in order to evaluate its interest in in-licensing the drug for further clinical development in the OV spin-out, 2X Oncology Inc. (Boston, MA USA). The agreement does not imply costs for MPI.
If the DRP(TM) evaluation is successful, OV may exclusively in-license the drug for further development within and by 2X Oncology Inc. The drug-specific DRP(TM) biomarker will consequently be used as a predictive companion diagnostic to select and enroll likely responder patients with a women's cancer indication in a clinical Phase 2 trial. The drug is a targeted small molecule inhibitor that has promising application in a number of human cancers.
For further information of collaboration agreement between MPI and OV please refer to press release of December 30th 2016.
"MPI's technology is getting Big Pharma attention. This agreement with Eisai is one of up to seven shots on goal for MPI/OV to evaluate the DRP(TM)s ability to select high likelihood responding patients to cancer products that have already demonstrated excellent clinical effect in cancer patients. If the DRP(TM) is successful the Eisai drug will be in-licensed and developed in 2X Oncology in a focused phase 2 trial.," says Peter Buhl Jensen, M.D., CEO of MPI.
About MPI's multiple biomarker called Drug Response Predictor - DRP(TM)
MPI's DRP(TM) 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. The DRP(TM) is a Big Data tool based on messenger RNA.
The DRP(TM) platform can be used in all cancer types, and has been patented for more than 70 anti-cancer drugs in the US.
More about tumor biopsies
The pathologist evaluates biopsies to see if it is cancer. At the operational theatre, the surgeon places the biopsy in formalin and submits the specimen to the pathology department. Here a technician embeds the tumor biopsy in a paraffin block to allow the cutting of very fine slices of the specimen. The slices are put on glass slides and stained with various dyes and finally evaluated by the pathologist. The tumor in formalin and paraffin are stored. The biopsy block belongs to the patient and follows her or him if she or he changes hospital. In Scandinavia, hospitals are mostly public and patients usually stick to their local hospital. The patient and her or his clinical data can be followed over years as well as CT scans and blood tests. Biopsy blocks can be reclaimed for tests.
In MPIs and Oncology Ventures LiPlaCis study more than 1,100 patients have agreed to allow the two companies to attain material from the paraffin embedded biopsies and to measure the gene expression on the material and relate it to treatment outcome. Gene expression is a measurement of the activity of the genes. Some are very active some are not active. There are 20,000 (twenty thousand) genes in normal tissue and in cancer and modern gene expression technology allows the measurement all the genes in one step on a single chip. MPI uses the commercially available Affymetrix chip for this purpose. MPI has developed and validated a link between gene expression and the efficacy of a range of anticancer drugs. This press release informs about a validation of the method by use of biopsy material and clinical data on four anticancer agents used in daily practice for breast cancer treatment. The companies have worked together with the Danish Cooperative Group for Breast Cancer and breast cancer experts on 10 hospitals to attain the data. The study encompasses data from more than 800 patients with metastatic Breast Cancer receiving almost 2800 treatment lines or an average of 3.5 treatments per patient. Biopsies were from the original diagnosis of Breast Cancer i.e. at a time where the patient was evaluated as curable and most of the patients at then received so-called adjuvant therapy with chemotherapy, irradiation and antihormone therapy after surgery. On average the biopsies were 10 years old.
Medical Prognosis Institute 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.
* Adjuvant systemic therapy in early breast cancer: impact of guideline changes and clinicopathological factors associated with nonadherence at a nation-wide level. A. M. F. Verschoor et al. Published online: 12 August 2016 Springer Science+Business Media New York 2016
For further information, please contact:
CEO, Peter Buhl Jensen, Adjunct Professor, MD, Ph.D. Ulla Hald Buhl, IR & Communication
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