Hoersholm, Denmark, May 31st, 2017 - Medical Prognosis Institute A/S (MPI:ST) today announced that the first patient has entered the Oncology Venture APO010 Phase 1/2 study for Multiple Myeloma (MM). APO010 is a first-in-class FAS-ligand anticancer product in immuno-oncology. The DRP(TM) (Drug Response Predictor) Screening for sensitive patients with MM at four centers has been ongoing and >50 patients have already consented to have their tumor tissue DRP analyzed. In total 150 evaluable patients, will be screened using MPI's DRP(TM) with the aim to identify those Multiple Myeloma patients with the highest likelihood to benefit from treatment with APO010.
"I'm excited that APO010 is now in clinical use in Multiple Myeloma. This the second shot on goal to have our DRP technology prospectively validated in a clinical trial. APO010 is in addition to being an immunotherapeutic with checkpoint inhibition properties - a potent killer of tumor cells by itself," says Adjunct Professor Peter Buhl Jensen, M.D., CEO of Oncology Venture.
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(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. Next step is a focused study on 15 patients with Multiple Myeloma that have been pre-screened for sensitivity using the APO010 DRP(TM) technology.
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(TM), APO010 will be developed for use in treatment of Multiple Myeloma.
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.
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
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