Hoersholm, Denmark, April 9, 2018 - Medical Prognosis Institute A/S (MPI:ST) ("MPI" or the "Company") today announced that Oncology Venture has entered into an agreement with Novartis Pharma AG (Basel, Switzerland) for the exclusive global rights to develop and commercialize dovitinib (TKI258), a small molecule, multi- tyrosine kinase inhibitor (TKI). Novartis will receive an upfront payment, development milestones, and royalties on sales. Today's announcement follows on an earlier agreement between the companies, that included an option for OV to in-license dovitinib at predetermined conditions. As part of the agreement, Novartis will be issued a convertible debt-to-equity note in a spinout company that OV has created to advance clinical development of the drug. Further terms of the agreement were not disclosed.
In a Phase 3 trial in metastatic renal cell carcinoma, dovitinib achieved therapeutic equivalence with the current standard of care, sorafenib. Earlier stage studies explored its potential utility in multiple therapeutic indications including liver cancer, breast cancer and various solid tumors. OV intends to advance the compound in clinical trials together with a validated, drug-specific DRP® biomarker developed by MPI as a companion diagnostic.
"Dovitinib has demonstrated clinically relevant efficacy in renal cancer and breast cancer and good efficacy in several other solid tumors, and we are excited to accelerate the development of the compound. We are confident that, by using our Drug Response Predictor (DRP®) biomarker for dovitinib to select likely responder patients - and the recent success with a combination of a TKI and a PD-1 inhibitor (Keytruda®) in renal cancer - we will raise the chances of success for dovitinib in further clinical development. The Dovitinib DRP® biomarker could then be consequentially filed together with the Marketing Authorisation Application and used as a predictive companion diagnostic to select likely responders," said Peter Buhl Jensen, M.D., CEO of Medical Prognosis Institute.
During the prior option period, OV validated its proprietary DRP® biomarker for the compound against anonymized biopsy data from the Novartis Phase 3 renal cancer study. A consistent signal was seen indicative of this biomarker's ability to predict clinical benefit of dovitinib.
Under the global license agreement, OV will further refine the Dovitinib DRP® biomarker to hone its predictive ability by analyzing data from additional biopsies and genomic data sets from other previous, relevant clinical studies with this promising compound. Dovitinib DRP® will then be used to prospectively select patients most likely to respond to the compound for inclusion in a planned Phase 2 trial of the drug for the treatment of breast and liver cancer.
Oncology Venture recently announced positive interim results from another DRP®-guided oncology program. In a prospective Phase 1/2 study of LiPlaCis® (a targeted liposomal formulation of cisplatin) in heavily pre-treated breast cancer patients, in which enrollment was guided by the LiPlaCis DRP® biomarker, clinical benefit was shown in 7 out of 10 evaluable patients. By comparison, conventional cisplatin treatment of metastatic breast cancer has reported a response rate of only 10 percent in previously conducted trials. This suggests that the LiPlaCis DRP® successfully identified likely responders for inclusion into the clinical trial.
For further information, please contact:
CEO, Peter Buhl Jensen, MD, Ph.d. Ulla Hald Buhl, IR & Communications
E-mail: pbj@medical-prognosis.com E-mail: uhb@medical-prognosis.com
Telephone: +45 21 60 89 22 Telephone +45 21 70 10 49
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 1,400 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 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 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(TM)) 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 which will test and potentially develop the Novartis small molecule kinase inhibitor. Oncology Venture currently owns 92% of 2X Oncology Inc. and 40% of OV-SPV2 ApS.
This information is information that Medical Prognosis Institute A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on April 9, 2018.
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