Hoersholm, Denmark, June 8th, 2017 - MPIs spinout Oncology Venture Sweden AB ("OV") today announced that 2X Oncology, Inc. - ("2X") (Cambridge, MA), a daughter company of OV a precision medicine company developing targeted therapeutics to address significant unmet needs in women's cancer, has obtained the Investigational New Drug (IND - i.e. allowance to run clinical trials in the US) application for 2X-111 (doxorubicin hydrochloride and glutathione) from 2-BBB Medicines B.V. wherefrom the drug has been in-licensed:2X-111 is being developed as a new treatment option for women with brain metastases from breast cancer and for patients with recurrent glioblastoma multiforme (GBM). 2X-111 will be developed in two focused Phase 2 trials in metastatic Breast Cancer and in Glioblastoma an orphan-designated condition in 2X Oncology Inc. Data from these studies are expected in 2018 which, if positive, can position this program for possible accelerated approval filings. 2X is currently owned 92% by Oncology Venture and when a series A round has been finalized MPI will own 10% of 2X Oncology.
"It is of great value for the 2X-111 project to have the IND in place in the US for the running of clinical trials", said Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. "The Breast cancer trial will in accordance with our plans initially be run in already screened breast cancer patients at Danish sites; The study in Glioblastoma (Cancer in the Brain) is planned to be initiated at Danish sites followed by US site(s) for which we have now obtained an IND",. "Having this IND in place is an important step as we focus on initiating Phase 2 clinical trials of 2X-111 in GBM and brain metastases from breast cancer later this year." Peter Buhl Jensen further commented.
Formerly known as 2B3-101, 2X-111 improves on commercially available PEGylated liposomal doxorubicin products with an additional glutathione coating that safely enhances drug delivery across the blood-brain barrier. Doxorubicin is an anthracycline that inhibits the growth of many cancerous cell lines, including glioblastoma and breast cancer cell lines. It is among the most widely used anti-cancer agents.
An abstract on the predictive ability of the DRP in treating advanced breast cancer with a similar anthracycline, epirubicin, was presented in a poster-session at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. The abstract describes a retrospective-prospective blinded study which evaluated the ability of the DRP to predict the efficacy of epirubicin in a cohort of 135 metastatic breast cancer patients. The DRP was significantly associated with progression free survival in this study. The estimated median time to progression for a patient with a DRP value of 25% was 7 months, versus 13 months for a patient with a DRP value of 75%.
Mr. Elston will discuss 2X-111 and other 2X pipeline drugs at the Jefferies 2017 Global Healthcare Conference on June 9, 2017, at 10:00am EDT. The presentation will be available as a and the link will be distributed in an Investor Information press release and posted on the companies' websites once available.
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 60 anti-cancer drugs in the US.
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 1,100 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.
For further information, please contact
| Peter Buhl Jensen, VD |
Telephone: +45 21 60 89 22
| Ulla Hald Buhl, Chief Investor Relations and Communications |
Telephone: +45 21 70 10 49