Cancer response to OV's LiPlaCis successfully predicted in early data by MPIs DRP technology

2017-06-27

Hoersholm, Denmark, June 27th , 2017 - Medical Prognosis Institute A/S ("MPI") announces that data from the ongoing LiPlaCis Phase 1/2 study shows that tumor response to LiPlaCis can be predicted by the Drug Response Predictor (DRP(TM)) independent of tumor type and including Breast Cancer. The LiPlaCis DRP has been out-licensed to Oncology Venture - a spinout of MPI dedicated to anticancer drug development utilizing MPI's DRP technology.

Data included in the analysis of 11 patients derives from available tissue from patients - some who responded to the LiPlaCis treatment and some who did not. These early data suggest that patients predicted sensitive to LiPlaCis (top third) have a 67% probability of response, and a median of 18 weeks to progression. Of the 11 patients with mixed tumor types (where 8 come from the dose escalation cohort and 3 from the ongoing Phase 2 part) 2 patients had a Partial Remission (PR) and 4 patients had Stable Disease (SD). Patients still in LiPlaCis treatment in the ongoing Phase 2 are not included in the analysis. LiPlaCis® is evaluated in an ongoing, multicenter Phase 2 study in metastatic Breast Cancer expected to finalize recruitment in Q3 2017.

"This is good data. We know that LiPlaCis works and we now also a strong indication that the LiPlaCis DRP works in practice. I'm convinced that we have a powerful precision tool," said Adjunct Professor Peter Buhl Jensen, M.D., CEO of MPI. "If these early LiPlaCis DRP results hold, LiPlaCis will be of extraordinary benefit to those patients predicted sensitive ," Peter Buhl Jensen further commented.

Data
The analysis of those patients - where tumor tissue was available -  from the dose escalation phase of the LiPlaCis Phase 1/2 trial has now been completed. A total of 11 patients have been analyzed whereof 3 patients from the Phase 2 part have been included. Patients in ongoing LiPlaCis treatment are not included in the analysis. Of the 11 patients with mixed tumor types (where 8 come from the dose escalation cohort) 2 patients had a Partial Remission (PR) and 4 patients had Stable Disease (SD). The correlation between prediction and response to treatment was 0.5 with a one-sided p-value of 0.06. Due to the small number of patients and mixed tumor types, this is a successful validation of the DRP's ability to predict response. These early data suggest that patients predicted sensitive to LiPlaCis (top third) have a 67% probability of response, and a median of 18 weeks to progression.
These data support the ongoing LiPlaCis development and a future randomized study.

About MPI's 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.

About MPI
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.

About Oncology Venture Sweden AB (OV)
OV is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has a license to use Drug Response Prediction - DRP(TM) - in order to significantly increase the probability of success in clinical trials. DRP(TM) 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 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 2X Oncology Inc. a company focused on developing precision medicine for women's cancer with three anticancer products in pipeline and OV-SPV2 which will test and potentially develop an oral Tyrosine Kinase inhibitor from a Big Pharma the treatment of cancers.

For further information, please contact:
CEO, Peter Buhl Jensen, Adjunct Professor, 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