Phase 1 Study of PARP Inhibitor 2X-121 selected as oral Presentation June 1, 2018
Hoersholm, Denmark and Cambridge, MA – May 16, 2018 – Medical Prognosis Institute A/S (MPI:ST) (“MPI” or “Medical Prognosis Institute” and Oncology Venture AB (OV:ST) (“OV” or “Oncology Venture”) announced today that three abstracts detailing clinical trials of its product candidates have been accepted by the American Society for Clinical Oncology (ASCO) for the 2018 ASCO Clinical Meeting.
Notably, Ruth Plummer, MD, PhD, FRCP, will present an abstract describing the first-in-human Phase 1 study of 2X-121, an investigational PARP 1/2 and tankyrase 1/2 inhibitor, as monotherapy in patients with advanced solid tumors.
Abstract Title: First-in-human phase 1 study of the PARP/tankyrase inhibitor 2X-121 (E7449) as monotherapy in patients with advanced solid tumors and validation of a novel drug response predictor (DRP®) mRNA biomarker.
Abstract No.: 224139
Date: June 1, 2018
Time: 4:09pm CDT
In addition to evaluating the safety, maximum tolerated dose, and anti-tumor efficacy of 2X-121, the study also assessed the ability of a novel tumor agnostic molecular biomarker to identify responders and non-responders to 2X-121. This companion diagnostic, called the 2X-121 DRP®, is based on expression of 414 genes predictive of response to 2X-121.
Following completion of the study, the 2X-121 DRP® was applied in a blinded manner following a pre-specified analysis plan. The 2X-121 DRP® successfully predicted the responders to treatment with 2X-121, irrespective of BRCA mutation status.
OV in-licensed this anti-cancer agent (formerly E7449) from Eisai Inc. in July 2017. Oncology Venture will initiate a Phase 2, open-label clinical study to investigate the anti-tumor effect and tolerability of 2X-121 in patients with metastatic breast cancer (mBC) selected by the 2X-121 DRP®.
Dr. Plummer is director of the Sir Bobby Robson Cancer trials Research Centre at the Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK, and was the primary investigator of this study. She is a member of the Cancer Research UK (CRUK) Science Funding committee and chair of the CRUK New Agents Committee.
Two additional abstracts on OV pipeline products were accepted by ASCO as electronic abstracts as follows:
Abstract Title: Liposomal cisplatin response prediction in heavily pretreated breast cancer patients: A multigene biomarker in a prospective phase 2 study.
Abstract No.: e13077
LiPlaCis is a lipid formulation of cisplatin, one of the most widely used drugs in the treatment of cancer. This improved formulation enables a more selective up-take of cisplatin at the tumour site. Once it has accumulated in the cancer tissue, the LiPlaCis is broken down by secretory phospholipase A2 (sPLA2), an enzyme present on tumors. The lipid composition of LiPlaCis is tailored to be specifically sensitive to degradation by the sPLA2 enzyme and thereby for release of the encapsulated cisplatin.
Abstract Title: Characterization of resistance to APO010, a recombinant hexameric FAS ligand, in human myeloma cell lines.
Abstract No.: e20025
APO010 is a recombinant, soluble, hexameric fusion protein consisting of three human Fas ligand (FasL) extracellular domains fused to the dimer-forming collagen domain of human adiponectin with potential pro-apoptotic and antineoplastic activities. Assembled into a soluble hexameric structure mimicking the ligand clustering of endogenous active FasL, APO010 activates the Fas receptor, resulting in caspase-dependent apoptosis in susceptible tumor cell populations. FasL is a transmembrane protein of the tumor necrosis factor (TNF) superfamily and a pro-apoptotic ligand for the death receptor Fas.
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About MPI’s multiple biomarker called Drug Response Predictor – DRP®
MPI’s DRP® 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® has been tested in 37 trials, where 29 trials showed that drug-specific DRP® Biomarkers could predict which patients responded well to the treatment. The DRP® platform has amongst others been externally validated and published in collaboration with leading statisticians at the MD Anderson Cancer Center. The DRP® 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® 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® is a Big Data tool based on messenger RNA. The DRP® 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 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 1,000 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. MPI has ownership of Oncology Venture (Publ) a spinout with three anti-cancer drugs in pipeline entered and of the privately hold Special Purpose Vehicles, 2X Oncology Inc. and OV-SPV2 Aps with four products in pipeline.
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