Phase 1 Study of PARP Inhibitor 2X-121 Selected as Oral Presentation June 1, 2018
HOERSHOLM, Denmark and CAMBRIDGE, Mass., May 16, 2018 (GLOBE NEWSWIRE) — Oncology Venture AB (OV:ST) (“OV” or the “Company”) 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.|
|Date:||June 1, 2018|
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.|
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.|
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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|Ulla Hald Buhl, COO and||Peter Buhl Jensen, CEO|
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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 a license to use Drug Response Prediction – DRP® – 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 OV model 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 includes: LiPlaCis® for breast cancer; Irofulven 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./Oncology Venture Inc., a U.S.-based company focusing on precision medicine for hard-to-treat cancers with a pipeline of two promising phase 2 product candidates, and OV-SPV 2, a Danish company that will evaluate and potentially develop an oral phase 2 Tyrosine Kinase inhibitor. Oncology Venture currently holds 92 percent of the shares in 2X Oncology Inc. and 40 percent of the shares in OV-SPV 2.