On May 16, 2018 Oncology Venture AB (OV:ST) ("OV" or the "Company") reported that three abstracts detailing clinical trials of its product candidates have been accepted by the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) for the 2018 ASCO (Free ASCO Whitepaper) Clinical Meeting (Press release, 2X Oncology, MAY 16, 2018, View Source [SID1234526692]).
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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.: 2505
Date: June 1, 2018
Time: 4:09pm CDT
Location: S406
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 (Free ASCO Whitepaper) as electronic abstracts as follows:
LiPlaCis
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.
APO010
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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