On June 26, 2018 Oncology Venture US Inc., Oncology Venture AB (OV:ST) ("OV") and Medical Prognosis Institute A/S (MPI:ST) reported dosing of the first patient in a Phase 2, open-label clinical trial to investigate the anti-tumor effect and tolerability of 2X-121 in patients with metastatic breast cancer selected by a novel drug response predictor (DRP) mRNA-driven multiple biomarker, the 2X-121 DRP (Press release, 2X Oncology, JUN 26, 2018, View Source [SID1234527477]). The drug is being developed by Oncology Venture US Inc. (formerly 2X Oncology Inc.).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"This targeted Phase 2 study will enable us to rapidly evaluate the efficacy of our Tankyrase and PARP inhibitor in heavily pre-treated metastatic breast cancer patients, using the 2X-121 DRP to prospectively select likely responders to this differentiated therapy," said George Elston, CEO of Oncology Venture US Inc.
2X-121 is an orally-available small molecule PARP and tankyrase inhibitor. This clinical trial is designed to enroll 30 metastatic breast cancer patients regardless of hormone receptor, HER2 status and BRCA1 or 2 status, who have relapsed on two or more different prior therapies and who are identified by the 2X-121 DRP as highly likely to respond to treatment with 2X-121.
The 2X-121 DRP is a novel, tumor-agnostic (i.e. independent of tumor site) molecular biomarker based on expression of 414 genes predictive of response to 2X-121. In a study presented at ASCO (Free ASCO Whitepaper), the 2X-121 DRP correctly identified responders and non-responders to treatment irrespective of BRCA mutation status. Although a patient’s BRCA status is used to identify potential responders for treatment with approved PARP inhibitors, other likely responders are excluded. The 2X-121 DRP biomarker is expected to identify those patients who are likely responders while excluding the likely non-responders.
In this clinical trial, patients will receive oral treatment with 600 mg of 2X-121, as a single agent, in a 21-day cycle. The primary endpoint of this study is clinical benefit rate, defined as complete response, partial response, or stable disease at greater than 24 weeks post-treatment using the RECIST criteria. Secondary endpoints include progression free survival, duration of response (from first response to progression), and overall survival.
2X-121 Phase 2 study in metastatic Breast Cancer (mBC)
2X-121 is an investigational, orally-available small molecule targeted inhibitor of Poly ADP ribose polymerase (PARP), a key enzyme involved in DNA damage repair in cancer cells. The drug candidate has a novel dual-inhibitory action against both PARP 1/2 and Tankyrase 1/2. The molecule is also active in P-glycoprotein expressing cells, suggesting it may overcome PARP inhibitor resistance. Patients will receive oral treatment with 600 mg 2X-121, as a single agent, in a 21-day cycle. The primary endpoint of this study is clinical benefit rate defined as complete response, partial response, or stable disease at greater than 24 weeks post-treatment using the RECIST criteria. Secondary endpoints include progression free survival, duration of response (from first response to progression), and overall survival.
Separate, targeted Phase 2 studies of 2X-121 are planned using the validated DRP biomarker in recurrent ovarian cancer, castration resistant prostate cancer, and pancreatic cancer to identify patients likely to respond to and benefit from treatment with the drug.
About the Drug Response Predictor – DRP Companion Diagnostic
Oncology Venture uses the Medical Prognosis Institute (MPI) multi gene DRP to select those patients who by the genetic signature of their cancer are found to have a high likelihood of responding to the drug. The goal is developing the drug for the right patients, and by screening patients before treatment the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. DRP is based on messenger RNA from the patient’s biopsies.
The DRP platform, i.e. the DRP and the PRP tools, can be used in all cancer types and is patented for more than 70 anti-cancer drugs in the US. The PRP is used by MPI for Personalized Medicine. The DRP is used by Oncology Venture for drug development.
DRP is a registered trademark of Medical Prognosis Institute A/S.