Sierra Oncology signs Supply Agreement for Prostate Cancer Study
Sierra Oncology which is a clinical stage drug development company aiming to further the DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, today announced the signing of a clinical supply agreement with Janssen Research & Development, LLC. (Janssen) for access to TESARO’s ZEJULA (niraparib).
Professor Johann de Bono, Regius Professor of Cancer Research at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, will be the Chief Investigator of the new study stated “I look forward to supporting Sierra’s investigation of this combination. Research has demonstrated the potential benefit of PARP inhibitor therapy in prostate cancer patients with defects in HRR, and clinical trials are under way evaluating niraparib in these patients. However, the combination of Chk1 inhibition with PARP inhibition potentially may expand the application of niraparib to patients with HRR proficient tumors or re-sensitize patients who have developed PARP inhibitor resistance.”
Dr. Nick Glover, President and CEO of Sierra Oncology said “PARP inhibitors impede the repair of single-strand DNA breaks, resulting in stalled DNA replication forks and double strand breaks that make the cell highly reliant on HRR, which is regulated by Chk1. The combined inhibition of both pathways is the basis for Sierra’s drug combination strategy of SRA737 with niraparib.”
Janssen will provide Sierra with niraparib, while Sierra will conduct and control the study, which is anticipated to commence in the fourth quarter of 2018. Sierra plans to conduct an open-label, multicenter Phase 1b/2 dose-ranging study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SRA737 in combination with niraparib in patients with mCRPC. The study is intended to determine the maximum tolerated dose and schedule of SRA737 in combination with niraparib and to propose a recommended Phase 2 dose (RP2D) and schedule of the combination.