1st RNS27 Feb 2018 12:21
VANCOUVER, Feb. 27, 2018 /CNW/ - Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation 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), an orally administered poly (ADP-ribose) polymerase (PARP) inhibitor undergoing clinical development by Janssen for patients with prostate cancer. Sierra intends to evaluate its Chk1 inhibitor, SRA737, in combination with niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC). The scientific rationale for the combination was supported by translational research conducted at The Institute of Cancer Research, London.
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. He noted: "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."
"Preclinical studies have demonstrated synergy between PARP inhibitors and SRA737, including in contexts where PARP inhibitors have minimal activity such as HRR proficient and PARP inhibitor resistant settings," added Dr. Nick Glover, President and CEO of Sierra Oncology. "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."
"This supply agreement with Janssen is significant strategically in the continued advancement of SRA737 as it enables the exploration of a novel and independent development path for our Chk1 inhibitor, supported by both a promising scientific and a compelling commercial rationale," added Dr. Angie You, Chief Business & Strategy Officer and Head of Commercial at Sierra.
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