On June 3, 2019 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, is reported an analyst and investor event today featuring distinguished oncologists Professor Johann de Bono and Dr. Rebecca Kristeleit, to discuss clinical findings and possible next steps for its oral, highly selective Chk1 inhibitor, SRA737 (Press release, Sierra Oncology, JUN 3, 2019, View Source [SID1234536813]).
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On Saturday, June 1st, Sierra reported positive preliminary clinical data from its two first-in-human Phase 1/2 studies of SRA737, as monotherapy and as SRA737+LDG (low dose gemcitabine), at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago. Detailed results were issued by press release on June 1st and are available on Sierra’s website at www.sierraoncology.com. Anti-cancer activity was demonstrated across multiple indications and genetic contexts, with SRA737+LDG specifically achieving a notable 30% response rate in anogenital cancer patients, an indication for which the second line metastatic setting represents a significant unmet medical need with no approved therapies and very poor life expectancy. Additionally, subjects whose tumors harbored FA/BRCA gene network mutations displayed favorable outcomes, including an Overall Response Rate = 25% and Disease Control Rate = 81%.
"These positive data indicate that SRA737 is a demonstrably active anti-cancer drug that we believe warrants further development. The initial efficacy and favorable tolerability profile described at ASCO (Free ASCO Whitepaper) also enables several potentially promising opportunities for its development in combination with other therapeutics, in particular with PARP inhibitors and immunotherapy agents where we have previously reported robust preclinical efficacy data," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We also look forward to announcing regulatory clarity for our lead asset momelotinib in the near-term. We have been holding productive discussions with regulators and continue to prepare for a Phase 3 clinical trial intended to potentially support its registration. Given momelotinib is our lead drug candidate and highest priority, we will be exploring options to enable the continued advancement of SRA737 in the context of our emerging pipeline."
SRA737 Analyst & Investor Event
The company is hosting an Analyst and Investor Event on Monday, June 3, 2019, to discuss these clinical findings and potential next steps in the development strategy for SRA737+LDG.
Date and Time: June 3, 2019, 6:00 – 7:00 am CT
Location: History event room, Marriot Marquis Hotel, 2121 S Prairie Ave, Chicago, Illinois.
The event will feature presentations by two distinguished oncologists:
Professor Johann de Bono, Regius Professor of Cancer Research, Head of the Division of Clinical Studies and Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, will discuss the critical role of Chk1 in tumor cell survival during replication stress, as well as describe potential opportunities to combine SRA737 with other therapeutic modalities including PARP inhibitors and immunotherapy agents.
Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Honorary Consultant Medical Oncologist at University College London (UCL) Cancer Institute & UCLH Dept. of Oncology, a leading expert in gynecological malignancies, will discuss her clinical experience with SRA737+LDG, and potential development opportunities for this novel combination in the treatment of anogenital cancers.
Event registration and webcast information are available through the Sierra Oncology website at www.sierraoncology.com. An archive of the presentation will be accessible after the event through the Sierra Oncology website.
About SRA737 and SRA737+LDG
SRA737 is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell cycle progression and the DNA Damage Response (DDR). Tumors with high levels of replication stress become reliant on Chk1 to mitigate the potentially catastrophic consequences of excess genomic instability.
Intrinsic sources of replication stress can include genetic alterations in tumor suppressors, oncogenes or DNA Damage Repair genes. Tumors harboring defects in these gene classes are hypothesized to have higher levels of intrinsic replication stress due to dysregulated cell cycle control, increased proliferation demands and increased genomic instability. SRA737+LDG is a novel drug combination, where non-cytotoxic low dose gemcitabine (LDG) acts as a potent extrinsic inducer of replication stress.
Sierra Oncology retains the global commercialization rights to SRA737.