On May 15, 2019 Sierra Oncology, Inc. (SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that it will report preliminary clinical data from its Phase 1/2 SRA737 monotherapy study and its Phase 1/2 study of SRA737 in combination with low dose gemcitabine (SRA737+LDG) in two posters being presented on June 1st at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois (Press release, Sierra Oncology, MAY 15, 2019, View Source [SID1234536372]).
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In addition, the company will be hosting an Analyst and Investor Event on Monday, June 3rd, to discuss these clinical findings and potential next steps in the development strategy for SRA737.
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 (RS), 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.
"We look forward to presenting preliminary data for these first-in-human studies of SRA737 and SRA737+LDG at ASCO (Free ASCO Whitepaper), and to discussing the potential opportunities for further advancement of our differentiated Chk1 inhibitor that these clinical data provide," said Dr. Nick Glover, President and CEO of Sierra Oncology. "The two studies have enrolled patients across a range of tumor indications including a variety of prospectively selected genetic contexts, allowing us to broadly survey the cancer landscape for activity signals in response to administration of SRA737 alone and in combination with non-cytotoxic low dose gemcitabine. These preliminary data have also enabled us to correlate clinical findings with tumor origin and genetic signature, ascertain whether the exogenous induction of replication stress via low dose gemcitabine can enhance SRA737’s activity, and determine potential next steps in the development path for SRA737."
SRA737 Analyst & Investor Event
Date and Time: June 3rd, 6:00 – 7:00 am CT
Location: History event room, Marriot Marquis Hotel, 2121 S Prairie Ave, Chicago, Illinois.
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.
ASCO 2019 Poster Presentations
Title: A first-in-human phase I/II trial of SRA737 (a Chk1 Inhibitor) in subjects with advanced cancer.
Abstract: 3094
Poster #: 86
Poster Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)
Date and Time: Saturday, June 1, 2019, 8:00 – 11:00 am CT
Location: McCormick Place, Event room: Hall A, 2301 S King Dr, Chicago, Illinois
Title: A phase I/II first-in-human trial of oral SRA737 (a Chk1 inhibitor) given in combination with low-dose gemcitabine in subjects with advanced cancer.
Abstract: 3095
Poster #: 87
Poster Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)
Date and Time: Saturday, June 1, 2019, 8:00 – 11:00 am CT
Location: McCormick Place, Event room: Hall A, 2301 S King Dr, Chicago, Illinois
The posters will be available on June 1, 2019 on the company’s website at www.sierraoncology.com
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 that potentiates SRA737’s anti-tumor activity. Preclinical models have demonstrated that only subtherapeutic levels of gemcitabine are needed to potentiate SRA737’s anti-tumor effect.
Phase 1/2 clinical trials of SRA737 as monotherapy (NCT02797964) and in combination with low dose gemcitabine (NCT02797977) in multiple solid tumors (ovarian, prostate, non-small cell lung, squamous (head & neck, anal), colorectal, small cell lung, sarcoma, cervical, anogenital) are ongoing. Sierra has also prepared for a potential clinical study of SRA737 in combination with a PARP inhibitor.
Sierra Oncology retains the global commercialization rights to SRA737.