- Sierra management and distinguished oncologists
Professor Johann de Bono and Dr.
Rebecca Kristeleit discuss clinical findings and possible next
steps for SRA737 -
- Sierra reported SRA737 activity, including 30% response rate for
SRA737+LDG in anogenital cancer, in preliminary Phase 1/2 data
presented at the 2019 ASCO Annual Meeting –
- Regulatory clarity for Sierra's lead asset momelotinib
anticipated in the near-term -
VANCOUVER, June 3, 2019 /CNW/ - 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 holding 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.
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) 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 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.
About Sierra Oncology
Sierra Oncology is a clinical
stage drug development company advancing targeted therapeutics for
the treatment of patients with unmet medical needs in hematology
and oncology. Our lead drug candidate, momelotinib, is a potent,
selective and orally bioavailable JAK1, JAK2 and ACVR1 inhibitor
that has been investigated in two completed Phase 3 trials for the
treatment of myelofibrosis and has demonstrated a potentially
differentiated therapeutic profile encompassing anemia-related
benefits, as well as achieving substantive splenic volume reduction
and constitutional symptom control.
Sierra Oncology is also advancing SRA737 and SRA141. 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). SRA141 is a
potent, selective, orally bioavailable small molecule inhibitor of
Cell division cycle 7 kinase (Cdc7). Cdc7 is a key regulator of DNA
replication and is involved in the DDR network, making it a
compelling emerging target for the potential treatment of a broad
range of tumor types.
For more information, please visit www.sierraoncology.com.
Cautionary Note on Forward-Looking Statements
This
press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995, including, but not limited to,
statements regarding Sierra Oncology's expectations from current
data, anticipated clinical development activities, time of
regulatory communications and potential benefits of Sierra
Oncology's product candidates. All statements other than statements
of historical fact are statements that could be deemed
forward-looking statements. These statements are based on
management's current expectations and beliefs and are subject to a
number of risks, uncertainties and assumptions that could cause
actual results to differ materially from those described in the
forward-looking statements. Such forward-looking statements are
subject to risks and uncertainties, including, among others, the
risk that Sierra Oncology may be unable to successfully develop and
commercialize product candidates, product candidates may not
demonstrate safety and efficacy or otherwise produce positive
results, Sierra Oncology may experience delays in the preclinical
and anticipated clinical development of its product candidates,
Sierra Oncology may be unable to acquire additional assets to build
a pipeline of additional product candidates, Sierra Oncology's
third-party manufacturers may cause its supply of materials to
become limited or interrupted or fail to be of satisfactory
quantity or quality, Sierra Oncology's cash resources may be
insufficient to fund its current operating plans and it may be
unable to raise additional capital when needed, Sierra Oncology may
be unable to obtain and enforce intellectual property protection
for its technologies and product candidates and the other factors
described under the heading "Risk Factors" set forth in Sierra
Oncology's filings with the Securities and Exchange Commission from
time to time. Sierra Oncology undertakes no obligation to update
the forward-looking statements contained herein or to reflect
events or circumstances occurring after the date hereof, other than
as may be required by applicable law.
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SOURCE Sierra Oncology