- Corporate prioritization of portfolio to focus
resources on advancement of momelotinib -
- Exploring non-dilutive options to support future continued
development of SRA737 and SRA141 -
VANCOUVER, June 27, 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, today announced
plans to prioritize its existing resources on the development of
momelotinib, its differentiated Phase 3 drug candidate for the
treatment of patients with myelofibrosis. Sierra also announced it
has launched a campaign exploring non-dilutive strategic options to
support the future continued development of its portfolio of potent
and selective DDR (DNA Damage Response) assets, consisting of
SRA737 (Chk1 inhibitor) and SRA141 (Cdc7 inhibitor).
"We recently reported compelling proof-of-concept clinical
efficacy data for SRA737 at the 2019 ASCO Annual Meeting,
demonstrating that this drug candidate has notable anti-cancer
activity in multiple indications and a defined clinical path
forward towards potential initial registration for the treatment of
anogenital cancer, an indication with considerable unmet need. For
SRA141, we have demonstrated a potentially novel mechanism of
cytotoxicity and successfully completed the IND process with
the FDA enabling the commencement of clinical trials," said Dr.
Nick Glover, President and CEO of
Sierra Oncology. "While we continue to advance the assets in our
DDR portfolio and view them as promising oncology drug candidates
that warrant further development, we are prioritizing our resources
on our lead drug, momelotinib. To support the continued development
of SRA737 and SRA141 in the future, we intend to seek non-dilutive
strategic options."
About Sierra's DDR assets: SRA737 (targeting Chk1) and SRA141
(targeting Cdc7)
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. SRA737+LDG
is a novel drug combination, where non-cytotoxic low dose
gemcitabine (LDG) acts as a potent extrinsic inducer of replication
stress.
At the 2019 ASCO Annual meeting, Sierra reported preliminary
efficacy data for SRA737 including a 30% Overall Response Rate in
patients with anogenital cancer treated with SRA737+LDG , 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 across multiple indications, with an Overall Response Rate
of 25% and Disease Control Rate of 81%.
Sierra has conducted preclinical research demonstrating SRA737
synergy in combination with other DDR-targeted agents including
poly ADP-ribose polymerase (PARP) inhibitors, as well as with
immuno-oncology therapeutics. Sierra has an agreement with Janssen
Research & Development, LLC (Janssen), under which Janssen has
agreed to supply the PARP inhibitor niraparib, facilitating the
potential initiation of a combination trial with SRA737 that Sierra
has designed for the treatment of prostate cancer. Sierra reported
preclinical data in a late-breaking poster presented at the AACR
Annual Meeting 2019 demonstrating that SRA737+LDG activates innate
immune signaling and establishes an anti-tumor immune
microenvironment that profoundly synergizes with immune checkpoint
inhibitors. Sierra has reported having management support from a
major immuno-oncology company to potentially supply their leading
immunotherapeutic agent to run a combination study with SRA737.
SRA141 is a potent, selective, orally bioavailable small
molecule inhibitor of Cell division cycle 7 kinase (Cdc7). Sierra
reported preclinical data in a late-breaking poster presented at
the AACR Annual Meeting 2019 highlighting a possible novel
mechanism of cytotoxicity for SRA141 that is distinct from other
agents, in which SRA141 alters DNA replication dynamics and delays
cell cycle progression, leading to apoptotic tumor cell death. This
differentiated mechanism of action may support a unique spectrum of
clinical opportunities for SRA141 as both monotherapy and in
combination with pro-apoptotic and mitotic disrupting agents.
Sierra has successfully completed the IND process with the U.S.
Food and Drug Administration (FDA) for SRA141 and has designed a
potential Phase 1/2 trial with this drug candidate.
Sierra Oncology retains the global commercialization rights to
SRA737 and SRA141.
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.
Momelotinib, Sierra's lead drug candidate, is a potent,
selective and orally-bioavailable JAK1, JAK2 & ACVR1 inhibitor
with a differentiated therapeutic profile in myelofibrosis
encompassing robust constitutional symptom improvements, a range of
meaningful anemia benefits, including eliminating or reducing the
need for frequent blood transfusions, and comparable spleen control
to ruxolitinib. More than 1,200 subjects have received momelotinib
since clinical studies began in 2009, including more than 800
subjects treated for myelofibrosis.
Sierra plans to launch the MOMENTUM Phase 3 clinical trial in Q4
2019 to support potential registration of the momelotinib on a
global basis. The randomized double-blind trial is designed to
enroll 180 myelofibrosis patients who are symptomatic, anemic and
have been treated previously with a JAK inhibitor. Dr. Srdan
Verstovsek, MD, PhD, Chief, Section for Myeloproliferative
Neoplasms, Department of Leukemia, Division of Cancer Medicine, The
University of Texas MD Anderson Cancer
Center, Houston, Texas, has been
named Chief Investigator of the MOMENTUM trial.
Momelotinib is wholly owned by Sierra Oncology and is covered by
patents anticipated to provide potential exclusivity to 2040 in the
U.S. The FDA has granted Fast Track designation to momelotinib for
the treatment of patients with intermediate/high-risk myelofibrosis
who have previously received a JAK inhibitor.
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, expected timing
of the execution of, and expected results from, non-dilutive
strategic options, expected timing of the initiation of MOMENTUM,
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