Syros Pharmaceuticals Presents New Preclinical Data Demonstrating Significant Anti-Proliferative Effects of its First-in-Clas...
December 10 2016 - 8:30AM
Business Wire
– SY-1425 Inhibited Tumor Growth as a Single
Agent in Preclinical Models of Drug-Resistant Breast Cancer with
High RARA Gene Expression –
– SY-1425 in Combination with Standard-of-Care
Breast Cancer Therapies Shows Synergistic Effects in Multiple
Preclinical Models –
– Data Highlighted in Late-Breaking
Presentation at San Antonio Breast Cancer Symposium –
Syros Pharmaceuticals (NASDAQ: SYRS) today announced the
presentation of new data on SY-1425, its first-in-class selective
retinoic acid receptor alpha (RARα) agonist, showing that SY-1425
inhibited tumor growth in multiple preclinical models of breast
cancer driven by high levels of RARA gene expression. In these
studies, SY-1425 showed significant anti-proliferative activity
both as a single agent and in combination with standard-of-care
breast cancer therapies in in vitro and in vivo models of breast
cancer, including those resistant to existing treatments. These
data were presented at the 39th Annual San Antonio Breast Cancer
Symposium (SABCS).
“Despite tremendous progress in treating certain types of breast
cancer, two of the greatest remaining challenges are our ability to
identify the right treatment for the right patient and cancer’s
ability to become resistant to treatment,” said Nancy Simonian,
M.D., Chief Executive Officer of Syros. “The new data on SY-1425
show that we have the potential to address both these challenges
for subsets of breast cancer patients whose disease is driven by
abnormally high expression of the RARA gene.”
The data presented at SABCS show that subsets of breast cancer
patients’ tumors have a highly specialized region of regulatory
DNA, known as a super-enhancer, that is associated with the RARA
gene and drives high levels of RARA gene expression. In preclinical
models of breast cancer, high RARA gene expression was shown to be
predictive of response to treatment with SY-1425. The data
highlight that SY-1425:
- Inhibited tumor growth in breast cancer
cell lines as well as cell line-derived xenograft and
patient-derived xenograft models of breast cancer with high RARA
gene expression, including models of HER2-positive breast cancer
resistant to treatment with trastuzumab and ER-positive breast
cancer resistant to hormonal therapies. By contrast, SY-1425 did
not inhibit tumor growth in models of breast cancer with low RARA
gene expression.
- Reduced the expression of genes
responsible for tumor growth in HER2-positive and ER-positive
breast cancer cells with high RARA expression.
- Increased the anti-tumor effects of
standard-of-care therapies, including tamoxifen and palbociclib in
ER-positive breast cancer cells with high RARA expression and
lapatinib in HER2-positive breast cancer cells with high RARA
expression.
These data support the potential clinical development of SY-1425
in genomically defined subsets of breast cancer patients.
SY-1425 is currently in a Phase 2 clinical trial in genomically
defined subsets of acute myeloid leukemia (AML) and myelodysplastic
syndrome (MDS) patients. Using its gene control platform, Syros
discovered subsets of AML, MDS and breast cancer patients whose
tumors have the super-enhancer associated with the RARA gene, which
codes for the RARα transcription factor. The resulting
over-expression of RARα locks the cells in an immature,
undifferentiated and proliferative state. Treatment with SY-1425 in
cancer cells with this super-enhancer promotes differentiation of
these cells. Upon achieving clinical proof-of concept in AML and
MDS, Syros plans to expand development of SY-1425 into genomically
defined subsets of breast cancer patients.
SY-1425 is approved in Japan as Amnolake® (tamibarotene) to
treat relapsed or refractory APL, a form of AML that is driven by a
fusion of the RARA gene with other genes. Syros in-licensed SY-1425
for development and commercialization in North America and Europe
in cancer. Additional details about the ongoing Phase 2 trial in
AML and MDS can be found using the identifier NCT02807558 at
www.clinicaltrials.gov.
About Syros PharmaceuticalsSyros Pharmaceuticals is
pioneering the understanding of the non-coding region of the genome
to advance a new wave of medicines that control expression of
disease-driving genes. Syros has built a proprietary platform that
is designed to systematically and efficiently analyze this
unexploited region of DNA in human disease tissue to identify and
drug novel targets linked to genomically defined patient
populations. Because gene expression is fundamental to the
function of all cells, Syros’ gene control platform has broad
potential to create medicines that achieve profound and durable
benefit across a range of diseases. Syros is currently focused
on cancer and immune-mediated diseases and is advancing a growing
pipeline of gene control medicines. Syros’ lead drug candidates are
SY-1425, a selective RARα agonist in a Phase 2 clinical trial for
genomically defined subsets of patients with acute myeloid leukemia
and myelodysplastic syndrome, and SY-1365, a selective CDK7
inhibitor with potential in a range of solid tumors and blood
cancers. Led by a team with deep experience in drug discovery,
development and commercialization, Syros is located in Cambridge,
Mass.
Cautionary Note Regarding Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995,
including without limitation statements regarding the potential
therapeutic benefits of treatment with SY-1425 as a single agent or
in combination with other agents in genomically defined subsets of
AML, MDS and breast cancer patients, as well as plans to conduct
clinical trials of SY-1425 in combination with other agents. The
words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’
‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’
‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’
‘‘would,’’ and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in these forward-looking statements as a
result of various important factors, including: Syros’ ability to:
advance the development of its programs, including SY-1425, under
the timelines it projects in current and future clinical trials;
obtain and maintain patent protection for its drug candidates and
the freedom to operate under third party intellectual property;
demonstrate in any current and future clinical trials the requisite
safety, efficacy and combinability of its drug candidates;
replicate scientific and non-clinical data in clinical trials;
successfully develop a companion diagnostic test to identify
patients with biomarkers associated with the RARA super-enhancer;
obtain and maintain necessary regulatory approvals; identify, enter
into and maintain collaboration agreements with third parties;
manage competition; manage expenses; raise the substantial
additional capital needed to achieve its business objectives;
attract and retain qualified personnel; and successfully execute on
its business strategies; risks described under the caption “Risk
Factors” in the company’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2016, which is on file with the
Securities and Exchange Commission; and risks described in other
filings that the company makes with the Securities and Exchange
Commission in the future. Any forward-looking statements contained
in this press release speak only as of the date hereof, and Syros
expressly disclaims any obligation to update any forward-looking
statements, whether because of new information, future events or
otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20161210005001/en/
Media Contact:Syros Pharmaceuticals, Inc.Naomi Aoki,
617-283-4298naoki@syros.comorInvestor Contact:Stern Investor
Relations, Inc.Hannah Deresiewicz,
212-362-1200hannahd@sternir.com
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