New Publication in Cancer Research Highlights Discovery of SY-1365, a First-in-Class Selective CDK7 Inhibitor, & its Promise ...
May 07 2019 - 8:31AM
Business Wire
SY-1365 Currently in Phase 1 Clinical Trial in
Relapsed and Treatment-Resistant Ovarian and Breast Cancer
Patients
Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the
development of medicines that control the expression of genes,
today announced the online publication of a new manuscript,
Discovery and Characterization of SY-1365, a Selective, Covalent
Inhibitor of CDK7, in the American Association for Cancer
Research’s (AACR) journal, Cancer Research. SY-1365, a
first-in-class selective cyclin-dependent kinase 7 (CDK7)
inhibitor, is currently being investigated in a Phase 1 clinical
trial as a single agent and in combination with standard-of-care
therapies in multiple ovarian and breast cancer patient populations
that lack effective treatment options. This publication highlights
the discovery, mechanism of action and promise of SY-1365 as a new
targeted approach for a range of difficult-to-treat cancers.
“SY-1365 represents a potentially transformative targeted
approach for a number of cancers that have eluded treatment with
existing approaches,” said Eric R. Olson, Ph.D., Syros’ Chief
Scientific Officer. “While CDK7 has long been a target of interest,
it was historically difficult-to-drug. This new publication
profiles our work in discovering SY-1365, which we believe to be
the most advanced selective CDK7 inhibitor in clinical development,
and the substantial anti-tumor activity seen in preclinical models
that supported its advancement into the clinic. We are excited by
the promise of CDK7 inhibition and the potential benefit SY-1365
may bring to patients who are in dire need of better
therapies.”
Syros is currently conducting a Phase 1 clinical trial assessing
the safety and efficacy of SY-1365 as a single agent and in
combination with standard-of-care therapies in multiple ovarian and
breast cancer patient populations. The trial includes cohorts
evaluating SY-1365 as a single agent in patients with relapsed
ovarian clear cell cancer and in high-grade serous ovarian cancer
(HGSOC) patients who have had three or more prior lines of therapy;
in combination with carboplatin in HGSOC patients who have had one
or more prior lines of therapy; in combination with fulvestrant in
metastatic hormone receptor-positive breast cancer patients who are
resistant to treatment with a CDK4/6 inhibitor; and as a single
agent in patients with solid tumors of any histology accessible for
biopsy. Additional details about the trial can be found using the
identifier NCT03134638 at www.clinicaltrials.gov.
CDK7 plays a key role in the transcription of genes and in cell
cycle regulation, and inhibiting CDK7 disrupts two important
processes that cancer cells use to survive: 1) expression of
cancer-promoting genes; and 2) uncontrolled cell cycle progression.
SY-1365 has shown anti-tumor activity in preclinical models of a
range of solid tumors and blood cancers, including cancers that
have become resistant to treatment with existing therapies or where
existing options have failed to provide meaningful benefit to
patients. Further, data suggests that SY-1365 works to inhibit the
growth of cell lines representing many different cancer types at
nanomolar concentrations, decreases MCL1 protein levels, and
demonstrates activity among cancer cells with low BCL-XL
expression.
Building on its leadership in CDK7 inhibition, Syros is
advancing SY-5609, a highly selective and potent oral CDK7
inhibitor, toward clinical development. In preclinical studies,
SY-5609 has demonstrated substantial anti-tumor activity, including
inducing complete regressions in cell line-derived xenograft models
of breast and ovarian cancers. The company plans to complete
investigational new drug application (IND)-enabling studies by the
end of 2019 to support the initiation of a Phase 1 oncology trial
in early 2020.
About Syros PharmaceuticalsSyros is pioneering the
understanding of the non-coding regulatory region of the genome to
advance a new wave of medicines that control the expression of
genes. Syros has built a proprietary platform that is designed to
systematically and efficiently analyze this unexploited region of
DNA 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 monogenic 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 SY-1365, a selective CDK7 inhibitor in a Phase 1
clinical trial focused on patients with ovarian and breast cancers.
Syros is also developing a deep preclinical and discovery pipeline,
including SY-5609, an oral CDK7 inhibitor, as well as programs in
immuno-oncology and sickle cell disease. 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 promise of
selective CDK7 inhibition and the potential benefit of SY-1365 as a
therapeutic approach for difficult to treat cancers; the ability to
complete IND-enabling preclinical studies and begin clinical
development of SY-5609; and the benefits of Syros’ gene control
platform and product development pipeline. The words
‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’
‘‘expect,’’ “hope,” ‘‘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-1365, under the timelines it projects in
current and future clinical trials; demonstrate in any current and
future clinical trials the requisite safety, efficacy and
combinability of its drug candidates; successfully progress SY-5609
through IND-enabling preclinical and toxicology studies; replicate
scientific and non-clinical data in clinical trials; obtain and
maintain patent protection for its drug candidates and the freedom
to operate under third party intellectual property; obtain and
maintain necessary regulatory approvals; identify, enter into and
maintain collaboration agreements with third parties, including its
ability to perform under the collaboration agreement with Incyte;
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 Syros’ Annual Report on Form 10-K for the year ended
December 31, 2018, which is on file with the Securities and
Exchange Commission; and risks described in other filings that
Syros 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190507005133/en/
Media Contact:Naomi AokiSyros
Pharmaceuticals617-283-4298naoki@syros.com
Investor Contact:Hannah DeresiewiczStern Investor
Relations, Inc.212-362-1200hannah.deresiewicz@sternir.com
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