CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Syros Pharmaceuticals (NASDAQ: SYRS) today announced that new data on its lead candidate, SY-1425, a selective retinoic acid receptor alpha (RARα) agonist currently in Phase 2 clinical development in genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), will be highlighted in two presentations at the 58th American Society of Hematology (ASH) Annual Meeting and Exhibition taking place December 3-6, 2016, in San Diego.
The new preclinical data will demonstrate that SY-1425 produces a biologic response in in vitro models of AML with high levels of RARA gene expression similar to that seen in models of acute promyelocytic leukemia (APL), while having little effect on AML cells with low levels of RARA gene expression. APL is a form of AML with a distinct genetic alteration in the RARA gene. SY-1425 is approved in Japan for the treatment of APL, with a well-established efficacy and safety profile. The consistent biological responses suggest that SY-1425 may provide a clinical benefit for subsets of AML patients whose tumors are driven by high levels of RARA as it does in APL patients. In both diseases, RARα is a key oncogenic driver directly targeted by SY-1425.
The presentations also will detail the identification of pharmacodynamic markers to measure the biological activity of SY-1425 in an ongoing Phase 2 clinical trial in order to provide an early indicator that the drug is affecting the targeted biology in AML and MDS patients. Lastly, the preclinical data will show that SY-1425 increases the anti-tumor activity of chemotherapy and hypomethylating agents, supporting the potential development of SY-1425 as a combination therapy with these standard-of-care treatments for AML and MDS patients.
Details on the presentations are as follow:
Date & Time: Saturday, December 3, from 5:30 - 7:30 p.m. PST
Presentation
Title: SY1425 (tamibarotene) Induces Profound Transcriptional Changes in
AML Tumors with High Retinoic Acid Receptor Alpha
Session: 602.
Disordered Gene Expression in Hematologic Malignancy, including
Disordered Epigenetic Regulation: Poster I
Presenter: Christopher
Fiore, Ph.D., Scientist, Syros Pharmaceuticals
Abstract Number: 1523
Location:
San Diego Convention Center, Hall GH
Date & Time: Sunday, December 4, 2016, from 6 - 8 p.m PST
Presentation
Title: Clinical Pharmacodynamic Markers and Combinations with SY-1425
(tamibarotene) in a Genomically Defined Subset of Non-APL AML
Session
Title: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular
Markers
in Diagnosis and Prognosis: Poster II
Presenter:
Michael R. McKeown, Ph.D., Senior Scientist, Syros Pharmaceuticals
Abstract
Number: 2898
Location: San Diego Convention Center, Hall GH
Using its gene control platform, Syros discovered subsets of AML and MDS patients whose tumors have a highly specialized regulatory region of non-coding DNA, known as a super-enhancer, that is associated with the RARA gene, which codes for the RARα transcription factor. The super-enhancer is believed to lead to over-expression of the RARα transcription factor, locking cells in an immature, undifferentiated and proliferative state. Syros further investigated this unique biology directly in patient tissues and conducted preclinical studies showing that the RARA super-enhancer is predictive of response to treatment with SY-1425 in preclinical AML models, providing a strong rationale for developing SY-1425 in subsets of AML and MDS patients with the RARA super-enhancer. Syros in-licensed SY-1425 for development and commercialization in North America and Europe in cancer.
About Syros Pharmaceuticals
Syros 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 Statements
This
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 in genomically defined subsets of AML and MDS
patients as well as treatment with SY-1425 in combination with other
agents in AML and MDS patients. 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 June 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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