Syros Announces Issuance of U.S. Patents Covering Methods for Stratifying Patients for Treatment with SY-1425, Its First-in-Class Selective RARα Agonist

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the development of medicines to control the expression of genes, today announced that the U.S. Patent and Trademark Office has issued two patents covering methods for stratifying patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) for treatment with SY-1425 (tamibarotene), the Company’s first-in-class selective retinoic acid receptor alpha (RARα) agonist.

The first patent, U.S. Patent 9,845,508, covers a method of diagnosing and treating AML patients by determining whether they have elevated levels of RARA messenger RNA (mRNA) and, if they do, administering SY-1425. The second patent, U.S. Patent 9,868,994, covers a method of treating AML and MDS by administering SY-1425 to patients known to have elevated levels of IRF8 mRNA. For purposes of these patents, AML does not include acute promyelocytic leukemia, or APL.

Using its gene control platform, Syros identified subsets of AML and MDS patients with a highly specialized regulatory region of DNA, known as a super-enhancer, associated with either the RARA or IRF8 gene, or both. The Company is using a clinical trial assay to identify AML and MDS patients with elevated levels of RARA and IRF8 mRNA for inclusion in a Phase 2 clinical trial assessing the safety and efficacy of SY-1425 in combination with azacitidine, a hypomethylating agent, and in combination with daratumumab, an anti-CD38 therapeutic antibody.

Syros continues to prosecute additional patent applications generally covering methods of stratifying patients for treatment with RARα agonists. The Company believes that each of its recently issued U.S. patents are eligible for listing in the U.S. Food and Drug Administration’s Orange Book and would expire no earlier than 2036.

About Syros Pharmaceuticals

Syros is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control expression of 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 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 myelodysplastic syndrome, and SY-1365, a selective CDK7 inhibitor in a Phase 1 clinical trial for patients with advanced solid tumors. 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 term of the patents recently issued to Syros and the eligibility for such patents to be listed in the FDA’s Orange Book, and the benefits of Syros’ gene control platform. The Company can provide no assurance that its recently issued patents will remain free from challenge or can otherwise be successfully enforced against third parties. 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; 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 the RARA and IRF8 biomarkers; obtain and maintain patent protection for its drug candidates, including additional patent applications covering methods of stratifying patients for treatment with RARα agonists, 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; the ability of our collaboration partners to satisfy their obligations under our collaboration agreements; manage competition; and successfully execute on its business strategies; risks described under the caption “Risk Factors” in Syros’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, 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.

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