Full Press Release Details
Syros Announces New Data from Phase 2 Trial of SY-1425 in
Combination with Azacitidine Demonstrating High Response Rates, Rapid Onset of Action and Favorable Tolerability Profile in RARA-Positive Newly Diagnosed Unfit AML Patients
62% Composite Complete Response Rate, with 82% of Patients Achieving or Maintaining Transfusion Independence
Data Support RARA as the Optimal Predictive Biomarker for Patient Selection
CAMBRIDGE, Mass., October 24, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of
genes, today announced that updated clinical data from its ongoing Phase 2 trial evaluating SY-1425, its first-in-class selective
retinoic acid receptor alpha (RAR ) agonist, in combination with azacitidine, continue to demonstrate high complete response rates, rapid onset of action and a favorable tolerability profile in a genomically defined subset of newly diagnosed
acute myeloid leukemia (AML) patients who are not suitable candidates for standard intensive chemotherapy. These data are being presented at the European School of Haematology (ESH) 5th
International Conference Acute Myeloid Leukemia Molecular and Translational : Advances in Biology and Treatment in Estoril, Portugal.
am very encouraged by these data. AML patients continue to need new treatment options, despite recent advances in the field, that are well-tolerated and can be used in combination to extend survival and improve quality of life, said
St phane de Botton, M.D., Head of Acute Myeloid Malignancies at Institut Gustave Roussy and a clinical investigator in the Phase 2 trial of SY-1425. These data show that SY-1425, a targeted therapy, in combination with azacitidine is highly active in a subset of patients that can be readily identified and that the combination is generally well-tolerated even in very sick AML
patients. I believe SY-1425 is a promising combination agent with the potential to provide a meaningful benefit for a subset of AML patients, and I look forward to its continued development.
These data mark an important milestone in the development of SY-1425, said David A. Roth, M.D., Chief
Medical Officer of Syros. SY-1425 in combination with azacitidine continues to demonstrate high complete response rates, rapid onset of action and a favorable tolerability profile in RARA-positive
AML patients. As we study the combination in more patients, we are also seeing a high rate of transfusion independence and early evidence of durable responses. We are gratified to see our discovery of this novel patient subset, as defined by our
RARA biomarker, translating into clinical benefit. These results demonstrate the power of our gene control platform to identify which genes to modulate in which patients to maximize the chances of providing them with a profound benefit. We look
forward to continuing to evaluate SY-1425 in our ongoing study and to reporting potential proof-of-concept data next year in
RARA-positive relapsed or refractory AML patients.
Updated Clinical Data on SY-1425 in Combination with
Azacitidine in Newly Diagnosed, Unfit AML Patients
Syros presented updated data from its Phase 2 trial of
SY-1425 in combination with azacitidine, a standard-of-care hypomethylating agent, in newly diagnosed unfit AML patients. The
trial evaluated the safety and efficacy of the combination in patients with either the RARA or IRF8 biomarker, as well as in patients without the biomarkers. All patients were treated with azacitidine administered at standard daily doses of
75 mg/m2 intravenously or subcutaneously for seven days, followed by SY-1425 administered at 6
mg/m2/day orally, divided in two doses, for the remainder of each 28-day cycle.
As of Aug. 22, 2019, 40 newly diagnosed unfit AML patients had been enrolled in the trial and were eligible for the safety analysis. The median age of
patients enrolled in the study was 76. Of the 17 biomarker-positive patients evaluable for response, 13 were RARA-positive and four were IRF8-positive. Enrollment in the newly diagnosed unfit cohorts of the ongoing Phase 2 trial is nearly
complete. Syros will continue to follow patients enrolled in the trial to further characterize the overall profile of the combination, including safety, efficacy and durability of response.
Clinical Activity Data
The poster presented at ESH is now available on the Publications and Abstracts section of the Syros website
The ongoing Phase 2 trial is actively enrolling patients with relapsed or refractory AML patients who are positive for the RARA
biomarker. Syros expects to report potential proof-of-concept from the cohort in relapsed or refractory AML patients in 2020. Additional details about the Phase 2 trial
of SY-1425 can be found using the identifier NCT02807558 at www.clinicaltrials.gov.
About Syros Pharmaceuticals
Syros is redefining the power of small molecules to control the expression of genes. Based on its unique ability to elucidate regulatory regions of the genome,
Syros aims to develop medicines that provide a profound benefit for patients with diseases that have eluded other genomics-based approaches. Currently focused on cancer and monogenic diseases, Syros is advancing a robust pipeline of development
candidates, including SY-1425, a first-in-class oral selective RAR agonist in a Phase 2 trial in a genomically defined
subset of acute myeloid leukemia patients, and SY-5609, a highly selective and potent oral CDK7 inhibitor in investigational new drug application-enabling studies in cancer. Syros also has multiple preclinical
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 promise of SY-1425 as a combination agent and the ability of SY-1425 to provide a meaningful benefit to AML patients, the reporting of potential
proof-of-concept data for SY-1425 in combination with azacitidine in relapsed or refractory AML patients in 2020, the predictive
value of the RARA biomarker, and the power of Syros gene control platform. 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-1425, under the timelines it projects; demonstrate in clinical trials the requisite safety, efficacy and combinability of
SY-1425; sustain the response rates and durability of response seen to date with SY-1425 in combination with azacitidine; successfully develop a companion diagnostic
test to identify patients with the RARA biomarker; obtain and maintain patent protection for SY-1425 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; 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
and Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, each of 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.
Syros Pharmaceuticals
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