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Syros Data from Clinical Trial of SY-1425 in Genomically Defined AML and MDS Patients Support the Potential Clinical Utility of the Biomarker Test for Patient Selection.

M2 PHARMA-October 6, 2017-Syros Data from Clinical Trial of SY-1425 in Genomically Defined AML and MDS Patients Support the Potential Clinical Utility of the Biomarker Test for Patient Selection

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- Biomarker status of patients screened for Cambridge, Massachusetts-based gene control medicines specialist Syros Pharmaceuticals' (NASDAQ: SYRS) ongoing Phase 2 clinical trial of SY-1425 in genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) was predictive of myeloid cell differentiation in the patients' blood samples treated ex vivo with SY-1425, the company said.

SY-1425 is the company's first-in-class selective retinoic acid receptor alpha agonist. The biomarker test being used to screen patients for the clinical trial is a qPCR-based clinical assay measuring RARA and IRF8 mRNA expression with a turnaround time of less than three days on average.

RARA and IRF8mRNA serve as biomarkers for super-enhancers, which are highly specialized regulatory regions of DNA, associated with the RARA and IRF8 genes.

Syros discovered these super-enhancers in subsets of AML and MDS patients and showed in preclinical studies that the super-enhancers were predictive of response to SY-1425.

The data demonstrate that approximately 40% of 201 evaluable patients screened for the clinical trial through August were biomarker-positive, including approximately one-third of relapsed or refractory AML and higher-risk MDS patients tested.

Additionally, induction of myeloid cell differentiation following ex vivo treatment of patient blood samples with SY-1425 was significantly correlated with a positive biomarker test result. Importantly, this finding supports the potential clinical utility of the biomarker test for patient selection.

SY-1425 robustly induced CD38, a differentiation marker, in an in vivo model of biomarker-positive AML.

By contrast, there was minimal or no CD38 expression induced in the same in vivo model of biomarker-positive AML treated with ATRA, a non-selective retoinic acid receptor agonist, and an untreated control, respectively.

The Phase 2 clinical trial is assessing the safety and efficacy of SY-1425 as a monotherapy and in combination with azacitidine in AML and MDS patient populations. All patients enrolled in the trial are prospectively selected using the RARAand IRF8 biomarkers.

Syros Pharmaceuticals is researching use of the non-coding region of the genome to discover medicines that control expression of disease-driving genes.

The company's proprietary gene control platform has broad potential to create medicines 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.

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Publication:M2 Pharma
Date:Oct 6, 2017
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