We Aim to Bring Much-Needed Medicines to Patients as Quickly and Efficiently as Possible

We are advancing a growing pipeline of investigational medicines with the goal of treating a range of cancers and genetic diseases that have largely eluded other targeted approaches. We currently have two investigational medicines in clinical trials, and we have designed the trials to assess the safety and efficacy of these investigational medicines as quickly and efficiently as possible to bring much-needed medicines to patients.

SY-1425 for Genomically Defined Subsets of AML and MDS Patients

SY-1425 is an oral, first-in-class selective retinoid acid receptor alpha (RARα) agonist that is in a Phase 2 clinical trial in genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Initial data from the ongoing Phase 2 trial showed that SY-1425 as a single agent improved blood counts, reduced leukemic blasts, stabilized disease and promoted cell differentiation in relapsed or refractory AML and higher-risk MDS patients who are positive for our RARA or IRF8 biomarkers. The data also showed that chronic, daily dosing of SY-1425 was generally well-tolerated in this population. These clinical data, coupled with preclinical data showing the tumor-killing activity of SY-1425 in combination with standard-of-care hypomethylating agents and targeted anti-CD38 therapies, lead us to believe that SY-1425 may have promise as a combination agent for biomarker-positive AML and MDS patients. We estimate that about one-third of AML and MDS patients have one or both of these biomarkers.

The ongoing Phase 2 clinical trial is a multi-center, open-label trial exploring safety and efficacy of SY-1425 assessing the safety and efficacy of SY-1425 in combination with a standard-of-care hypomethylating agent known as azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy, and in combination with a targeted anti-CD38 therapy known as daratumumab in relapsed or refractory AML and higher-risk MDS patients. The cohort assessing SY-1425 in combination with azacitidine is open to patients with or without the RARA or IRF8 biomarkers. All patients selected for the clinical trial cohort assessing SY-1425 in combination with daratumumab must be positive for either the RARA or IRF8 biomarker, or both. The primary endpoint of the trial is overall response rate. The trial will also assess pharmacokinetic and pharmacodynamic markers, duration of response, safety and tolerability, and survival.

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SY-1365 for Advanced Solid Tumors

SY-1365 is a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor that is in a Phase 1 clinical trial in patients with ovarian and breast cancers. SY-1365 has demonstrated robust anti-tumor activity in multiple preclinical models of cancer, including ovarian and hormone receptor-positive (HR-positive) breast cancers. In preclinical studies, SY-1365 has also been shown to preferentially kill cancer cells over non-cancerous cells and lower the expression of key cancer-driving genes. These preclinical data provide a strong rationale for further investigating the potential of SY-1365 in clinical trials.

The ongoing Phase 1 clinical trial is a multi-center, open-label trial exploring the safety and anti-tumor activity of SY-1365 in in multiple patient populations with high-grade serous ovarian and HR-positive breast cancers as a single agent and in combination with standard-of-care therapies. Specifically, the trial is evaluating SY-1365 as a single agent in primary platinum-refractory ovarian cancer patients; as a single agent in ovarian cancer patients who have relapsed after three or more prior therapies; in combination with carboplatin in ovarian cancer patients who have relapsed after one or more prior therapies; and in combination with fulvestrant in patients with HR-positive metastatic breast cancer who have progressed after treatment with a CDK4/6 inhibitor. An additional cohort is enrolling patients with any solid tumor accessible for biopsy to further evaluate SY-1365.

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Interested in Learning More about How Clinical Trials Work?

Clinical trials are an important part of helping bring safe and effective medicines to patients. For patients who lack effective treatments, clinical trials are also an opportunity to be a part of testing a new drug. By taking part in clinical trials, patients can make an important contribution to ongoing research and better understanding of a disease.

Learn more about participating in clinical trials

Access to Investigational Products Outside of a Clinical Trial

Syros has adopted a policy that describes the guidelines by which it will consider requests for access to one of its investigational products outside of a clinical trial.

You can review that policy here