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.
SY-1425 for Genomically Defined Subsets of AML Patients
SY-1425 is an oral, first-in-class selective retinoid acid receptor alpha (RARα) agonist that is currently in a Phase 2 clinical trial in combination with a standard-of-care therapy known as azacitidine in patients with acute myeloid leukemia (AML).
Initial data from the ongoing Phase 2 trial showed that SY-1425 in combination with azacitidine had high response rates and rapid onset of responses in AML patients who are positive for our RARA biomarker. The initial data also showed that SY-1425 in combination with azacitidine was generally well-tolerated with no increase in toxicities beyond what has been previously seen with either agent alone. These initial clinical data, coupled with preclinical data showing the tumor-killing activity of SY-1425 in combination with azacitidine, lead us to believe that SY-1425 may have broad potential as a combination agent for RARA-positive AML patients. We estimate that about 30 percent of AML patients are RARA-positive.
The ongoing Phase 2 clinical trial is a multi-center, open-label trial exploring safety and efficacy of SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory AML patients. The trial is also following patients from a fully enrolled cohort of newly diagnosed AML patients who are not suitable candidates for standard chemotherapy to assess its safety and efficacy in those patients. The primary endpoint of the trial is overall response rate. The trial will also assess duration of response, safety and tolerability, and survival.
SY-5609 FOR PATIENTS WITH SELECT SOLID TUMORS
SY-5609 is a highly selective and potent oral inhibitor of the cyclin-dependent kinase 7 (CDK7) in a Phase 1 trial in patients with advanced breast, colorectal, lung or ovarian cancer, or with solid tumors of any histology that harbor Rb pathway alterations.
SY-5609 has shown robust anti-tumor activity, including complete regressions, in preclinical models of breast, colorectal, lung and ovarian cancers at doses below the maximum tolerated dose. In preclinical studies of breast, lung and ovarian cancers, deeper and more sustained responses were associated with the presence of Rb pathway alterations. SY-5609 has also shown substantial anti-tumor activity in combination with fulvestrant in treatment-resistant models of estrogen receptor-positive breast cancer, including those resistant to both fulvestrant and a CDK4/6 inhibitor.
The Phase 1 trial is a multi-center, open-label, dose-escalation trial in patients with advanced breast, colorectal, lung or ovarian cancer, or with solid tumors of any histology that harbor Rb pathway alterations. The primary objectives of trial are to assess the safety and tolerability of escalating doses of SY-5609, with the goal of establishing a maximum tolerated dose. Additional objectives include assessments of anti-tumor activity, pharmacokinetics, pharmacodynamics and potential predictive biomarkers, including Rb pathway alterations.
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.
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.