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 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 or IRF8 biomarkers. 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 biomarker-positive AML patients. We estimate that about one-third of AML 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 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy. The trial is open to patients with or without the RARA or IRF8 biomarkers. The primary endpoint of the trial is overall response rate. The trial will also assess duration of response, safety and tolerability, and survival. We plan to add a cohort to the Phase 2 trial for RARA or IRF8 biomarker-positive patients with relapsed or refractory AML, and we expect this cohort to be open for enrollment in the third quarter of this year.
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. Data from the completed dose escalation portion of the Phase 1 study of SY-1365 in patients with advanced solid tumors demonstrated biological activity, as well as early signs of clinical activity, at tolerable doses. In preclinical studies, SY-1365 has demonstrated robust anti-tumor activity in multiple preclinical models of cancer, including ovarian and hormone receptor-positive (HR-positive) breast cancers. SY-1365 has also been shown preclinically to preferentially kill cancer cells over non-cancerous cells and lower the expression of key cancer-driving genes. The early clinical data, together with the 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 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 recurrent ovarian clear cell cancer patients; as a single agent in high-grade serous ovarian cancer patients who have relapsed after three or more prior therapies; in combination with carboplatin in high-grade serous 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.
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.