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 three investigational medicines in clinical development. We currently have two investigational medicines in clinical trials.
SY-1425 for RARA-positive MDS and AML
SY-1425 is an oral, first-in-class selective retinoid acid receptor alpha (RARα) agonist that we are developing in newly diagnosed RARA-positive patients with higher-risk myelodysplastic syndrome (HR-MDS) and newly diagnosed RARA-positive acute myeloid leukemia (AML) patients who are not suitable candidates for standard intensive chemotherapy.
Clinical data to date have shown that SY-1425 in combination with azacitidine has high response rates, rapid onset of responses, and clinically meaningful duration of responses in RARA-positive newly diagnosed unfit AML patients. The combination has been generally well-tolerated with no increase in toxicities beyond what has been previously seen with either agent alone. New translational data also suggest that SY-1425 may be a promising option for newly diagnosed unfit patients who currently do not respond to standard of care.
Based on these data, we plan to initiate a Phase 3 clinical trial of SY-1425 in combination with azactidine in newly diagnosed RARA-positive HR-MDS patients in the first quarter of 2021 and a Phase 2 trial of SY-1425 in combination with venetoclax and azacitidine in newly diagnosed RARA-positive unfit AML patients in the second half of 2021.
SY-2101 FOR PATIENTS WITH APL
SY-2101 is a novel oral form of arsenic trioxide that we are developing for acute promyelocytic leukemia (APL), a subtype of AML that is caused by a fusion of the RARA and PML genes. We plan to initiate a dose confirmation study for SY-2101 in the second half of 2021. Following the dose confirmation, we expect to move into a Phase 3 clinical trial in newly diagnosed APL patients in 2022.
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 dose-escalation study in patients with advanced breast, colorectal, lung, ovarian or pancreatic 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. Early data from the ongoing Phase 1 dose-escalation study demonstrated biological activity at tolerable doses.
The Phase 1 trial is a multi-center, open-label, dose-escalation trial in patients with advanced breast, colorectal, lung, ovarian or pancreatic cancer, or with solid tumors of any histology that harbor Rb pathway alterations. The primary objectives of the trial are to assess the safety and tolerability of escalating doses of SY-5609. 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.