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.
Tamibarotene for RARA-positive MDS and AML
Tamibarotene (formerly 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 tamibarotene 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 tamibarotene may be a promising option for newly diagnosed unfit patients who currently do not respond to standard of care.
Based on these data, we are currently studying tamibarotene in combination with azacitidine in our SELECT-MDS-1 (Phase 3) clinical trial in newly diagnosed RARA-positive HR-MDS patientsas well as in our SELECT-AML-1 (randomized Phase 2 trial) in combination with venetoclax and azacitidine in RARA-positive newly diagnosed unfit AML patients.
Downloadable MDS Trial Fact Sheet
Downloadable AML Trial Fact Sheet
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. The Phase 3 trial of SY-2101 is expected to initiate in the second half of 2023.
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) that is in development for pancreatic cancer and BRAF-mutant colorectal cancer (CRC).
Data from a dose-escalation study demonstrated single-agent activity, including prolonged stable disease, tumor shrinkage, and tumor marker decreases, across multiple tumor types. Based on mechanistic rationale, preclinical and clinical data, which support the potential of CDK7 inhibition in solid tumors, SY-5609 will be evaluated across combination regimens.
We are evaluating SY-5609 in combination with chemotherapy in pancreatic cancer patients and in combination with atezolizumab, a PD-L1 inhibitor, in BRAF-mutant colorectal cancer in Roche’s ongoing Phase 1/1b INTRINSIC trial.
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.