We Aim to Bring Much-Needed Medicines to Patients
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 Overexpression in MDS and AML
Tamibarotene (formerly SY-1425) is an oral, selective retinoid acid receptor alpha (RARα) agonist that we are developing in newly diagnosed patients with RARA gene overexpression with higher-risk myelodysplastic syndrome (HR-MDS) and newly diagnosed acute myeloid leukemia (AML) patients with RARA gene overexpression who are not suitable candidates for standard intensive chemotherapy.
High response rates, rapid onset of responses and clinically meaningful durability were shown in a Phase 2 study of tamibarotene in combination with azacitidine in newly diagnosed AML patients with RARA overexpression who are not suitable candidates for standard chemotherapy, including in patients with low blast count AML. Data also showed that tamibarotene in combination with azacitidine was generally well tolerated, with no increase in toxicities beyond what has been previously seen with either agent alone. Additionally, data from a translational analysis of these trial patients also suggest that patients with RARA overexpression may be less likely to respond to the current standard of care.
These data support the advancement of tamibarotene into two ongoing clinical trials: first, our Phase 3 SELECT-MDS-1 trial of tamibarotene in combination with azacitidine in newly diagnosed higher-risk MDS patients with RARA overexpression, a hematologic malignancy that is closely related to AML; and second, our randomized Phase 2 SELECT-AML-1 trial in combination with venetoclax and azacitidine in newly diagnosed unfit AML patients with RARA overexpression.
Downloadable MDS Trial Fact Sheet
Downloadable AML Trial Fact Sheet
Read more about our Phase 3 trial in HR-MDS Read more about our Phase 2 trial in AML
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.
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. Data evaluating SY-5609 in combination with chemotherapy demonstrated that the combination was well-tolerated with evidence of clinical activity, including a confirmed partial response in a pancreatic cancer patient who was unresponsive to frontline therapy. We are seeking a partnership for the further development of SY-5609.
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.
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.