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.

SY-1425 Clinical Trial Recruitment 052021 Letter
Downloadable MDS Trial Fact Sheet

Read more about our Phase 3 trial in HR-MDS

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 are currently evaluating SY-2101 in a dose confirmation study. Based on the results of the dose confirmation trial, 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 AND BLOOD CANCER

SY-5609 is a highly selective and potent oral inhibitor of the cyclin-dependent kinase 7 (CDK7) that is in development for pancreatic cancer, mantle cell lymphoma (MCL), and BRAF-mutant colorectal cancer (CRC) patients.

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 these data along with our preclinical data supporting various combination approaches, SY-5609 will be evaluated in three combination regimens.

We plan to initiate a dose expansion evaluating SY-5609 in combination with chemotherapy for the treatment of metastatic pancreatic cancer in the fourth quarter of 2021. We also plan to initiate a Phase 1b trial evaluating SY-5609 in combination with a Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of MCL in the first half of 2022. In addition, we entered into an agreement with Roche to explore SY-5609 in combination with atezolizumab in patients with BRAF-mutant CRC 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.

You can review that policy here