Syros Pharmaceuticals (NASDAQ: SYRS) today outlined its strategic priorities and expected upcoming milestones.
"2019 was marked by significant progress across our pipeline, as Syros redefines the power of small molecules to control the expression of genes," said Nancy Simonian, M.D., Syros' Chief Executive Officer. "We shared promising clinical data for SY-1425 in newly diagnosed unfit RARA-positive AML patients, as well as exciting preclinical data for SY-5609 that speak to its potential as a best-in-class oral CDK7 inhibitor. We ended the year on a strong note, entering into a collaboration with Global Blood Therapeutics that allows us to expand and accelerate our efforts to bring an oral medicine to market that may provide a functional cure for people living with sickle cell disease or beta thalassemia."
"We are excited to build on this progress in 2020, with multiple milestones expected across our clinical and discovery-stage pipeline," Dr. Simonian continued. "We look forward to advancing SY-5609 into clinical development in the first quarter, and to reporting clinical data for both SY-1425 and SY-5609, including potential proof-of-concept data for SY-1425 in RARA-positive relapsed or refractory AML patients, in the fourth quarter. In parallel, we continue to advance our discovery pipeline in cancer and monogenic disease areas where we believe we have the potential to deliver transformative gene control medicines for diseases that have eluded other genomics-based approaches."
Expected Clinical Milestones
Report potential proof-of-concept data in fourth quarter of 2020 from ongoing Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia (AML) patients.
Report mature data in fourth quarter of 2020 from fully enrolled Phase 2 trial cohorts evaluating SY-1425 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
Initiate Phase 1 trial of SY-5609 in first quarter of 2020 in patients with breast, colorectal, lung and ovarian cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.
Report initial safety, tolerability, pharmacokinetic and pharmacodynamic data in fourth quarter of 2020 from dose escalation portion of Phase 1 trial.
Report additional dose escalation data, including clinical activity data, in mid-2021.
Syros expects to nominate its next development candidate by the end of 2021.
Syros also announced today that the Company's second monogenic disease program is in myotonic dystrophy type 1.
Based on its current operating plans, Syros expects that its existing cash, cash equivalents and marketable securities are sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2021 through key clinical milestones for both SY-1425 and SY-5609.