Syros Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of SY-5609, its Highly Selective and Potent Oral CDK7 Inhibitor, in Patients with Select Solid Tumors
January 28, 2020 at 08:31 am EST
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Syros Pharmaceuticals, Inc. announced that the first patient has been dosed in the Phase 1 clinical trial of SY-5609, its highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor. The trial is enrolling patients with advanced breast, colorectal, lung or ovarian cancer, or with solid tumors of any histology that harbor Rb pathway alterations. SY-5609 has shown substantial anti-tumor activity, including complete regressions, in multiple preclinical models of solid tumors, including breast, colorectal, lung and ovarian cancers, at doses below the maximum tolerated dose (MTD). 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 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. The Phase 1 trial is a multi-center, open-label, dose-escalation trial that is expected to enroll approximately 60 patients with advanced breast, colorectal, lung or ovarian cancer, or with solid tumors of any histology that harbor Rb pathway alterations. The primary objectives of the dose escalation are to assess the safety and tolerability of escalating doses of SY-5609, with the goal of establishing an MTD. Additional objectives include assessments of anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD) and potential predictive biomarkers, including Rb pathway alterations. In a future expansion portion of the Phase 1 trial, multiple cohorts are planned to further evaluate the safety and anti-tumor activity of SY-5609 as both a single agent and in combination with other therapies. Syros expects to report initial safety, tolerability and PK/PD data in the fourth quarter of 2020 and additional dose-escalation data, including clinical activity, in mid-2021.
Syros Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on developing new standards of care for the frontline treatment of patients with hematologic malignancies. The Company is advancing Tamibarotene, a selective retinoic acid receptor alpha (RARα), agonist for which the Company is conducting SELECT-MDS-1, a Phase III clinical trial evaluating tamibarotene in combination with azacitidine in a genomically defined subset of patients with higher-risk myelodysplastic syndrome (HR-MDS), and for which it is conducting SELECT-AML-1, a randomized Phase II clinical trial evaluating tamibarotene in combination with venetoclax and azacitidine in a genomically defined subset of newly diagnosed patients with acute myeloid leukemia (AML). Its other assets include SY-2101 and SY-5609. The Company is seeking out-licensing opportunities for the further development of SY-5609, its highly selective and potent inhibitor of cyclin dependent kinase 7 (CDK7).
Syros Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of SY-5609, its Highly Selective and Potent Oral CDK7 Inhibitor, in Patients with Select Solid Tumors