Our Vision for SY-5609 is to be a Transformative Targeted Approach for Difficult-to-Treat Cancers
SY-5609 is a highly selective and potent oral inhibitor of the cyclin-dependent kinase 7 (CDK7) in development for select solid tumors. We have initiated the safety lead-in portion of the SY-5609 trial in combination with chemotherapy in pancreatic cancer patients. SY-5609 is also being evaluated in combination with atezolizumab, a PD-L1 inhibitor, in BRAF-mutant colorectal cancer in Roche’s Phase 1/1b INTRINSIC trial.
SY-5609 represents a novel targeted approach that we believe has potential in a range of difficult-to-treat cancers. Data from a dose-escalation study demonstrated single-agent activity, including prolonged stable disease, tumor shrinkage, and tumor marker decreases, across multiple tumor types. Notably, the prolonged stable disease and tumor shrinkage observed in metastatic pancreatic cancer patients is distinct from what one would expect to see in this highly refractory patient population.
Based on these clinical data, along with preclinical data and mechanistic rationale, which support the potential of CDK7 inhibition in solid tumors, we believe SY-5609 has the opportunity to provide a profound benefit for patients with cancers that have largely eluded treatment to date.