Syros Pharma begins first in-human trial of oral CDK7 inhibitor

Syros Pharmaceuticals, a leading biotechnology company focused upon developing medicines for controlling and altering expression of genes, recently announced that the first patient has been dosed in the clinical trial of SY-5609, with a potent (CDK7) oral cyclin-dependent kinase 7 inhibitor.

The Phase 1 clinical trial is currently enrolling patients with advanced colorectal, breast, ovarian, and lung cancer, with solid tumors of any histology that possess Rb pathway alterations.

Kyriakos P. Papadopoulos, a clinical investigator in the trial and Co-Director of Clinical Research at START (South Texas Accelerated Research Therapeutics) was reportedly quoted saying that SY-5609 seems to be a promising new approach for treating a number of cancers, that have turned out unsuccessful with other targeted approaches. The team is looking forward to gain opportunities to accelerate the development of new treatments to improve lives of patients and come up with a strong antidote against cancer.

Papadopoulos added saying that SY-5609 has shown compelling preclinical activity in a range of cancer models, and the team is thrilled to further investigate it in this Phase 1 study.

As per sources close to the matter, SY-5609 has demonstrated significant anti-tumor activity, including complete regressions in several preclinical models of solid tumors, including colorectal, ovarian, lung and breast cancers, at doses below the MTD (maximum tolerated dose).

In preclinical studies of lung, ovarian, and breast cancers, more sustained responses were linked with the presence of Rb pathway alterations. The trial has also demonstrated anti-tumor activity in combination with fulvestrant in treatment-resistant models of estrogen receptor-positive breast cancer, along with those resistant to both cyclin-dependent kinase 4/6 inhibitor and fulvestrant.

The main objective of the dose escalation in the trial is to assess the tolerability and safety of escalating doses of SY-5609, aimed at establishing a maximum tolerated dose. Other objectives include assessments of pharmacokinetics, pharmacodynamics, anti-tumor activity, potential predictive biomarkers, including Rb pathway alterations. Multiple cohorts are planned to further evaluate the anti-tumor activity of SY-5609 as a single agent, as well as in combination with other therapies, in a future expansion of the Phase 1 trial.
 

Source Credit: https://ir.syros.com/press-releases/detail/182/syros-announces-first-patient-dosed-in-phase-1-clinical