Schrödinger Halts CDC7 Inhibitor Program After Patient Deaths in Phase 1 Trial

Schrödinger, a biotechnology company known for its computational drug discovery platform, has announced the discontinuation of its CDC7 inhibitor program following two patient deaths in a phase 1 clinical trial. The decision marks a significant setback for the company and raises questions about the future of CDC7 inhibition as a therapeutic approach in oncology.

Trial Termination and Safety Concerns

The phase 1 dose-escalation study was evaluating SGR-2921, Schrödinger's CDC7 inhibitor, in patients with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes. According to the company's August 14 release, two patients with AML died during the trial, with SGR-2921 considered to have contributed to the fatalities.

Dr. Margaret Dugan, Chief Medical Officer at Schrödinger, emphasized the company's commitment to patient safety, stating, "Patient safety is our first priority, and in light of two treatment-related deaths in the phase 1 dose-escalation study, we have made the decision to discontinue further development of SGR-2921."

Implications for CDC7 Inhibition Research

The termination of Schrödinger's CDC7 inhibitor program highlights the challenges faced by researchers in this field. For over two decades, biopharmaceutical companies have been investigating CDC7 inhibition as a potential cancer treatment, but progress has been limited, with no candidates advancing to late-stage clinical trials.

Schrödinger had previously touted SGR-2921 as "the most potent CDC7 inhibitor reported to date," citing its strong drug-like characteristics. The company's digital platform was credited for enabling the creation of this compound, which was believed to have a "favorable, differentiated profile with best-in-class potential."

Schrödinger's Pipeline and Future Directions

Despite this setback, Schrödinger maintains an active oncology pipeline. The company is currently advancing two other cancer drugs in clinical trials:

1. SGR-1505: A MALT1 inhibitor in phase 1 studies for relapsed/refractory B-cell lymphomas
2. SGR-3515: A Wee1/Myt1 inhibitor undergoing early-stage studies in patients with advanced solid tumors

While the discontinuation of SGR-2921 is a significant blow to Schrödinger's CDC7 inhibitor program, the company's diverse pipeline and computational drug discovery platform may provide opportunities for future success in oncology drug development.