Schrödinger's Initial-Stage Cancer Study Gains FDA Clearance

Schrödinger Inc. SDGR announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for the drug candidate SGR-1505 in patients with relapsed or refractory B-cell lymphoma.

The Phase 1 clinical study will evaluate the safety, pharmacokinetics, pharmacodynamics of SGR-1505 in patients with relapsed or refractory B-cell lymphoma.

Karen Akinsanya, Ph.D., president of R&D, commented : “Based on the preclinical data for SGR-1505, we believe we have an opportunity to advance a potential best-in-class MALT1 inhibitor into the clinic, There is a significant medical need for patients with relapsed or refractory B-cell lymphoma who have exhausted currently approved treatment options.

The company is planning to initiate Phase 1 clinical study of SGR-1505 in the second half of 2022.

Further, an expansion cohort is planned to evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.

Shares of Schrödinger are trading down 1 percent at $28.71