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Schrödinger Announces FDA Clearance of Investigational New Drug Application for SGR-1505, a MALT1 Inhibitor
Phase 1 Clinical Trial in Patients with Advanced B-Cell Malignancies Expected to Begin in the Second Half of 2022 NEW YORK--(BUSINESS WIRE)-- Schrödinger,
About this update from Schrodinger, Inc.
[{"type":"text","content":"\nPhase 1 Clinical Trial in Patients with Advanced B-Cell Malignancies Expected to Begin in the Second Half of 2022\n\n NEW YORK--(BUSINESS WIRE)--\nSchrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, today announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application for its MALT1 inhibitor, SGR-1505. Schrödinger expects to initiate a Phase 1 clinical trial of SGR-1505 in patients with relapsed or refractory B-cell lymphoma in the second half of 2022.\n\n“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,” stated Karen Akinsanya, Ph.D., president of R&D, therapeutics at Schrödinger. “There is a significant medical need for patients with relapsed or refractory B-cell lymphoma who have exhausted currently approved treatment options, and we look forward to initiating our Phase 1 clinical study of SGR-1505 later this year.”\n\nThe planned multi-center, dose-escalation study will be conducted in patients with relapsed or refractory B-cell malignancies to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary signals of therapeutic activity of SGR-1505 as a monotherapy. Once the recommended dose is determined, 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.\n\n“Our platform, which combines physics and machine learning, enabled us to accurately assess 8.2 billion compounds computationally and to synthesize only 78 molecules over a 10-month period of iterative “design, make, test” optimization cycles, ultimately selecting SGR-1505 as our development candidate,” said Robert Abel, Ph.D., chief computational scientist at Schrödinger. “FDA clearance of the IND for SGR-1505 marks an important milestone for our MALT1 program and underscores the impact of incorporating a digital chemistry strategy into research programs.”\n\nAbout SGR-1505\nSGR-1505 is a mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) inhibitor that was discovered using Schrödinger’s proprietary physics-based computational platform. MALT1 is a protease that is downstream ...