On June 27, 2025 Schrödinger, Inc. (Nasdaq: SDGR) reported that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor (Press release, Schrodinger, JUN 27, 2025, View Source [SID1234654163]).

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"We are excited to receive Fast Track designation for SGR-1505, which underscores the significant need in patients with Waldenström macroglobulinemia," said Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships at Schrödinger. "Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients. This unmet need represents an opportunity for novel mechanisms such as MALT1 as monotherapy and as part of new combination regimens."

"We believe this Fast Track designation in Waldenström macroglobulinemia, combined with our encouraging Phase 1 data across a broad range of relapsed/refractory B-cell malignancies such as chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and marginal zone lymphoma, reinforce the potential of SGR-1505 as a future therapeutic option for patients," said Margaret Dugan, chief medical officer at Schrödinger. "We look forward to discussing our Phase 1 study results and recommended Phase 2 dose with the FDA later this year."

The FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. A drug granted Fast Track designation is eligible for multiple benefits, including more frequent meetings and written communications with the FDA, as well as eligibility for Accelerated Approval, Priority Review or Rolling Review, if relevant criteria are met.

SGR-1505 is currently being evaluated in a Phase 1 clinical study as a treatment for patients with relapsed/refractory B-cell malignancies. Initial data were recently presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and International Conference on Malignant Lymphoma where SGR-1505 was observed to have a favorable safety profile and was well tolerated. Encouraging signs of preliminary efficacy were observed in multiple B-cell malignancy subtypes, including Waldenström macroglobulinemia patients, previously treated with a BTK inhibitor prior to starting SGR-1505.

On August 11, 2023, the FDA granted orphan drug designation to SGR-1505 for Mantle Cell Lymphoma (MCL) based on preclinical data.

About SGR-1505
SGR-1505 is an oral investigational MALT1 inhibitor being evaluated for the treatment of relapsed/refractory B-cell malignancies. MALT1 plays a central role in key signaling pathways that drive cancer cell survival and proliferation, making its location downstream of BTK in the NF-κB signaling pathway an attractive target for the development of novel therapeutics for a potentially broad range of B-cell malignancies. In preclinical studies, SGR-1505 was observed to be highly potent and selective, and has demonstrated anti-tumor activity in preclinical models both as a monotherapy and in combination with BTK and BCL-2 inhibitors. There is also emerging therapeutic rationale supporting MALT1 inhibition as a potential treatment for inflammatory and autoimmune disorders.

SGR-1505 was designed using Schrödinger’s computational platform at scale and was discovered approximately 10 months after the company started its MALT1 program. A Phase 1 study in patients with relapsed/refractory B-cell malignancies is ongoing (NCT05544019).