Schrödinger Gains Fast Track for SGR-1505 in Treating Relapsed/Refractory Waldenström Macroglobulinemia

Schrödinger, Inc., listed on Nasdaq as SDGR, recently announced the U.S. Food and Drug Administration (FDA) has granted Fast Track status to its clinical-stage drug candidate, SGR-1505. This MALT1 inhibitor is intended for adults suffering from Waldenström macroglobulinemia who have not responded to at least two previous treatments, including one with a Bruton’s tyrosine kinase (BTK) inhibitor.

Dr. Karen Akinsanya, President and Head of Therapeutics R&D at Schrödinger, highlighted the importance of this designation. She stated that the Fast Track status acknowledges the pressing need for new treatments among patients with Waldenström macroglobulinemia, a condition where current therapeutic advancements are often thwarted by resistance to BTK inhibitors, leading to treatment failure and disease progression. This challenge presents an opportunity for new mechanisms like MALT1 to be explored both as standalone therapies and as components of combination regimens.

Schrödinger’s Chief Medical Officer, Margaret Dugan, expressed optimism about SGR-1505's potential. The Fast Track designation comes in conjunction with positive Phase 1 data from trials involving various B-cell malignancies, including chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and marginal zone lymphoma. Dugan emphasized that these findings showcase SGR-1505 as a promising therapeutic option for patients, and the company anticipates further discussions with the FDA about the Phase 1 study results and the Phase 2 dosage recommendations later this year.

The FDA's Fast Track program aims to accelerate the development and review process of drugs that address serious conditions and unmet medical needs. Drugs with this designation benefit from increased interaction with the FDA, potentially facilitating expedited approval through Accelerated Approval, Priority Review, or Rolling Review, should they meet the necessary criteria.

Currently, SGR-1505 is undergoing Phase 1 clinical trials to assess its effectiveness in treating patients with relapsed or refractory B-cell malignancies. Recent presentations at major conferences, such as the European Hematology Association Annual Congress, highlighted the drug’s favorable safety profile and tolerability. Preliminary efficacy signs were particularly noted in patients with different B-cell malignancy subtypes, including those with Waldenström macroglobulinemia previously treated with BTK inhibitors.

In addition to the Fast Track status, on August 11, 2023, the FDA granted SGR-1505 orphan drug designation for Mantle Cell Lymphoma (MCL), based on promising preclinical data.

SGR-1505 represents an oral investigational approach targeting MALT1, a critical enzyme in cancer cell signaling pathways that govern survival and proliferation. This makes MALT1, located downstream of BTK in the NF-κB signaling pathway, an attractive target for developing new treatments for a range of B-cell malignancies. Preclinical studies have shown the drug to be both potent and selective, demonstrating anti-tumor activity as a monotherapy and in combination with BTK and BCL-2 inhibitors. Beyond oncology, MALT1 inhibition is being explored as a potential treatment for inflammatory and autoimmune disorders.

The development of SGR-1505 was expedited through Schrödinger’s computational platform, resulting in its discovery within ten months of initiating the MALT1 program. The ongoing Phase 1 trial (NCT05544019) continues to evaluate its efficacy in patients with relapsed or refractory B-cell malignancies.

Schrödinger, a leader in molecular discovery, leverages its computational platform to innovate and optimize molecules for drug and materials development. Founded in 1990, the company employs around 800 individuals across 15 global locations, driving advancements in collaborative and proprietary oncology programs.