Recursion Pharmaceuticals has dosed the first patient in a Phase 1 clinical trial, EXCELERIZE, for REC-3565, a potential best-in-class MALT1 inhibitor designed to treat relapsed or refractory B-cell lymphomas. The company developed the drug candidate in just 15 months using its AI-powered Recursion OS platform. Preclinical studies indicate REC-3565 demonstrates durable tumor regressions, both alone and combined with a BTK inhibitor.
This development is potentially important for patients with B-cell malignancies who currently have limited effective treatment options, particularly those who have developed resistance to existing therapies like BTK inhibitors. REC-3565’s unique design aims to minimize a common side effect, hyperbilirubinemia (liver toxicity), observed with other MALT1 inhibitors, which could improve the drug’s safety profile and potentially allow for higher, more effective doses. This advancement underscores the growing role of AI in accelerating drug discovery and tailoring treatments to address specific challenges in cancer therapy.
The EXCELERIZE trial is a multicenter, open-label, dose-escalation study. The initial phase will determine the optimal dose of REC-3565 as a monotherapy. The subsequent phase will evaluate its efficacy in combination with other treatments for B-cell cancers, paving the way for future studies. REC-3565 targets MALT1, a key enzyme in the NF-kB pathway, known to drive the proliferation of malignant B-cells. By inhibiting MALT1, REC-3565 aims to overcome resistance to current treatments and improve patient outcomes.
The commencement of this Phase 1 trial is a significant step for Recursion. Positive results could validate the company’s AI-driven drug discovery platform and potentially position REC-3565 as a leading treatment option for B-cell lymphoma patients, addressing a significant unmet medical need. Further, success with REC-3565 could lead to broader applications of this approach in developing targeted therapies for other cancers and diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
