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Recursion Begins Phase 1 Trial for Groundbreaking Cancer Treatment

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Rec 3565 Malt1 Inhibitor Clinical Trial

Salt Lake City, UT – April 8, 2025 (GLOBE NEWSWIRE) – Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company, has dosed the first patient in its Phase 1 EXCELERIZE clinical trial to evaluate REC-3565, a promising treatment for relapsed or refractory B-cell lymphomas.

REC-3565 is designed to be a best-in-class MALT1 inhibitor reducing the risk of hyperbilirubinemia, a frequent side effect associated with comparable treatments. This breakthrough comes after preclinical studies indicated durable tumor regressions in both monotherapy and combination therapies with BTK inhibitors.

Najat Khan, Recursion’s Chief R&D Officer and Chief Commercial Officer, said, “Leveraging our AI-powered Recursion OS platform, we delivered a lead candidate in just 15 months. Its allosteric design enhances potency, selectivity, and safety, which could significantly lower liver toxicity risks seen in other MALT1 inhibitors. This innovation is especially crucial for patients grappling with B-cell malignancies, where treatment options remain limited.”

The EXCELERIZE trial, which is an open-label, multicenter dose-escalation study, will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of REC-3565 in two distinct parts. Part A will identify a recommended monotherapy dose, while Part B will evaluate combination treatment regimens to further inform future studies on B-cell cancers.

David Mauro, Recursion’s Chief Medical Officer, remarked, “By advancing REC-3565, we aim to improve outcomes for patients facing B-cell malignancies. This milestone underscores our commitment to patient-centric solutions fueled by AI-driven innovation.”

REC-3565 operates by targeting MALT1, a crucial protease in the NF-kB pathway responsible for malignant B-cell growth in hematological cancers. Current therapies have shown progress, but resistance is an ongoing hurdle. REC-3565 seeks to combat this resistance through its innovative mechanism.

In addition, unlike other MALT1 inhibitors, REC-3565 notably lessens UGT1A1 inhibition, thereby minimizing the risk of drug-drug interactions and liver-related adverse effects. This can potentially allow for safer dose escalation and higher target engagement, leading to improved clinical outcomes.

Each year, approximately 41,000 patients in the U.S. and EU5 diagnosed with chronic lymphocytic leukemia (CLL) and B-cell lymphomas are eligible for treatment. With such a significant patient population, REC-3565 holds the potential to revolutionize treatment approaches.

Founded in Salt Lake City, Recursion employs a unique platform, Recursion OS, which integrates diverse technologies to expand one of the world’s largest proprietary datasets in biology and chemistry. The company uses advanced machine-learning algorithms to reveal intricate relationships within this dataset, unhindered by human biases.

In a market driven by innovation, Recursion is establishing itself as a pivotal player in the drug discovery field. With a commitment to scientific advancement and patient care, the company continues to contribute to significant developments in medicine.

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