Recursion Announces Two Key Investigational Oncology Drugs Advancing to Clinical Trials, Targeting High Unmet Needs in Hematologic Malignancies, Small-Cell Lung Cancer, & More

Clinical Trial Approvals - The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has cleared a clinical trial application (CTA) for a Phase 1 clinical trial of REC-3565, a potential best-in-class MALT1 inhibitor for B-cell malignancies [1] - The U S Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase 1/2 clinical trial of REC-4539, a potential best-in-class LSD1 inhibitor for small-cell lung cancer (SCLC) and other potential indications [1] Target Populations - The total addressable population for REC-3565 includes approximately 41,000 relapsed and/or refractory (R/R) patients with chronic lymphocytic leukemia (CLL) and B-cell lymphomas in the US+EU5 annually [1][2] - The total addressable population for REC-4539 in the US+EU5 for extensive stage SCLC is approximately 45,000 patients annually [1][8] Mechanism of Action - REC-3565 is a highly selective MALT1 inhibitor without significant off-target inhibition of UGT1A1, which could enhance combination therapy by mitigating potential risks of drug-drug interaction and hyperbilirubinaemia [1][4] - REC-4539 is a reversible LSD1 inhibitor designed to penetrate the brain, potentially addressing a critical unmet need in small-cell lung cancer [1][6] Preclinical Data - REC-3565 has shown tumor growth inhibition in a range of hematological xenograft models as both a single agent and in combination with BTK inhibitors, with durable tumor eradication observed in combination with zanubrutinib in an ABC-DLBCL xenograft model [5] - REC-4539 has demonstrated dose-dependent tumor inhibition in an SCLC xenograft model with brain penetration and a reversible mechanism [13] Clinical Trial Timelines - The first patient is expected to be dosed in the Phase 1 EXCELERIZE clinical trial for REC-3565 in Q1 2025 [7] - The first patient is expected to be dosed in the Phase 1/2 ENLYGHT clinical trial for REC-4539 in H1 2025 [9] Company Overview - Recursion is a clinical stage TechBio company leveraging the Recursion OS platform, which integrates advanced AI capabilities to identify and optimize molecules with unique properties [1][10] - The company is headquartered in Salt Lake City and has offices in Toronto, Montréal, London, and the San Francisco Bay Area [11]