Salt Lake City – January 7, 2025
Recursion, a clinical-stage TechBio company pioneering the integration of artificial intelligence and biotechnology, has announced the advancement of two AI-designed oncology drug candidates—REC-3565 and REC-4539—into early-stage clinical trials. These investigational therapies aim to address major unmet needs in hematologic cancers and small-cell lung cancer (SCLC), further cementing Recursion’s role as a leader in AI-driven precision medicine.
REC-3565: MALT1 Inhibitor for B-Cell Malignancies
Recursion has received regulatory clearance from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate a Phase 1 trial of REC-3565, an AI-optimized MALT1 inhibitor. This novel therapy targets chronic lymphocytic leukemia (CLL) and B-cell lymphomas, offering potential hope to over 41,000 relapsed or refractory patients annually in the US and EU5 regions.
REC-4539: First-in-Class LSD1 Inhibitor for SCLC
In parallel, the U.S. FDA has cleared the Investigational New Drug (IND) application for REC-4539, a brain-penetrant LSD1 inhibitor engineered to treat small-cell lung cancer (SCLC). Designed via Recursion’s proprietary AI platform, REC-4539 targets an estimated 45,000 patients annually across the US and EU5—many of whom face limited options for aggressive and metastatic disease.
AI-Enabled Drug Design at Scale
“The precision design enabled by our AI-powered platform is crucial for identifying and optimizing molecules with unique properties, such as REC-4539 and REC-3565,”
— Chris Gibson, Ph.D., Co-Founder and CEO, Recursion
Recursion’s integrated AI drug discovery engine leverages its Recursion OS platform to accelerate and optimize therapeutic design through large-scale data analysis, simulation, and prediction.
Strategic Focus: Brain Metastases and Refractory Disease
“REC-4539’s ability to target brain metastases and REC-3565’s unique MALT1 inhibition profile demonstrate our AI’s ability to address highly challenging cancer types with innovative therapies,”
— Najat Khan, Ph.D., Chief R&D and Commercial Officer, Recursion
These candidates are the result of advanced structure-activity modeling and phenotypic screening capabilities made possible by Recursion’s access to one of the world’s largest biological datasets and top-tier compute infrastructure.
Clinical Programs Underway in 2025
- EXCELERIZE (REC-3565): A Phase 1 trial evaluating safety and tolerability in combination with standard therapies for B-cell malignancies. First patient dosing is anticipated in Q1 2025.
- ENLYGHT (REC-4539): A Phase 1/2 trial examining REC-4539 as both monotherapy and in combination with durvalumab in SCLC and other solid tumors, with patient enrollment expected to begin in H1 2025.
About Recursion
Recursion is a clinical-stage biotechnology company industrializing drug discovery with AI. Its proprietary platform—Recursion OS—combines biology, chemistry, and patient-centric data with massive computational scale. Enabled by one of the most powerful AI supercomputers in the pharmaceutical industry (BioHive-2), Recursion is accelerating the development of innovative therapeutics across oncology and beyond.
By
