Recursion Advances Trials For Tow Key Cancer Therapies Targeting Hematologic Malignancies And SCLC
Recursion secures approvals for REC-3565 and REC-4539, advancing AI-driven cancer therapy research.
Breaking News
Jan 08, 2025
Simantini Singh Deo

Recursion is a clinical-stage TechBio company focused on revolutionising drug discovery through advanced technology. It has announced two significant regulatory clearances for its pipeline cancer therapies. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a clinical trial application (CTA) for a Phase 1 trial of REC-3565, a promising MALT1 inhibitor targeting B-cell malignancies. This therapy has the potential to address approximately 41,000 relapsed and/or refractory (R/R) patients with chronic lymphocytic leukaemia (CLL) and B-cell lymphomas annually across the US and EU5 countries.
Chris Gibson, PhD, Co-Founder and CEO of Recursion, said, “We are excited to add REC-4539 and REC-3565 to our clinical-stage portfolio as we explore first- and best-in-class oncology medicines and build momentum and value through our pipeline. These are prime examples of how precision design, powered by the Recursion OS platform with advanced AI capabilities, enables us to identify and optimise molecules with unique properties.”
In addition, REC-4539 has received IND approval from the US FDA following the process of submitting an IND application. This novel LSD1 inhibitor will advance to the Phase 1/2 study to assess its potential for SCLC and other indications. The therapy could help nearly 45,000 people diagnosed with extensive-stage SCLC annually in the US and five major European countries.
Najat Khan, PhD, Chief R&D Officer and Chief Commercial Officer of Recursion, commented, “For REC-4539, we’ve developed a reversible LSD1 inhibitor that not only targets peripheral disease but is also designed to penetrate the brain, potentially addressing a critical unmet need in small-cell lung cancer. Similarly, 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. As we expand our platform in the development space, we aim to leverage multimodal data and causal AI models to advance precision medicine through optimised patient selection, ensuring the right drug for the right patient.”