FDA Clears Recursion’s REC-1245 For Solid Tumor and Lymphoma Treatment Trials

Recursion, one of the leading TechBio companies in the clinical stage focused on transforming biology to enhance drug discovery, has announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for a Phase 1/2 clinical trial of REC-1245. This new chemical entity is specially designed for the treatment of solid tumors enriched with biomarkers and lymphoma.

Recursion has been able to recognize a novel regulatory function of RBM39 which is directly related to CDK12 through its biological mapping, initially presenting this finding during Download Day, the company's R&D and investor event, in early 2023.  The company believes that targeting RBM39 may offer therapeutic benefits for specific biomarker-enriched solid tumors and lymphomas. Furthermore, Recursion projects that the potential patient population for this treatment exceeds 100,000 individuals in the US and EU5. 

REC-1245 is a highly selective RBM39 degrader with a promising first-in-class profile. Preclinical evidence indicates that degrading RBM39 causes splicing defects, leading to the downregulation of DNA Damage Response (DDR) pathways and disrupting cell cycle checkpoints. Expected to commence in the fourth quarter of 2024, the Phase 1/2 study will explore REC-1245’s safety profile, tolerability, pharmacokinetics, pharmacodynamics, and its efficacy as a potential monotherapy.

Chris Gibson, Ph.D., Co-founder and CEO of Recursion, said in a statement, “REC-1245 is a prime example of using an expansive AI-enabled platform for drug discovery. After exploring many predicted biological and chemical relationships across our maps of biology, we identified RMB39 as a novel target that looks functionally similar to the well-known but hard to drug target CDK12. We also identified and optimized small molecules that target RBM39 without directly impacting CDK12 or CDK13 using these same AI-enabled maps. In under 18 months, leveraging some of our newer chemistry tools, Recursion rapidly progressed REC-1245 from novel target biology to preclinical drug candidate, more than twice the speed of industry average.”

Najat Khan, Ph.D., Chief R&D Officer and Chief Commercial Officer at Recursion, also stated “RBM39 degraders may offer a promising therapeutic approach for patients with solid tumors, particularly those with limited treatment options. Recursion’s platform was among the first to rapidly uncover the therapeutic potential of RBM39 degradation, a finding now validated by independent research. 

He further added, “This mechanism provides new opportunities for targeting tumors, which are often resistant to conventional treatments. By advancing this research, we aim to deliver a critical option for patients facing significant unmet needs, ultimately improving their prognosis and quality of life.”