Recursion has announced that the FDA has cleared its IND application for REC-1245, a novel chemical entity discovered using its AI-driven platform, for a Phase 1/2 clinical trial in patients with biomarker-enriched solid tumors and lymphoma. The trial is expected to begin in the fourth quarter of this year.
The Phase 1/2 trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential monotherapy efficacy of REC-1245. Recursion believes that modulating RBM39 may have a therapeutic effect in certain biomarker-enriched solid tumors and lymphoma.
Targeting RBM39 for Cancer Therapy
REC-1245 is a potent and selective RBM39 degrader with a potential first-in-class profile. Preclinical data suggest that RBM39 degradation induces splicing defects that downregulate DNA Damage Response (DDR) networks and cell cycle checkpoints. Recursion identified the novel regulatory role of RBM39 associated with CDK12 using its maps of biology and first reported this relationship in early 2023.
Dr. Najat Khan, Chief R&D Officer and Chief Commercial Officer at Recursion, explained that RBM39 degraders may offer a promising therapeutic approach for patients with solid tumors, particularly those with limited treatment options. "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," she added.
Rapid Drug Development Enabled by AI
Chris Gibson, Co-founder and CEO of Recursion, noted the speed at which REC-1245 was developed. "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."
Market Opportunity
Recursion estimates that the initially addressable population for this potential therapeutic to be more than 100,000 patients in the US and EU5 countries (France, Germany, Italy, Spain, and the United Kingdom).
