Recursion Obtains FDA Approval For AI-Discovered Cancer Treatment Clinical Trial

KUALA LUMPUR, Oct 3 (Bernama) -- Recursion announced the United States (US) Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase 1/2 clinical trial of REC-1245, a new chemical entity for the treatment of biomarker-enriched solid tumours and lymphoma.

According to Recursion in a statement, the Phase 1/2 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential monotherapy efficacy of REC-1245, and is expected to initiate in the fourth quarter of this year.

Its Co-founder and Chief Executive Officer, Chris Gibson said: "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.”

Recursion identified the novel regulatory role of RBM39 associated with CDK12 using its maps of biology and first reported this relationship in early 2023 during Recursion’s research and development (R&D) and investor event, Download Day.

The company believes the modulation of RBM39 may be associated with a therapeutic effect in certain biomarker-enriched solid tumours and lymphoma.

Meanwhile, its Chief R&D Officer and Chief Commercial Officer, Dr Najat Khan explained that RBM39 degraders may offer a promising therapeutic approach for patients with solid tumours, particularly those with limited treatment options.

“This mechanism provides new opportunities for targeting tumours, 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.

Additionally, Recursion estimates that the initially addressable population for this potential therapeutic to be more than 100,000 patients in the US and European Union Five (EU5), collectively, France, Germany, Italy, Spain, and the United Kingdom.

REC-1245 is a potent and selective RBM39 degrader with a potential first-in-class profile. Preclinical data support that RBM39 degradation induces splicing defects that downregulate DNA Damage Response (DDR) networks and cell cycle checkpoints.

-- BERNAMA