Recursion's REC-1245 Receives FDA Clearance for Phase 1/2 Cancer Trial
Key Insights
Recursion's REC-1245, a novel chemical entity, has been cleared by the FDA for a Phase 1/2 clinical trial targeting solid tumors (search) and lymphoma (search).
The trial, set to begin in Q4 2024, will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential efficacy of REC-1245 as a monotherapy.
REC-1245 targets RBM39 (search), a regulator associated with CDK12 (search), and preclinical data suggests it could disrupt DNA Damage Response networks and cell cycle checkpoints.
Recursion Pharmaceuticals' REC-1245, a potential first-in-class RBM39 (search) degrader, has received FDA clearance for a Phase 1/2 clinical trial, marking a significant step in the development of novel cancer therapies. The trial aims to evaluate REC-1245 as a treatment for biomarker-enriched solid tumors (search) and lymphoma (search), with dosing scheduled to begin in Q4 2024.
Targeting RBM39 for Cancer Therapy
REC-1245 is designed to target RBM39 (search), a regulator associated with CDK12 (search). Preclinical data suggest that RBM39 degradation could disrupt DNA Damage Response (DDR) networks and cell cycle checkpoints, offering a new approach for treating solid tumors (search), especially those resistant to existing therapies. This mechanism provides new opportunities for targeting tumors, which are often resistant to conventional treatments.
According to Dr. Chris Gibson, Co-founder and CEO of Recursion, REC-1245 progressed from target identification to a preclinical drug candidate in under 18 months. This rapid development is attributed to the company's AI-enabled active learning modules, which are designed to industrialize drug discovery by decoding biology through a combination of experimental and computational approaches.
Clinical Trial Details and Potential Impact
The Phase 1/2 clinical trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential monotherapy efficacy of REC-1245. Recursion estimates that the initially addressable population for this potential therapeutic to be more than 100,000 patients in the US and EU5.
Dr. Najat Khan, Chief R&D Officer and Chief Commercial Officer at Recursion, stated that independent research has validated the therapeutic potential of RBM39 (search) degradation. By advancing this research, the company aims to deliver a critical option for patients facing significant unmet needs, ultimately improving their prognosis and quality of life.
Recursion's AI-Driven Drug Discovery
Recursion operates on the Recursion OS platform, which leverages machine learning to analyze a vast proprietary dataset of biological and chemical relationships. This platform allows for the rapid identification and optimization of small molecules that target RBM39 (search) without directly impacting CDK12 (search) or CDK13.
Financial and Strategic Context
As Recursion prepares to launch its Phase 1/2 clinical trial for REC-1245, investors should consider some key financial metrics and insights. The company's market capitalization stands at $1.73 billion, reflecting investor expectations for its innovative AI-driven drug discovery platform. Recursion's revenue for the last twelve months as of Q2 2023 was $49.63 million, with a quarterly revenue growth of 30.86% in Q2 2023. However, it's important to note that Recursion is currently operating at a loss, with an adjusted operating income of -$396.42 million for the last twelve months. The company holds more cash than debt on its balance sheet, providing some financial flexibility as it moves forward with its clinical programs.