Salt Lake City – December 9, 2024
Recursion (Nasdaq: RXRX), a leader in AI-powered drug discovery, has released interim results from its Phase 1/2 ELUCIDATE trial of REC-617, an innovative CDK7 inhibitor for advanced solid tumors, including platinum-resistant ovarian cancer. The trial demonstrates compelling efficacy and a favorable safety profile, signaling the potential of REC-617 as a best-in-class treatment for resistant cancers.
Phase 1/2 ELUCIDATE Trial: Early Successes
Preliminary findings from the ELUCIDATE trial (as of November 15, 2024) include 19 enrolled patients, of which 18 were evaluable for response. The dose-escalation phase, involving doses ranging from 2 mg to 20 mg daily, showed promising signs of REC-617’s potential:
- One platinum-resistant ovarian cancer patient—who had failed four prior therapies—achieved a 34% reduction in tumor size and a confirmed partial response (PR), lasting over 6 months.
- Additionally, four other patients showed stable disease (SD) for up to six months.
Safety and Tolerability: An Encouraging Profile
REC-617 exhibited no dose-limiting toxicities (DLTs) or treatment discontinuations due to adverse events (AEs). Reported side effects were Grade 1-2 and reversible, indicating high tolerability. Notably, the maximum tolerated dose (MTD) has not been reached, allowing continued dose escalation. Three serious adverse events (SAEs) were reported but resolved with dose adjustments, confirming REC-617’s manageable safety profile.
Pharmacokinetic & Pharmacodynamic Insights
- Dose-linear pharmacokinetics demonstrated rapid absorption (Tmax: 0.5–2 hours) and a half-life of 5–6 hours, providing a controlled dosing window.
- Target engagement was confirmed through POLR2A biomarker modulation, achieving 80-90% target engagement.
AI-Powered Design for Targeting Cancer Mechanisms
Developed using Recursion OS, REC-617 was precisely designed to inhibit CDK7, a key regulator of the cell cycle and transcription, offering therapeutic potential for aggressive cancers like ovarian cancer. Unlike traditional CDK4/6 inhibitors, REC-617 addresses transcriptional addiction and aberrant kinome activation, enhancing its efficacy in resistant cancers.
Next Steps: Exploring Combination Therapy
Recursion plans to continue dose escalation in monotherapy and begin combination therapy studies in the first half of 2025. The combination phase will explore synergy with other targeted therapies, immunotherapies, or chemotherapy regimens to improve patient outcomes.
Expert Insights on CDK7 Inhibition
“Cell cycle dysregulation and transcriptional addiction are hallmarks of many aggressive cancers. By inhibiting CDK7, we can target both mechanisms simultaneously, offering a unique therapeutic approach.”
— Dr. David Hallett, Chief Scientific Officer, Recursion
“REC-617’s AI-driven design maximizes the therapeutic index, enabling us to provide safer and more effective treatment options for patients.”
— Dr. Najat Khan, Chief R&D Officer, Recursion
About REC-617 and the ELUCIDATE Trial
REC-617 is a precision-designed CDK7 inhibitor targeting key oncogenic processes like transcriptional addiction and aberrant kinome activation. It was developed using AI-powered techniques, with only 136 novel molecules synthesized in under 12 months. ELUCIDATE is a multicenter, open-label trial designed to assess the safety, pharmacokinetics, pharmacodynamics, and efficacy of REC-617 in solid tumors including ovarian, breast, and non-small cell lung cancers (NSCLC).
About Recursion
Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company using AI to decode biology and radically improve drug discovery. Its Recursion OS platform generates one of the largest proprietary datasets in the field, enabling high-scale experiments and AI-driven insights to accelerate therapeutic development across oncology and other disease areas.
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