Recursion Reports Interim Phase 1 Clinical Data for REC-617 Monotherapy, a Potential Best-in-Class CDK7 Inhibitor, With Encouraging Patient Response and Favorable Tolerability

• REC-617, a precision designed molecule, demonstrated dose-linear pharmacokinetics (PK) with rapid absorption and robust pharmacodynamic (PD) biomarker modulation, suggesting substantial target engagement
• Confirmed partial response (PR) observed during monotherapy dose-escalation in a patient with platinum-resistant ovarian cancer, treated with 4 lines of prior therapy in advanced setting, durable response ongoing after more than 6 months of treatment
• Additional 4 patients demonstrated a best response of stable disease (SD) for up to 6 months of treatment
• Plans to continue monotherapy dose escalation and initiate combination studies in 1H 2025

SALT LAKE CITY, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX) reported initial monotherapy dose-escalation data from the Phase 1/2 study (ELUCIDATE) of REC-617, a selective CDK7 inhibitor, in advanced solid tumors.

These results were presented today after market close at an AACR Special Conference in Cancer Research. The company will also hold a webinar on December 10 at 6:30 AM MT / 8:30 AM ET / 1:30 PM GMT to present the preliminary data broadcast from Recursion’s X (formerly Twitter), LinkedIn, and YouTube accounts with an opportunity to submit questions here.

"Cell cycle dysregulation and transcriptional 'addiction' are both hallmarks of many aggressive cancers," said David Hallett, Ph.D., Chief Scientific Officer of Recursion. "By inhibiting CDK7, we have the potential to target both mechanisms while fine tuning the therapeutic index. Using our precision design platform, we created a molecule with rapid oral absorption to reduce GI tissue exposure, a suitable half life to manage side effects, and target engagement covering the IC80 level."

ELUCIDATE is an ongoing Phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) of REC-617 in patients with advanced solid tumors. As of the November 15, 2024 data cutoff, preliminary findings include 18 patients with advanced solid tumors who were response evaluable in the monotherapy dose-escalation phase. Doses ranged from 2 mg to 20 mg once daily (QD) and 1 mg twice daily (BID).

REC-617 was generally well-tolerated across all dose levels, with no discontinuations due to adverse events (AEs). Adverse events to date were predominately Grade 1-2, on-target, and reversible. An MTD has not yet been reached.