Qurient Completes First Dosing in Phase 2 Trial of Mocacyclib for Breast Cancer Patients

Initiating Efficacy Evaluation in Patients Resistant to CDK4/6 Inhibitors
Developing Next-Generation Therapeutic Strategies Targeting HR+/HER2- Breast Cancer

On June 2, Qurient announced that it has completed the first patient dosing in the Phase 2 part of its Phase 1/2 clinical trial of mocacyclib (Q901), a CDK7 inhibitor anticancer drug, targeting breast cancer patients.

Dongkoo Bio & Pharma corporate logo image. Dongkoo Bio & Pharma

This clinical trial is being conducted in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) breast cancer who have developed resistance after treatment with CDK4/6 inhibitors, the current standard therapy. Based on the recommended Phase 2 dose (RP2D) established in the preceding Phase 1 trial, Qurient plans to evaluate the anticancer efficacy of combining mocacyclib with fulvestrant, a selective estrogen receptor degrader (SERD).

Mocacyclib is a drug targeting CDK7, a protein that regulates CDK1, 2, 4, and 6, which are key in cell cycle control. The company expects that mocacyclib can suppress the activation of the PTEN-PI3K/AKT signaling pathway—a major resistance mechanism to CDK4/6 inhibitors—by regulating transcription, thereby offering the potential to overcome drug resistance.

According to Qurient, CDK7 inhibitors have recently attracted attention as a new therapeutic strategy in the field of breast cancer. Last year, samuraciclib, a CDK7 inhibitor developed by Carrick Therapeutics, demonstrated an objective response rate (ORR) of 55% in a clinical trial involving patients resistant to CDK4/6 inhibitors.

HR+/HER2- breast cancer is the most common subtype among all breast cancer patients. Currently, the market is dominated by CDK4/6 inhibitors such as Ibrance from Pfizer, Kisqali from Novartis, and Verzenio from Eli Lilly. Last year, the combined sales of these products reached 14.6 billion dollars.

Nam Kiyeon, CEO of Qurient, said, "The first patient dosing marks the entry into a stage where the efficacy of mocacyclib can be confirmed in the actual target patient group. We plan to provide a new treatment option for patients resistant to standard therapies and to expand the scope of application to indications such as triple-negative breast cancer through combination development with antibody-drug conjugates (ADCs) in the future."

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