Qurient Therapeutics Partners with National Cancer Institute for Q901 Phase 1/2 Study with TROP2-ADC

SEONGNAM-SI, South Korea--Qurient Co. Ltd. (KRX: 115180), a clinical-stage biotech company headquartered in South Korea, has announced a new Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), a part of the National Institutes of Health (NIH). This partnership aims to investigate the potential of Qurient’s proprietary CDK7 inhibitor, Q901, when combined with an antibody drug conjugate (ADC) directed at tumor-associated calcium signal transducer 2 (TROP2), which utilizes a topoisomerase 1 inhibitor payload. The focus of this study will be on treating small cell lung cancer (SCLC) and other solid tumors that have relapsed.

Q901 is currently in Phase 1/2 clinical trials in both the United States and South Korea. It acts as a highly selective inhibitor of CDK7, targeting the transcription of crucial genes necessary for tumor progression, including those involved in the DNA damage repair response. This mechanism has shown robust synergy with topoisomerase 1 inhibitors, as demonstrated by Qurient (Ref: DOI: 10.1158/1538-7445.AM2024-5712). These findings align with previous research conducted by Dr. Anish Thomas’ team at the NCI, which also identified a synergistic interaction between CDK7 inhibition and topoisomerase 1 inhibition (Ref: DOI: 10.1158/1535-7163.MCT-21-0891).

The CRADA will facilitate a collaborative effort between the NCI and Qurient to conduct an NCI-sponsored Phase 1/2 clinical study. This study will explore the combination of Q901 with the TROP2-ADC in patients with SCLC and other solid tumors that have relapsed. The research will begin with dose escalation investigations and will assess the safety, efficacy, and potential synergistic effects of this innovative therapy. The primary goal of this collaboration is to develop and evaluate new therapeutic options for patients with extensive-stage SCLC, a group for whom current treatment options are limited.

Kiyean Nam, Ph.D., CEO of Qurient, commented on the agreement, stating, "The collaboration between the NCI and Qurient is founded on the scientific discoveries made independently by each institution. We aim for this new combination therapy to provide significant benefits to patients suffering from small cell lung cancer, where existing therapies are inadequate."

About Q901:
Q901 is characterized as a covalently binding small molecule that selectively inhibits CDK7. It is currently undergoing Phase 1/2 clinical trials. The compound has demonstrated substantial inhibition of tumor growth across various cancer models, including hormone receptor-positive (HR+) breast cancer, pancreatic cancer, prostate cancer, ovarian cancer, and small cell lung cancer, both as a monotherapy and in combination with other treatments. Notably, Q901 is also under clinical investigation in combination with fulvestrant for the treatment of HR+ breast cancer patients who have not responded to the combination of CDK4/6 inhibitors and estrogen therapy.

About Qurient:
Qurient is a clinical-stage biopharmaceutical company based in South Korea, listed on the Korea Exchange (KRX 115180). The company is dedicated to developing novel therapeutics, managing projects through a virtual R&D platform from discovery phases to human proof-of-concept stages.

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