On May 21, 2024 Qurient Co. Ltd. (KRX: 115180), a clinical-stage biotech company based in Korea, reported to have entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH), to evaluate Qurient’s proprietary CDK7 inhibitor, Q901, in combination with an antibody drug conjugate (ADC) targeting tumor-associated calcium signal transducer 2 (TROP2) with topoisomerase 1 inhibitor payload for the treatment of small cell lung cancer (SCLC) and other relapsed solid tumors (Press release, Qurient Therapeutics, MAY 21, 2024, View Source [SID1234643511]).

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Q901 is a highly selective CDK7 inhibitor under Phase 1/2 clinical development in the United States and South Korea. Qurient demonstrated Q901’s main mechanism of action as transcriptional inhibition of essential genes for tumor progression, including genes involved in DNA damage repair response, which led to strong synergy with a topoisomerase 1 inhibitor (Ref: DOI: 10.1158/1538-7445.AM2024-5712). These results are consistent with prior findings from Dr. Anish Thomas’ team at NCI, which revealed a synergistic mechanism between CDK7 inhibition and topoisomerase 1 inhibition (Ref: DOI: 10.1158/1535-7163.MCT-21-0891).

Under this CRADA, NCI and Qurient will collaborate on an NCI-sponsored Phase 1/2 clinical study of Q901 in combination with the TROP2-ADC in SCLC and other relapsed solid tumors, starting from combination dose escalation and evaluating the safety, efficacy, and potential synergy of this novel combination. This collaboration is focused on development and evaluation of this innovative therapy for patients with extensive stage SCLC.

"The collaboration between the NCI and Qurient is based on the science discovered through independent research conducted by each institution," said Kiyean Nam, Ph.D., CEO of Qurient. "We hope the new combination therapy will help patients with small cell lung cancer, where current therapeutic options are limited."

About Q901

Q901 is a highly selective covalently binding small molecule CDK7 inhibitor under Phase 1/2 clinical development. Q901 demonstrated strong tumor growth inhibition in multiple cancer models including HR+ breast cancer, pancreatic cancer, prostate cancer, ovarian cancer, and small cell lung cancer as a single agent, as well as in combination with other therapies. Q901 in combination with fulvestrant is in a clinical trial for HR+ breast cancer patients who are refractory to CDK4/6 inhibitor and estrogen therapy combination.