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February 9, 2022

Qurient secures FDA approval to run Phase I/II solid tumour trial

The Phase I/II clinical trial of Q901 will enrol 70 patients with advanced solid tumours.

Qurient has received clearance from the US Food and Drug Administration (FDA) to run a Phase I/II trial to investigate its oncology drug candidate Q901. 

Qurient intends to enrol up to 70 advanced solid tumour patients for the Phase I/II trial expected to start in the second quarter of this year in the US. 

Q901 is a small molecule that acts on the cyclin-dependent kinase 7 (CDK7).

Determining the dose-limiting toxicities, maximum tolerated dose, and the recommended Phase II dose of Q901 will be the goal of the trial. 

Qurient CEO Kiyean Nam said: “IND clearance for Q901 is an important step forward in developing this novel drug candidate that may provide a new alternative treatment to patients with relapsed or refractory malignancies. 

“We look forward to initiating the clinical study for Q901 and presenting additional nonclinical efficacy data of Q901 in various cancer models at an upcoming scientific meeting.”

In in vitro studies, Q901 demonstrated to only hinder CDK7 in the human kinome. 

Furthermore, data from preclinical studies showed that selectively hindering CDK7 precisely destroys cancer cells with abnormal cell division cycle or transcriptional regulation.

Q901’s selective hindering of CDK7 was found to obstruct the growth of tumour in various murine cell-derived and patient-derived xenograft models, including breast, ovarian, prostate, pancreatic, small-cell lung, and colorectal cancers, according to nonclinical pharmacology studies. 

Leveraging virtual research and development (R&D) project management platform, Qurient develops new therapies from discovery to the human proof of concept stage. 

Apart from Q901, the company’s pipeline has three programmes namely Q301, Telacebec (Q203) and Q702 being analysed in clinical trials.

A topical inhibitor of leukotriene for atopic dermatitis, Q301 concluded Phase IIb trial while Q702 is being studied in Phase I/II trial.

Furthermore, Telacebec is an orally available inhibitor of cytochrome bc1 for tuberculosis and concluded Phase II trial.

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