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Cyclacel Enrolling Patients in Phase I/II PLK1 Inhibitor Trial

NEW YORK – Cyclacel Pharmaceuticals on Tuesday said the first patient has received treatment in a Phase I/II trial of its investigational PLK1 inhibitor CYC140.

The multicohort trial, dubbed CYC140-101, is initially enrolling patients with advanced solid tumors and lymphomas at City of Hope and MD Anderson Cancer Center. In the Phase I portion, the Berkeley Heights, New Jersey-based company will determine optimal dosing and improve understanding of the drug's safety and tolerability. In the Phase II, proof-of-concept portion of the study, Cyclacel will enroll patients in up to seven histology-specific cohorts, and one basket cohort.

The tumor-specific cohorts will include patients with lymphomas, and bladder, breast, hepatocellular and biliary tract, lung, and colorectal cancers, including patients with KRAS mutations. The basket cohort will include patients with MYC-amplified tumors and other biomarkers that can be interrogated by CYC140's mechanism of action.

If certain cohorts are responding well, the company can expand enrollment, which could expedite the drug's development and the company's registration plan for CYC140. Cyclacel expects an initial data readout from the study in the first half of 2023.

PLK1 plays a key role in cell division and has shown to drive cancer cells harboring p53 and KRAS mutations. "The totality of preclinical evidence suggests that CYC140 has significant potency and single-agent activity," Miguel Villalona-Calero, co-leader of City of Hope's development cancer therapeutics program, said in a statement. "This novel agent warrants clinical investigation across multiple solid tumors and lymphomas."

Last year, Cyclacel began a Phase I/II trial of its other CDK2/9 inhibitor, fadraciclib. There, the goal is to establish an optimal dose and explore therapeutic efficacy across different cohorts including patients with breast, colorectal, endometrial, hepatocellular, and ovarian cancers as well as certain lymphomas.

The breast cancer cohort involves patients with metastatic, hormone receptor-positive, HER2-negative breast cancer whose cancers have progressed following treatment with a CDK4/6 inhibitor as well as patients who are refractory to HER2-targeting treatment and those with triple-negative breast cancer. This study also includes a tumor-agnostic cohort of patients with MCL1- or MYC- or cyclin E-amplified cancers.