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- CYC140, a Potent and Selective PLK1 Inhibitor to Be Evaluated as a Single Agent Across Multiple Solid Tumor and Lymphoma Types in Streamlined, Registration-Directed Study -
BERKELEY HEIGHTS, N.J., April 19, 2022 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC, NASDAQ:CYCCP, ", Cyclacel", or the ", Company", ))), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced dosing of the first patient in the Company’s streamlined, multi-cohort Phase 1/2 study of oral CYC140 in patients with advanced solid tumors and lymphomas.
“With the start of this trial, Cyclacel is now enrolling patients across three registration-directed studies to evaluate safety and efficacy of our two lead drug candidates, fadraciclib and CYC140, for the treatment of various solid tumors, lymphomas and leukemias,” said Spiro Rombotis, Cyclacel’s President and Chief Executive Officer. “As with the fadraciclib studies, the Phase 1 stage of this trial will determine an optimal dosing regimen of oral CYC140 and provide insights with respect to safety, tolerability and clinical activity. The Phase 2 stage will enroll up to seven cohorts by histology and also a basket cohort. We expect initial data from this trial during the first half of 2023. We also look forward to reporting initial data from the fadraciclib clinical study in advanced solid tumors during the first half of 2022.”
“Overexpression of PLK1 is known to be important in many types of cancer,” said Mark Kirschbaum M.D., Senior Vice President and Chief Medical Officer. “We have optimized the properties of CYC140 to fit its apoptosis-driven mechanism, including a short half-life and differentiated structural and biological properties, compared to other PLK1 inhibitors in development. In preclinical studies CYC140 has demonstrated promising activity in multiple solid tumors and leukemias. The study has initially opened at City of Hope and MD Anderson Cancer Center with more sites to join later on. In addition to patients with certain PLK1 over-expressing tumors, the study will enroll patients with MYC amplified and KRAS-mutated cancers in which PLK1 inhibition may be effective. If successful, CYC140 may provide new treatment options for patients with advanced solid tumors or lymphomas.”
“As a key regulator of cell mitosis, PLK1 plays an integral role in prolonged survival of many cancer cells, including p53(-) and KRAS mutant genotypes,” said Miguel Villalona-Calero, M.D., co-leader of the Development Cancer Therapeutics Program and Professor, Department of Medical Oncology & Therapeutics Research at City of Hope, one of the largest cancer research and treatment organizations in the United States. “The totality of preclinical evidence suggests that CYC140 has significant potency and single-agent activity. This novel agent warrants clinical investigation across multiple solid tumors and lymphomas.”
The Phase 1/2 registration-directed trial, designated CYC140-101, uses a streamlined design and will first determine in a dose escalation stage the recommended Phase 2 dose (RP2D) for single-agent CYC140. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage CYC140 will be administered to patients in up to 7 mechanistically-relevant cohorts including patients with bladder, breast, colorectal (including KRAS mutant), hepatocellular and biliary tract, and lung cancers (both small cell and non-small cell), as well as lymphomas. An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MYC amplified tumors. The protocol allows for expansion of individual cohorts based on response which may allow acceleration of the clinical development and registration plan for CYC140.
