Completed Cancer Digestion, Kidneys & Other Organs

'First-In-Human' directed pre-clinical development of anti-cancer agent CYC140

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AI plain-English summary

A drug candidate called CYC140 is being readied for first human tests against oesophageal cancer, a disease with few treatment options. This matters because oesophageal cancer is an orphan disease with high unmet need, and the compound targets a mechanism—PLK1 kinase inhibition—that has not been exploited before for this cancer type. The drug is designed as a stratified medicine, meaning it would be given only to patients whose tumours carry particular driver mutations. The project includes preclinical validation of marker assays to identify those patients, safety studies needed before first-in-human testing, and formulation and manufacture of the drug for Phase 1 trials. The compound will also be tested in combination with other approved and investigational drugs in disease models. If successful, the work would attract further investment in a UK and EU development programme, securing additional jobs and giving solid tumour patients with poor prognosis access to a new investigational medicine.

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Cyclacel has developed a clinical candidate NCE with characteristics enabling the targeting of a previously unexploited mechanism for treatment of oesophageal cancer (OEC), an orphan disease with a high unmet need. This potent and selective PLK1 kinase inhibitor has a strong preclinical rationale for use as a stratified medicine for OEC and other solid tumour indications having particular driver mutations. The drug development project encompasses preclinical validation of marker assays for clinical stratification of patients, 'First-In-Human' (FIH)-directed safety studies, clinical formulation and manufacture for Phase 1 testing, and testing of the compound in combination with approved and investigational therapeutic agents in models of the target diseases. Success will attract further investment in a UK and EU based development program, securing additional jobs and will provide access to a new investigational medicine for solid tumour patients with poor prognosis diseases.

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