amcure has dosed the first patient in the extension cohort of a Phase I/Ib trial to investigate AMC303 for the treatment of patients with advanced metastatic malignant solid tumours of epithelial origin.

The extension cohort is the second part of the clinical trial and is based on positive safety and pharmacokinetic data received in the dose escalation part, as well as a recommendation by the data safety monitoring board.

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It expects to enrol patients with a moderate-to-high expression of the target molecule CD44v6 in four specific tumour types of squamous tumours, including head and neck squamous cell carcinoma (HNSCC), squamous non-small-cell lung carcinoma (NSCLC), esophageal and cervical tumours.

The Phase I/Ib trial aims to evaluate the safety, tolerability and pharmacokinetics of multiple and increasing doses of AMC303 as monotherapy in the enrolled patients.

“Our Phase I/Ib study with AMC303 is progressing as planned, demonstrating the safety and linear pharmacokinetic properties in a heavily pre-treated patient population.”

The trial is expected to enrol 50 subjects and is being conducted in Belgium and Spain.

It also comprises a comprehensive biomarker programme.

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amcure CEO Klaus Dembowsky said: “Our Phase I/Ib study with AMC303 is progressing as planned, demonstrating the safety and linear pharmacokinetic properties in a heavily pre-treated patient population.

“As drug combinations become increasingly the standard in today’s oncology practice, having a safe therapeutic option with a unique and additive mechanism of action would be an attractive asset.”

amcure’s AMC303 features a high specificity for inhibiting CD44v6, a co-receptor required for signalling through various cellular pathways, including c-Met, VEGFR-2, RON, involved in tumour growth, angiogenesis and the development and regression of metastases.