Almac’s novel biomarker platform for patient stratification within immune oncology clinical trials

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One of the major issues when conducting clinical trials (CTs) in cancer is the need to pre-screen patients with one or more genomic tests to determine if the patient is likely to respond to the proposed new therapy. Typically this means that a tumour biopsy may be required to obtain DNA or RNA to carry out the required genomic testing. Many modern clinical trials evaluate more than one different therapy option requiring a number of different genomic tests to be performed. This can mean that additional biopsies may be required to obtain sufficient genomic material for each test. This has the added issue of increasing the cost of the clinical trial and the potential to introduce delays in administering the appropriate therapy to the patient.The focus of this proposal is on the validation of a comprehensive gene expression (GE) platform that allows the expression levels of all 21,000 human genes to be evaluated in a single experiment. This means that any combination of gene expression tests can be evaluated in a single process using a single clinical sample. The proposal will see validation of the platform to meet all European and US regulatory requirements for use in clinical trials, ensuring it is safe and effective for patient testing. This will represent a major step forward for how we pre-screen cancer patients for enrolment into cutting edge clinical trials, ensuring that each patient has the opportunity to receive the optimal treatment based on their unique gene expression pattern.Almac will utilize its proprietary GE assays, including our immune oncology (IO) assay, as the proof-of-concept to deliver on this objective. Almac's IO assay is a 44 gene expression test that captures the complex biology underpinning response to immune checkpoint inhibitors (as published in JNCI 2014 & 2017). Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment: they disable the molecular disguise that cancer cells use to hide from the immune system, thereby allowing a patient's own defences to destroy tumours. Our platform will provide the one stop solution to select and stratify patients with different solid tumours within these studies, to improve patient outcome both in the clinical trial setting, in the near term, and subsequently in the clinic.