Clinical biomarkers

At KWS BioTest we specialise in mapping immune function in the clinic. We understand that in early phase clinical trials, biomarker efficacy data generated with only a small proportion of the clinical budget may crucially contribute to the decision to progress.

Clinical Biomarker Services

CEO Dr Robin Brown and CSO Professor Neil Williams discuss the company's clinical services.

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How we can help

Through implementation of a validated set of analytical, cellular and even functional assays, as part of the clinical team in Phase 0-2 studies, we are able to confirm that the drug is engaging with the target and is having the effect predicted. In addition, we can identify early warning signs related to immune toxicology, if these are present. 

We support our clients in the preclinical phase of their projects to identify potential biomarkers, and can support projects already entering the clinic to implement appropriate assays.

KWS BioTest Clinical Biomarkers Blog

Read our latest blog posts on clinical biomarkers.

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Adding value for our clients:

Pharmaceutical companies: 

Our clinical biomarker offering helps you select which drugs and targets to progress. We save you money by ensuring you back the winners and make the right choices from your portfolio.

Biotech companies: 

We provide you with evidence that your molecule works before you commit to the expense of larger clinical trials. 

Early PD and immunotoxicology data allows you to be smarter in your choices and more cash efficient in your development programme.

CRO partners:

With our state-of-the-art facilities and world-leading expertise we can help you expand your client offering.

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These are some of the ways that we have studied PD biomarkers to help our clients:

Confirming mechanism of action (MOA): 

We identify and monitor PD biomarkers that confirm the MOA. If your molecule affects the immune system, we can employ analytical, cellular or even functional assays to confirm that your molecule interacts with its target modulating immunological function as anticipated.

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Spotlight assay

Ex vivo functional assays are employed within multicenter clinical trials, in order to demonstrate changes in T cell differentiation

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Efficacy predicting: 

By carefully analysing drug effects in the patient, our platforms support your drug discovery and development programmes, providing high quality data early in the process that will underpin the critical decisions taken to progress a molecule.

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Spotlight assay

The consequences of novel treatments on the ability of patient derived cells to produce inflammatory and anti-inflammatory cytokines are assessed in validated assays.

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Immunotoxicity testing:

Using our assays and our immunology expertise, we use biomarkers to look at how your molecules are affecting the immune system and can help you identify any potentially undesirable drug effects and help you to mitigate any risk.

Spotlight assay

Some therapeutics have the potential to cause cellular activation and inflammatory cytokine production, which can be assessed both pre-clinically and clinically

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The potential for compounds to drive unwanted cytokine production can be benchmarked against existing biologics such as Orthoclone OKT3 and Lemtrada

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KWS BioTest considers the use of early clinical markers of efficacy to be an important part of any programmes clinical strategy.

Early efficacy indication(s), together with immunotoxicology prediction, make for better decisions in the clinic.