A companion diagnostic is a diagnostic test used in conjunction with a therapeutic drug to determine who is likely to respond to the therapy. Clarity, through its SAR technology and the use of copper-64, is able to take this to the next step of also tailoring the dose of therapy to a specific patient. This personalisation allows the enhancement of efficacy and minimisation of side effects, assisting in making the most optimal treatment decision possible for the patient.
Companion diagnostics hold the promise of improving the predictability of the drug development process with a number of drug-diagnostic or “theranostic” co-development programs successfully implemented.
Using companion diagnostics in drug development helps to see where the drug goes inside the body, predict likely response and toxicity, confirm mechanism of action and compare drug candidates. This information allows drug developers to de-risk the development process.
Outside of the use of companion diagnostics in the cancer program, Clarity currently has two companion diagnostics in development in the areas of vulnerable plaque (cardiovascular disease) and fibrosis. There is a significant unmet need for better diagnosis and treatment for both of these conditions.
A vulnerable plaque is a type of atherosclerotic plaque that is characterised by inflammation and a collection of white blood cells in the wall of arteries. It is particularly susceptible to rupturing and can result in coronary-artery blockage (i.e. occlusion) resulting in a heart attack.
It has recently been discovered that vulnerable plaque is a leading underlying cause of the majority of heart attacks and usually has no prior symptoms. Around one quarter of patients die from the acute event and one in four people who die from a heart attack die within the first hour of their first symptom. Survivors have a higher risk of recurrent heart attacks or cardiac death, and a further 10% die within two years. Only 50% of initial survivors are alive at 10 years.
Being able to diagnose rupture prone plaque would help to prevent heart attacks and ensure long-term survival of the patients.
Clarity’s companion diagnostic, PlateView™, is a radiolabelled antibody which targets rupture prone plaque, which can be detected using PET imaging.
This product is being developed in Belgium with a Grant from the Belgium Government.
There is an immediate need for a biomarker to monitor progression of fibrotic disease during clinical trials of new therapeutic compounds for fibrosis.
Clarity’s radiolabelled molecule targets fibrosis concentrated in prone tissues and can be detected using PET imaging.