10085660Beacon: a companion diagnostic for cyclin dependent kinase inhibitorsClosedCollaborative R&DInnovate UKThe NHS Long Term Plan on cancer endeavours to enable 55,000 more people to survive their cancer diagnosis by 5 years or more by 2028\. In recent years, targeted therapies have been improving survival for cancer patients compared to chemotherapy. While chemotherapy creates a generally hostile environment for cancer (and healthy) cells, targeted therapies target specific differences between cancer and healthy cells to stop just the cancer cells from reproducing. Often, this has significantly fewer side effects for patients. Cyclin dependent kinase inhibitors (CDKi's) target a particular type of protein, called an enzyme, that is involved in excessive cancer cell division. Three CDKi's have been approved for the treatment of advanced breast cancer in the UK and globally. Recently, after cancer patients advocated for extending CDKi access, the UK has approved treatment of early-stage breast cancer patients at high risk of recurrence with one of these drugs. The mechanism that CDKi's target is common to many other types of cancers, not just breast cancer. Therefore pharmaceutical companies are working to develop CDKi's for other solid tumour cancers (e.g., lung, prostate, colorectal, brain) and blood cancers. In order to be approved and extend access to CDKi's to more patients, these new drug candidates need to increase patient survival compared to standard-of-care. The problem is that from already approved CDKi's, we know that approximately 20% of patients don't respond to these drugs. That means that these patients could be treated more effectively on other therapies. There is currently no way to predict which patients will not respond. Without the ability to stratify patients to the correct therapy, this 20% failure rate could compromise CDKi effectiveness in clinical trials and put regulatory approvals at risk. Through this project, Proteotype will develop the first patient stratification tool for CDKi's. This blood test detects a signature of how the immune system activates to fight tumour development. We already have preliminary strong evidence of clinical effectiveness (N=30 patients), and now need to further develop our product and evaluate its effectiveness in an N=100 prospective patient population. The Southampton Adult Cancer Patient and Public Involvement group will confirm acceptability of all patient-facing materials. The project will refine the blood test's AI algorithms, develop a cloud platform where clinicians can readily access results, manufacture it's assay kit to international standards, develop it's quality management system, regulatory, and commercial strategy. The result is accelerated market entry for patient benefit.