Developing entrepreneurial skills for the BIOCLIN software platform to support biomarker clinical trials

Genomic biomarkers enable precision medicine by matching patients to their optimal treatments. Mutational biomarkers are used as standard practice for oncology patients to assign them to treatment. However, mutations don’t have the predictive power for several therapies, including immunotherapy, which results in complete and durable responses for a subset of cancer patients. RNA sequencing (RNAseq) has been shown to improve accuracy over mutations in preclinical studies, including being able to predict response to immunotherapy, and even mutational status. The global RNAseq market is currently estimated at 9 billion dollars and is expected to grow at an annual rate of 10% from 2023 to 2030. The number of RNAseq biomarker trials has already doubled in 2020-2023 compared to 2010-2020, based on data in clinicaltrials.gov. RNAseq biomarkers currently face three major challenges: (1) bioinformatics analysis to translate signatures, cutoffs, etc. for application in the clinic, (2) regulatory issues with reproducibility and clinical validation, and (3) lack of software platforms to provide clinical trial support for biomarkers. There is currently no commercial software to support patient selection based on their RNAseq profiles at baseline, to the best of our knowledge. We have developed a prototype software suite, BIOCLIN, for an ongoing multi-site phase II RNAseq biomarker trial in kidney cancer (NCT05361720). It includes analysis of RNAseq data for each patient on the fly, run machine learning models and display gene signature scores per patient in an easy to use, intuitive user interface. Our goal is to develop our prototype into a commercial product with additional functionality that can be used to rapidly deploy platforms to support biomarker-based trials. In this proposal, we are applying for our three-person team to participate in the ICorps program to learn more about successful commercialization strategies for our product, BIOCLIN.