Beyond Genomics: AI-Directed Functional Precision Oncology
On June 5, 2023 SOTERIA Precision Medicine Foundation executed a fiscal sponsorship agreement with Certis Oncology Solutions, a San Diego-based precision oncology and translational science company. The agreement will support an observational clinical research study aimed at validating the application of “mouse avatars” as a clinically relevant platform for precision oncology and evaluating the clinical utility of the patent-pending CertisAI™ platform, which uses multivariate analyses and gene expression biomarkers to predict drug response. The Project will focus initially on colorectal and other cancers that commonly carry KRAS mutations. All testing will be performed in Certis’ CLIA-certified laboratory.
WHY IS THIS IMPORTANT?
The United States health care system relies upon a set of protocolized “standard of care” (SoC) guidelines that recommend treating whole populations of patients based largely on tumor site, and in some cases, the existence of biomarkers and/or genetic mutations that may or may not be driving an individual’s cancer. For over 60 years, this reductionist approach to cancer treatment has produced outcome failure-rates of 90% (±5). If SoC therapy fails, people with cancer generally undergo a series of trial-and-error treatments that often lead to toxic side effects, a diminished immune system, emotional stress, and financial hardship. Not only does this process harm patients, it creates unnecessary expense within an already cost-burdened healthcare system.
HOW THIS PROJECT BEGAN
In 2022, Certis Oncology Solutions, Inc, (Certis) and Aspect Imaging, Ltd, (Aspect) launched a pilot study to test a hypothesis that Artificial Intelligence-guided, MRI-validated functional assays using personalized, orthotopic patient-derived xenograft (O-PDX) models could accurately predict therapeutic response to various treatment options, in mouse models.
During the conduct of the pilot study, Certis scientists discovered intriguing biomarker patterns predictive of favorable response, in mouse models, to existing therapies not currently indicated for certain “untreatable” forms of cancer. AI-enabled predictions were tested in vivo, tumor regression was measured by MRI, and results were confirmed by histology. Early findings compelled a deeper interrogation of public in vitro and clinical outcomes datasets. All findings point to an opportunity to repurpose existing, FDA-approved drugs that may improve clinical outcomes for individuals diagnosed with colorectal and other cancers with KRAS mutations, as well as other potentially actionable targets.
BENEFITS OF THIS PROJECT
This Project may benefit participants for whom no standard-of-care option is available by providing treating oncologists with hypothesis-generating drug sensitivity data that may help inform next-line treatment decisions. If AI-identified predictive biomarkers are validated in vivo, results from this Project also may inform future clinical trials to determine whether using already-approved drugs in combination can effectively treat subpopulations of patients with unmet needs. Ultimately, this Project will benefit all individuals who will be diagnosed with cancer in their lifetime by advancing science in both functional precision oncology and AI-enabled predictive medicine.
All donations received by SOTERIA for the purposes of the Project will be placed into a restricted fund to be devoted to the purposes of and for the sole benefit of this Project's mission.