Clinical feasibility of in vitro diagnostic drug testing for pancreatic cancer

Pancreatic cancer has the lowest survival rate among major cancers. Each year, it claims almost 500,000 lives globally, making up 5% of all cancer-related deaths. The treatments available, like chemotherapy and targeted therapies, show a response rate of less than 25%. This highlights the urgent need for better methods and therapies tailored to individual patients. Oncosyne is developing cell-based in vitro diagnostics (IVD), designed to pick the most effective drug therapy for each individual pancreatic cancer patient. How does it work? By screening the patient's own living cancer cells with a range of drugs and drug combinations in the laboratory. The unique analysis of how these cells respond forms the basis for a personalized diagnostic report. The treating physician then uses this report to customize subsequent drug regimens, potentially increasing the number of patients benefiting from anti-cancer drug therapies and reducing unnecessary side effects. Pancreatic cancer presents several unique challenges, one being high infiltration of so-called cancer-associated fibroblasts (CAFs). These non-cancerous cells limit drug effectiveness and promote drug resistance. To model this aspect, cancer-CAF co-cultures are necessary. To this end, in a collaborative effort, Oncosyne and the University of Oslo are using cutting-edge technology to develop an organ-on-a-chip co-culture module for more clinically relevant drug activity assessments. To test the effectiveness of this method, an exploratory interventional trial will be performed in collaboration with Sahlgrenska University Hospital. The IVD test will provide guidance for further drug treatment of patients with pancreatic cancer resistant to standard-of-care therapy. The study will employ end-to-end standardized and scalable assay conditions to facilitate transfer into clinical routine, if successful.

Pancreatic cancer has the lowest survival rate among major cancers and yearly accounts for nearly 500,000 (5% of total) cancer deaths worldwide. Available chemotherapies and targeted therapies have response rates below 25% creating an urgent need for new therapies and methods that can select effective therapies for individual patients. The innovation is a new in vitro diagnostic (IVD) test for selecting the most effective drug therapy for individual pancreatic cancer patients. The IVD is based on drug screening of the patient’s own living cancer cells and performs a unique analysis of the cells’ response to a range of clinically relevant drugs and drug combinations. The results are fed into a nomination algorithm that generates a personalized diagnostic report. The treating physician uses the report to tailor subsequent drug regimens. This approach has the potential to dramatically increase the number of pancreatic cancer patients benefiting from anti-cancer drug therapies and reduce the costs from unnecessary side effects. Pancreas cancer is characterized by high infiltration of cancer-associated fibroblasts (CAFs) limiting drug penetration and promoting drug resistance. In this interdisciplinary project Oncosyne and partners will leverage the core technology platform and develop a dedicated organ-on-a-chip co-culture module to evaluate the impact of the tumor microenvironment on drug activity. The clinical feasibility and utility of the method is uncertain and will be addressed in an exploratory interventional, open-label, randomized control trial. Here, the IVD test will be used to guide drug treatment for patients with metastatic pancreas cancer refractory to 1st line standard-of-care therapy. The study will employ end-to-end standardized and scalable assay conditions to facilitate transfer into clinical routine if successful.