Clincal Utility
of P-TopoI-Dx
Clinical Utility and Market Share: TopoI inhibitors are used to treat colorectal, gastric, pancreatic, ovarian, breast, and small cell lung cancer. CRC is the third-most common form of cancer and the second leading cause of cancer-related death in the US. Despite progress in effective screening, 20% of patients present with metastatic disease, and another 20% develop metastasis during clinical courses. The standard first line therapy for mCRC is 5FU and leucovorin, combined with either oxaliplatin (FOLFOX) or irinotecan (FOLFIRI). These doublets, depending on the status of the RAS gene, are combined with targeted drugs. The selection of chemotherapy as first or second line is not based on any predictive biomarker and the response rate of FOLFOX and FOLFIRI is similar. However, due to the failure of first line therapy, many patients do not get second line therapy. P-topoI-Dx has the potential to change the treatment paradigm in advanced CRC therapy management. Similarly, in pancreatic and gastric cancer therapy the predictive biomarker can be used very effectively to determine the best first line therapy options.
"Irinotecan is an important drug in CRC, a mainstay. It can be used in first, second and occasionally perhaps third line. Even with the new treatment in the future, they'll still be deployed with a FOLFIRI/FOLFOX background. It's not going away" -Academic Medical Oncologist
Cancer Incidence and patient population eligible for topoI inhibitors: TopoI inhibitors are one the most extensively-used drugs in oncology. Predictus Biosciences will target the global companion diagnostics market, which is projected to reach USD $7.3 billion by 2024 from USD $3.5 billion in 2019, at a CAGR of 15.7%. Within the global companion diagnostics market, the global oncology companion diagnostic market size was valued at USD 2.2 billion in 2019 and is expected to grow at a CAGR of 12.7% from 2020 to 2027.
Cancer Incidence and patient population eligible for topoI inhibitors: TopoI inhibitors are one of the most extensively-used drugs in oncology. Recent approvals of two ADCs have further increased the clinical use of this class of drugs.
ADCs and TopoI Inhibitors: Antibody Drug Conjugates (ADCs) are the fastest growing class of drug. ADCs have shown impressive response in refractory cancers. However, their wider clinical application faces several challenges, including systemic toxicities, suboptimal biomarkers, and poorly understood pathways of drug resistance. Topoisomerase I (topoI) inhibitors are projected to be the most successful cytotoxic payloads used in ADCs and our predictive biomarker, P-topoI-Dx, will be critically important for successful clinical trials of novel and FDA-approved ADCs with topoI inhibitor payloads. Currently, ADCs with topoI inhibitors are projected to capture 40% of the ADC market share.
-Global sales of currently-marketed ADCs are forecasted to exceed $16.4B
-- Sales of Tratuzumab Deruxtecan and Sacituzumab Govitecan, two topoI inhibitors containing ADCs, are projected to be $7.3B.