Problem

The global immune checkpoint inhibitor (ICI) market is ~$60B. However, only ~20% of patients derive long-term survival benefit. The current standard of care biomarker Tumor Mutation Burden (TMB) performs poorly and there is no universal biomarker with robust validated predictive ability.

Opportunity

A companion diagnostic for identifying patients who benefit with ICI would unlock a large market by improving patient outcome and enabling a pan-cancer treatment indication that helps newer market entrants to better compete with incumbents.

Solution

• Genomic Score that Predicts Survival: We have developed a pan-cancer genomic scoring system encompassing ~170 genes that predicts long term survival with immune checkpoint inhibition (ICI)
• Derivation: Developed from next-generation sequencing genomic data from 54 Neuroendocrine neoplasms who received ICIs at OSU
• Validation: Performed by analyzing and scoring 20,563 genomic alterations in 1,662 ICI treated patients with 10 different cancers from a publicly available dataset. (Samstein et al., Nature Genetics 2019).
• Broad Applicability: NSCLC, Melanoma, Colorectal Cancer, Bladder cancer and Neuroendocrine Neoplasms.

Competitive Advantage

• The genomic score performed better than the TMB score (current standard of care)
• AUC of 0.87-0.95 for genomic score vs AUC of 0.57 for TMB
• Predictive of survival in 5 types of cancer including NSCLC

Applications

• Biotech/Pharma companies: Develop a companion diagnostic to facilitate ICI drug development and improve patient outcome that leads to a new pan-cancer treatment indication that competes strongly with established players such as Keytruda and Opdivo which lose patent exclusivity within 3 years
• Payors/Nationalized Health Systems: Accurately predicting survival benefit helps maximize benefit from expenditure on ICI