ImCheck

Context

ImCheck’s Phase 1b AML trial showed early promise — but with no control arm, they couldn’t demonstrate to regulators what their drug was actually contributing. They needed a credible comparator. We built one.

What We Did

We sourced a real-world dataset of AML patients on the same standard-of-care regimen, matched them to ImCheck’s trial participants on key clinical factors, and packaged everything to FDA evidentiary standards.

• Structured ImCheck’s trial records to enable propensity matching
• Built a matched virtual comparator arm from 300+ real-world patients
• Delivered a regulatory-ready output for FDA submission and ASH presentation

Impact

The analysis gave ImCheck a statistically credible case for Breakthrough Therapy Designation — something a single-arm trial alone couldn’t provide. The propensity-matched comparison showed a 27-point improvement in response rate for patients on ICT01 vs. standard of care. When Ipsen acquired ImCheck later that year, our work was cited as a core data asset in the deal.