Nabil

Nabil, on behalf of Roger Song, asked if the CD47 cut point for the ASPEN-09 primary endpoint is already locked in, and about the pre-specified decision rules for selecting that cut point. He also inquired about IHC evaluability, specifically how borderline cases or insufficient tissue are handled.

Answer

CEO Jason Lettmann stated that CD47 expression is anticipated to differ across tumor types (gastric vs. breast), and the current study aims to precisely understand where to set the optimal cutoff. CMO Barbara Klencke added that tissue submission is required for all patients, with an expectation of 10% or less missing data due to insufficient tissue. She noted that IHC is a standard and straightforward assay methodology, posing no major risks to evaluability.

Nabil asked if the CD47 cut point for the ASPEN-09-Breast trial's primary endpoint is already locked in, and if not, what pre-specified decision rules are being used to select it. He also inquired about how borderline cases or insufficient tissue for IHC evaluability would be handled.

Answer

Jason Lettmann, CEO, explained that while CD47 expression is anticipated to differ across tumor types, the current ASPEN-09-Breast study is designed to precisely define the optimal cutoff. He noted that tissue at the time of diagnosis is used, and CD47 expression is expected to be relatively stable, minimizing issues with missing tissue. Dr. Barbara Klencke, CMO, added that tissue submission is required for all patients, and while rare instances of insufficient tissue might occur (estimated 10% or less), IHC is a standard and reliable assay methodology.