OncoSec Medical Inc (ONCSQ)

[hschlauch]

I agree with you on that point lowe, the biomarker is not a validated one; it hasn't gone through years of rigorous confirmation or approval yet.

What they are using is an exploratory biomarker assay that was developed following a retrospective analysis. The company believes that the "validation cohort" study (remember, they developed a testable hypothesis based on an earlier inductive review of exhausted TIL phenotypes in a 20-patient discovery cohort) of 20 patients led by the UCSF supports the discovery cohort findings. The whole point of the biomarker assay developed by the UCSF is to inform future trial designs and inclusion/exclusion criteria.

The facts are:

The validation cohort data confirmed the discovery cohort data. More specifically, 100% of patients with >30% pd-1/CTLA-4-positive TIL phenotype responded to monotherapy Keytruda, while 100% of patients with <20% pd-1/CTLA-4-positive TIL phenotype did not respond to monotherapy Keytruda.

So, why use the exploratory biomarker in the phase II EP IL-12/pembrolizumab study? The answer is it helps with the design and inclusion/exclusion criteria of future studies. It establishes confidence and informs registration trial inclusion/exclusion criteria. This doesn't mean they will necessarily use the biomarker in the registration study.

The FDA recognizes exploratory biomarkers for decision making purposes. They are very useful even if they aren't yet validated.