Abstract
3045 Background: Imprime PGG (IPGG) is a yeast-derived β-1,3/1,6 glucan that primes innate immune cells to kill antibody-targeted cancer cells via a complement receptor 3 (CR3)-dependent mechanism. In humans, naturally occurring anti-β-glucan antibodies (ABA) are required for binding of IPGG to CR3 and subsequent changes in innate cell functions. Methods: In a 32-donor healthy volunteer study, using a qualified quantitative ELISA assay, ABA levels and the threshold for binding and modulation of innate immune functions were evaluated, including a) complement activation, b) complement receptor expression, c) activation marker modulation, and d) selective chemokine production. The potential of the ABA level as a clinical biomarker for clinical response to IPGG was evaluated in a Phase 2 clinical trial by retrospectively segregating subjects into populations at or above the ABA threshold (biomarker positive; BM+) or below the ABA threshold (biomarker negative; BM-). Advanced NSCLC patients received cetuximab,...
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