Fig. 3: Robust direct ex vivo mKRAS-specific T cell responses induced by ELI-002 2P in a majority of patients.

Patients were immunized with 1.4 mg of Amph-Peptides 2P admixed with 0.1, 0.5, 2.5, 5 or 10 mg of Amph-CpG-7909. PBMCs were collected for T cell response assessment at baseline and post-immunization timepoints. a, Shown is the fold change from baseline to maximum response in the ex vivo FluoroSpot assay or ICS assay for T cell responders (n = 21/25 patients). T cell responders are defined as patients having a ≥2-fold increase from baseline at any post-vaccination timepoint (dotted line) and >50 SFCs/1 × 106 PBMCs for FluoroSpot assay or >0.1% cytokine-positive for ICS assay. The median fold change is shown at 12.75, indicated by a dashed line. * Patients without baseline-detectable T cell responses (below the response threshold) had on-treatment fold change of 348×, 58.3×, 20.7×, 18.3×, 9.7×, 3.7× and 2.1×. b, Pie chart shows the percentage of T cell responders and non-responders to ex vivo FluoroSpot and ICS. c, Table shows the percentage of T cell responders to ex vivo FluoroSpot and ICS and average fold change of T cell responders per dose cohort. d, Pie chart depicts the percentage of T cell responders that induce CD4+, CD8+ or both CD4+ and CD8+ cytokine-positive cells in ICS assay. e, Pie chart indicates the percentage of T cell responders that induce T cell responses to 1, 2–4, 5–6 or all 7 assessed mKRAS antigens. f, Pie chart shows the percentage of T cell responders that induce T cell responses to immunizing antigens G12D and/or G12R. g, Bar graph indicates the number of mKRAS antigens that induced T cell responses after vaccination for each patient, n = 25. h, CD3 immunohistochemical analysis of hepatic tumor biopsy tissue section collected from patient 2 after observation of a contrast avid lesion by computed tomography (CT) 33 d after the start of treatment. Twenty-four CD3+ T cells per high-powered field (×400) were quantitated by the study pathologist in the region of highest labeling. i, CD3 immunohistochemical analysis of hepatic tumor biopsy tissue section collected from patient 18 after observation of a contrast avid lesion by CT. Seventy-six CD3+ T cells per high-powered field (×400) were quantitated by the study pathologist in the region of highest labeling. Pt., patient.