Table 4. . Immune analysis cohort.
| Enrollment number | Dose of WP1066 mg/kg | % of p-STAT3+ PBMC | % of FoxP3 Tregs | % IFN-γ+ CD8 T cells | Th1 to Th2 ratio† | Cytotoxic CD8 to Treg ratio‡ | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C1D1 0 h |
C1D1 4 h |
C1D2 0 h |
C1D8 0 h |
C1D8 4 h |
C1D1 0 h |
C1D8 4 h |
C1D1 0 h |
C1D8 4 h |
C1D1 0 h |
C1D8 4 h |
C1D1 0 h |
C1D8 4 h |
||
| 1 | 1 | 39.9 | 33.4 | 31.8 | 19.3 | 15.7 | 6.9 | 3.9 | 8.3 | 45.3 | 0.3 | 1.0 | 1.2 | 11.7 |
| 2 | 2 | 38.1 | 33.8 | 31.5 | 27.6 | 34.8 | 8.8 | 7.6 | 8.8 | 7.0 | 0.8 | 0.5 | 1.0 | 0.9 |
| 3 | 4 | 35.0 | 28.2 | 26.9 | 37.7 | 22.7 | 5.3§ | N/A§ | 4.6 | 0.1¶ | 0.1 | 0.2 | 0.9 | N/A |
| 4 | 4 | 27.8 | 30.9 | 29.7 | 27.3 | 21.1 | 4.9 | 8.4 | 0.9 | 0.5 | 0.6 | 0.4 | 0.2 | 0.1 |
| 5 | 4 | 35.9 | 36.0 | 45.8 | N/A | 35.3 | 4.0 | 5.9 | 4.0 | 14.7 | 0.4 | 1.4 | 1.0 | 2.5 |
| 6 | 8 | 16.9 | 20.2 | N/A | 17.9 | 12.0 | 6.9 | 5.8 | 31.7 | 0.1 | 12.9 | 1.8 | 4.6 | 0.0 |
| 7 | 8 | 43.8 | 31.0 | 33.5 | 22.2 | 24.7 | 3.7 | 5.4 | 27.4 | 3.6 | 0.1 | 2.4 | 7.4 | 0.7 |
| 8 | 8 | 56.9 | 77.6 | 68.9 | 67.7 | 78.0 | 2.4 | 2.1 | N/A# | N/A# | N/A# | N/A# | N/A# | N/A# |
†
The percentage of CD3+ CD4+ IFN-γ+ T cells is divided by the percentage of CD3+ CD4+ IL-4+ T cells.
‡
The percentage of CD3+ CD8+ IFN-γ+ T cells is divided by the percentage of CD3+ CD4+ CD25+ Foxp3+ cells.
§
Time point analysis confounded by a technical issue but there was a reduction of CD3+ Tregs from 2.2 (C1D1 0 h) to 0.8% (C1D8 4 h).
¶
No IFN-γ, but there was 0.1% C1D1 0 h to 5% TNF-α expressing cells on C1D8 4 h.
#
No cytokine analysis possible because of the Covid-19 related shift work.
C: Cycle; D: Day; h: Number represent h relative to the administration of WP1066; N/A: Not available; PBMC: Peripheral blood mononuclear cell.