Table 3.
Biodistribution and biological activity of single agent OH2 in phase I*
| Patient | Dose level (CCID50/mL) |
Tumor types | Blood OH2 viral loads (copies/μL, timepoint) | Tumor GM-CSF mRNA levels (copies/μL, timepoint) | Blood GM-CSF expression (pg/mL, timepoint) | Blood anti-GM-CSF antibody (timepoint) | Best response (RECIST version 1.1/iRECIST) |
| 1 | 106 | Esophageal cancer | BQL | 1.24×104 (C1D3) | BQL | Negative | PD/iPR |
| 2 | 106 | Esophageal cancer | BQL | BQL | BQL | Negative | PD/iUPD |
| 3 | 106 | Breast cancer | BQL | BQL | BQL | Negative | PD/iUPD |
| 4 | 107 | Rectal cancer | BQL | BQL | BQL | Negative | PR/iPR |
| 5 | 107 | Esophageal cancer | BQL | 1.01×104 (C1D3) | BQL | Negative | NA |
| 6 | 107 | Head and neck cancer | 3.38×103 (C1D1, 1 hour) | BQL | BQL | Negative | PD/iUPD |
| 7 | 107 | Appendix cancer | BQL | BQL | BQL | Negative | SD/iSD |
| 8 | 108 | Esophageal cancer | 1.43×103 (C1D7) | 1.41×103 (C3D1) | 17.37 (C2D1) 19.40 (C3D1) |
Negative | PD/iUPD |
| 9 | 108 | Esophageal cancer | BQL | 1.00×104 (C1D3) | BQL | Negative | PD/iUPD |
| 10 | 108 | Gastric cancer | 3.76×103 (C1D2) | 1.72×104 (C1D3) | 30.07 (C1D2) 20.98 (C1D3) |
Negative | NA |
| 11 | 108 | Ovarian cancer | 4.38×104 (C1D7) | BQL | BQL | Transient positivity (C3D1) | SD/iSD |
*The biodistribution studies included OH2 viral DNA in the blood, saliva, urine, and injection site swabs. The results for saliva, urine and injection site swabs were all negative and not shown in the table. The results for blood OH2 viral loads, with values and timepoints of sample collection, are listed.
BQL, below quantifiable limit; C1D1, the first day of cycle 1; 1 hour, one hour (after injection with OH2); iUPD, immune-unconfirmed progressive disease; NA, not available; PD, progressive disease; PR, partial response; SD, stable disease.