VB10: Interim Phase I/IIa data

Interim data from 16 patients in the Phase I portion of the open-label, German Phase I/IIa VB C-01 trial showed that 3 doses of 3 mg intramuscular VB10.16 were well tolerated with no serious adverse events reported. Cohort 1 (n=8) received VB10.16 at weeks 0, 3 and 6, while cohort 2 (n=8) received VB10.16 at weeks 0, 4 and 12. In 14 evaluable patients, 12 patients (86%) achieved “strong induction” of HPV16-specific T cell immune responses. Vaccibody said cohort 1 achieved a “more rapid, stronger and longer-lasting T cell response” vs. cohort 2. In 8 evaluable patients from cohort 1, 4 patients (50%) regressed to low grade neoplasia of CIN grade 1 or no disease at 4 months of follow-up. In 4 evaluable patients from cohort 1, 3 patients (75%) regressed to CIN grade 1 or no disease at 6 months of follow-up. ...