HspE7 is an investigational therapeutic vaccine targeting human papillomavirus (HPV)-related diseases. The trial is expected to dose up to five cohorts comprising twenty-four patients. The first cohort of patients was administered 500mcg of HspE7 and 50mcg of adjuvant containing Poly-IC, a toll-like receptor-3 (or TLR3) agonist. The second cohort was administered 500mcg of HspE7 and an escalated dose of 500mcg of adjuvant. The third cohort was administered 500mcg of HspE7 and 1000mcg of adjuvant, and the fourth cohort will be administered 500mcg of HspE7 and 2,000mcg of adjuvant. An additional cohort of six patients administered 1,000mcg of HspE7 and 2,000mcg of adjuvant may be added if deemed appropriate based on data from the previous four cohorts.
Immunological data from these patients will be collected at the end of each cohort. All patients will be typed for class I and II human leukocyte antigen (HLA) subtypes, and will be evaluated for cytokine responses, anti-HspE7 antibodies and cellular (T-cell) immunology. Following successful completion of this Phase I trial, the company anticipates launching a Phase II clinical trial with new HspE7 in patients with high-grade cervical intraepithelial neoplasia (CIN 2/3).