This study examines the safety of its lead candidate, new HspE7 (HspE7 + Poly-ICLC, a toll-like receptor-3, or TLR3 agonist), in patients with cervical intraepithelial neoplasia (CIN), a precursor to cervical cancer.
When complete, the Phase I trial will have dosed four cohorts totaling 17 patients with a fixed dose of 500mcg of HspE7 and either 50, 500, 1,000 or 2,000 mcg of the adjuvant, Poly-ICLC. In addition to safety data, immunological data are being collected pre-treatment, following each dose of new HspE7, and at the end of the study from all patients, which could provide an early indication of potential activity of new HspE7. All patients are also being typed for class I and II human leukocyte antigen (HLA) subtypes, and are being evaluated for cytokine responses, anti-HspE7 antibodies and cellular (T-cell) immunology.
Gregory McKee, president and CEO of Nventa, said: “Following completion of this Phase I study, we anticipate launching a comprehensive Phase II program studying the safety and efficacy of new HspE7 in patients with CIN.”