Pinion Immunotherapeutics Publishes Preclinical Data Supporting Clinical-Ready RNA Immunotherapy for HPV-16 Cervical Precancer
Pinion Immunotherapeutics has published preclinical data supporting ARV-2001, its lead RNA immunotherapy, in the peer-reviewed journal Vaccines. With an Investigational New Drug application cleared by the FDA, Pinion is ready to begin clinical development for women with HPV-16-positive high-grade cervical precancer (CIN2/3).
ARV-2001 is designed to clear precancerous lesions without surgery while preserving the cervix and addressing the underlying HPV infection. Pinion’s RNA immunotherapy platform combines optimized RNA design, a proprietary lipid formulation, intradermal delivery and a therapeutic regimen designed to generate a targeted T-cell response at the site of disease.
Women with CIN2/3, the immediate precursor to cervical cancer, are typically treated with LEEP, a procedure that removes cervical tissue. LEEP can carry reproductive risks and may not clear the underlying HPV infection. CIN2/3 is also well suited to an immune-based therapy: the disease is localized, the viral targets are defined, and response can be measured directly in cervical tissue.
ARV-2001 targets E6 and E7, two well characterized viral proteins that allow HPV-related precancer to persist. In the study, ARV-2001 encoded modified, non-oncogenic forms of E6 and E7 in Pinion’s proprietary lipid formulation. Intradermal administration outperformed intramuscular injection on tumor control, survival and E6/E7-specific T-cell responses while limiting systemic exposure. The findings established the formulation, delivery method and regimen Pinion will take into the clinic.
