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.

“This publication marks an important transition for Pinion from preclinical validation to a clinical-ready program with an FDA-cleared IND,” said Gregory Glenn, MD, Chief Executive Officer. “We believe the combination of our platform, formulation and therapeutic regimen gives ARV-2001 a strong foundation as we move into patients.”

Pinion’s first-in-human study, PIN-001, will evaluate ARV-2001 in women with HPV-16-positive CIN2/3, with histopathologic clearance of the cervical lesion as the primary endpoint.

The study was published in Vaccines (2026;14(8):714): https://doi.org/10.3390/vaccines14080714.

About Pinion Immunotherapeutics

Pinion Immunotherapeutics is a Maryland-based clinical-stage biotechnology company developing RNA immunotherapies for diseases and cancers driven by persistent viral infection. Its lead program, ARV-2001, has an FDA-cleared IND for HPV-16-positive cervical precancer. Pinion is also advancing programs targeting EBV, HSV and acute myeloid leukemia.

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"ARV-2001 is designed to clear precancerous cervical lesions without surgery...preserving the cervix and addressing the underlying HPV infection."