Immunology Data Shows INOVIO’s INO-3107 Induced Expansion of New Clonal T Cells That Infiltrate Airway Tissue and Correspond With Reduction of Surgeries for RRP Patients Observed in Phase 1/2 Trial

• New immunology data shows INO-3107 induced an expansion of new clonal T cells in blood that were not detectable prior to treatment
• New clonal T cells in the blood travelled to papilloma and airway tissues and generated an inflammatory and anti-viral response consistent with a reduced need for surgeries for patients with recurrent respiratory papillomatosis (RRP) caused by HPV-6 and HPV-11
• Data supporting mechanism of action for INO-3107 to be presented at 36th International Papillomavirus Conference in Edinburgh, UK

Excerpt from the Press Release:

PLYMOUTH MEETING, Pa., Nov. 13, 2024 /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced new immunology data that supports the clinical activity of its lead product candidate, INO-3107, that was previously observed in a Phase 1/2 trial of RRP patients. In that prior trial, patients experienced a reduction in surgeries needed to control their RRP caused by HPV-6 and HPV-11. In the recent immunology study, INO-3107 induced the expansion of both existing and new clonal T cells that travel from the blood to the papilloma and airway tissues. The new clonal T cells accounted for the majority of T cells observed in patient papilloma or airway tissue who showed either a complete or partial response to treatment with INO-3107. These new data build upon previously reported evidence that INO-3107 elicits an antigen-specific immune response targeting HPV-6 and HPV-11, to help eliminate or control RRP by reducing the need for surgery.

“These new immunology data are consistent with the clinical effect observed in our Phase 1/2 trial of elimination or reduction in the incidence of papilloma in the airway of RRP patients,” said Dr. Matthew Morrow, INOVIO’s Vice President of Translational Sciences. “In a thorough immunological assessment, we observed that T cell infiltration in airway tissues of clinical responders was predominantly comprised of a T cell population detectable only after administration of INO-3107. This evidence supports the mechanism of action of INO-3107 and its ability to induce antigen-specific cytotoxic T cells targeting HPV-6 and HPV-11. Furthermore, this data adds to the body of evidence indicating that DNA medicines are an effective CD8 T cell generating platform.”

Bettie M. Steinberg, Interim Dean and Professor, Elmezzi Graduate School of Molecular Medicine, Northwell Health, said, “This is very encouraging data. Not only did most patients improve clinically with INO 3107 treatment, but the induction of a systemic inflammatory T-cell response and new T-cell clones that travel to the papilloma tissue to contribute to a cytotoxic response shows that it is possible to effectively address the immune dysregulation against HPV that is a hallmark of RRP.”

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