INO-3107 Recurrent Respiratory Papillomatosis May 2023
IInovio Pharmaceuticals, Inc. INO-3107 DNA medicine vaccine candidate is being evaluated for the treatment of Recurrent Respiratory Papillomatosis (RRP), which is a rare disease caused by human papillomavirus (HPV) types 6 and 11 infections that are characterized by the growth of tumors in the respiratory tract caused by HPV.
Inovio Inc.'s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Administration with the CELLECTRA device ensures that DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response.
On February 10, 2020, the Company announced the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application to evaluate its DNA medicine INO-3107 in a Phase 1/2 trial for the treatment of RRP. In addition, the Company announced in October 2022 treatment with INO-3107 resulted in 16 of 21 (76%) participants with a reduction in the number of surgical interventions compared with the previous year; six participants required no surgical intervention during the trial, and INO-3107 demonstrated statistical significance based on the clinical endpoint of reduction in the overall number of surgical interventions compared with the previous. On May 11, 2023, INOVIO's President and Chief Executive Officer, Dr. Jacqueline Shea, commented, "From our ongoing discussions, we believe we align with the FDA on several critical design elements for our planned Phase 3 program for INO-3107."
Pennsylvania-based Inovio is a biotechnology company (NASDAQ: INO) focused on rapidly bringing to market precisely designed DNA medicines to treat, cure, and protect people from diseases associated with HPV, cancer, and infectious diseases. Inovio's DNA medicines do not interfere with or change in any way an individual's oNA.
INO-3107 Indication
RRP is rare; although benign, papillomas can cause severe, even life-threatening, airway obstruction and respiratory complications. A distinguishing aspect of this disease is the tendency for the papilloma to recur after surgical procedures to remove it. The disease is currently incurable and is mainly treated by surgery, which temporarily restores the airway, says the Company. Left untreated, if RRP develops in the lungs, affected individuals can potentially experience recurrent pneumonia, chronic lung disease (bronchiectasis), and, ultimately, progressive pulmonary failure. In rare cases, papillomas can become cancerous (malignant transformation), developing into squamous cell carcinoma.
INO-3107 News 2020 - 2023
May 11, 2023 - The Company announced additional positive data from the Phase 1/2 trial for INO-3107 in recurrent respiratory papillomatosis patients. The second cohort of the trial showed 10 of the 11 (91%) patients saw a reduction in surgical interventions in the year following initial treatment. New combined safety and immunological data showed tolerability and durable immune response presented at ABEA/COSM.
January 31, 2023 - The Company announced: "Today's announcement is a reflection of measured efforts INOVIO has undertaken to assess the portfolio and prioritize those programs with the greatest benefit for patients and commercial potential," said INOVIO's President and CEO, Dr. Jacqueline Shea. "This decision followed thoughtful consideration and thorough diligence to position the organization better and ultimately realize the potential of DNA medicines. While this is a difficult decision, I want to recognize and thank my colleagues impacted by today's news for their contributions to INOVIO and their dedication to patients worldwide."
October 13, 2022 - Dr. Ted Mau, Professor of Otolaryngology, Head and Neck Surgery at UT Southwestern Medical Center and investigator for INOVIO's RRP Phase 1/2 clinical trial said, "These preliminary results show great promise in this new therapy for patients with RRP. This is a potential game changer for our patients who have required multiple surgeries a year, especially those who have done so for many years."
November 23, 2020 - INOVIO announced it had dosed its first subject with DNA medicine INO-3107 in a Phase 1/2 clinical trial to treat RRP, a rare disease caused by HPV types 6 and 11 infections. Earlier this year, the US FDA granted INO-3107 Orphan Drug Designation.
July 29, 2020 - INOVIO today announced that the U.S. FDA granted orphan drug designation for INO-3107, its DNA medicine being evaluated in a Phase 1/2 trial to treat recurrent respiratory papillomatosis.
February 10, 2020 - Inovio Pharmaceuticals, Inc. announced the U.S. FDA had accepted its Investigational New Drug application to evaluate its DNA medicine INO-3107 in a Phase 1/2 trial for the treatment of Recurrent Respiratory Papillomatosis.
INO-3107 Recurrent Respiratory Papillomatosis (RRP) Clinical Trials
Clinical Trial NCT04398433: INO-3107 was evaluated in a Phase 1/2 open-label, multicenter trial to assess its safety, tolerability, immunogenicity, and efficacy in 32 participants with HPV 6 and/or HPV 11-associated RRP. The trial demonstrated statistical significance based on the clinical endpoint of a reduction in the number of RRP surgical interventions following the administration of INO-3107 compared with the year before treatment in the initial cohort of 21 participants. The trial had a median decrease of 3 surgical interventions (95% confidence interval 1, 3). In addition, 16 of 21 (76%) participants showed a reduction in surgical interventions in the year following the administration of INO-3107 relative to the number of surgeries before the trial. Of the 16 participants, six (6) required no surgical intervention during the trial period.
In the trial, treatment with INO-3107 induced cellular responses against both HPV 6 and HPV 11, inducing both CD4 and CD8 T cells. In addition, all 21 participants demonstrated increased peripheral T cells to one or more antigens in INO-3107 post-baseline. T-cell responses against HPV 6 and HPV 11 were also still observed at Week 52, which was 43 weeks after treatment with INO-3107, indicating a persistent cellular memory response.