INO-3107 Recurrent Respiratory Papillomatosis (RRP) Description
INO-3107 is a DNA medicine 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 is characterized by the growth of tumors in the respiratory tract caused by HPV.
Inovio'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.
Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses.
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.
"Inovio's investigational DNA medicine INO-3107 is designed to destroy and clear tumors caused by HPV 6 and 11 infections from the body exactly where they are hiding," said Jeffrey Skolnik, M.D., Inovio's Vice President of Clinical Development. "We believe this DNA medicine has the potential to provide people living with RRP a long-term, if not life-long, improvement in their disease, especially as an alternative to often successive and debilitating surgeries that may temporarily remove HPV growths from the airways but do not address the underlying recurring virus."
Pennsylvania Inovio is a biotechnology company 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 own DNA.
INO-3107 Recurrent Respiratory Papillomatosis (RRP) Indication
INO-3107 is a DNA medicine indicated to treat RRP that is a rare disease. 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.
RRP is a rare disease caused by the human papillomavirus (HPV) types 6 and 11 infections, a condition that causes non-cancerous tumor growths leading to life-threatening airway obstructions. The disease is currently incurable and is mostly 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 Recurrent Respiratory Papillomatosis (RRP) News
November 23, 2020 - INOVIO announced it has dosed its first subject with DNA medicine INO-3107 in a Phase 1/2 clinical trial for the treatment of RRP, a rare disease caused by the 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 for the treatment of recurrent respiratory papillomatosis.
February 10, 2020 - Inovio Pharmaceuticals, Inc. announced the U.S. FDA has 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 With Electroporation in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis. Last Update Posted: November 4, 2020.
- This is an open-label phase1/2, multi-center trial to evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in participants with HPV-6 and/or HPV-11 associated recurrent respiratory papillomatosis.
- The trial population is divided into two cohorts: Cohort A: Participants with diagnoses of Juvenile-Onset RRP as defined by age at first diagnosis of RRP < 12 years. Cohort B: Participants with Adult-onset RRP as defined by age at first diagnosis of RRP ≥ 12 years.
- A safety run-in will be performed with up to six participants across cohort A and B with a one week waiting period between each enrolled participant.