INOVIO Pharmaceuticals has announced positive preliminary results from the second cohort of its phase 1/2 clinical trial evaluating INO-3107 for the treatment of HPV 6 and HPV 11-associated recurrent respiratory papillomatosis (RRP) in adults.
In the second cohort of 11 patients who were administered INO-3107 via the exploratory side port needle, 10 of the 11 patients (91%) saw a reduction in surgical interventions in the year following initial treatment, with measurement beginning at Day 0, the start of trial therapy.
Of these 10 patients, four did not require surgery. There was a statistically significant median decrease of three surgical interventions when comparing the year following treatment to the year prior. In the year prior to treatment, the number of surgical interventions for these 11 patients ranged between two and eight, and the median was five.
INOVIO Pharmaceuticals’ INO-3107 was well-tolerated and immunogenic among patients in the second cohort. The safety and efficacy results for the second cohort were consistent with results announced for the first cohort in October 2022.
“These results from the second cohort confirm previous data that show INO-3107 is well-tolerated, immunogenic and has the potential to improve patients’ lives by reducing the need for painful surgery,” said Jeffrey Skolnik, INOVIO Pharmaceuticals’ senior vice president of clinical development.
“We will continue to engage with regulators regarding our development plans for INO-3107 and look forward to publishing and presenting our findings from the complete data set soon.”
“Many patients with RRP need years of repeated surgeries with no end in sight,” said Ted Mau, principal investigator and laryngologist at University of Texas Southwestern Medical Center.
“A treatment that results in fewer surgeries – or even no surgery – would be transformational for patients and their families.”
“We are pleased with the results from the second cohort, which are consistent with the positive data from the first cohort,” said INOVIO Pharmaceuticals’ president and chief executive officer, Jacqueline Shea.
“We are focused on advancing our most promising candidates and achieving our broader strategic vision of delivering on the potential of DNA medicines for patients.”
RRP is a debilitating and rare disease caused primarily by HPV 6 and/or HPV 11. RRP is characterized by the development of small, wart-like growths, or papillomas, in the respiratory tract. While papillomas are generally benign, they can cause severe, life-threatening airway obstruction and respiratory complications. RRP can also significantly affect quality of life for patients by affecting the voice box, limiting the ability to speak effectively. Surgery to remove papillomas is the standard of care for RRP; however, the papillomas often grow back because the underlying HPV infection has not been eradicated.
The incidence of RRP is estimated to be 4.3 cases per 100,000 children and 1.8 cases per 100,000 adults. RRP is often a life-long disease, with patients undergoing numerous surgeries during their lifetimes to control their RRP.
About INOVIO Pharmaceuticals’ INO-3107
INO-3107 is INOVIO Pharmaceuticals’ clinical-stage DNA medicine product candidate being developed as a potential treatment for RRP. INO-3107 is designed to elicit a targeted T cell response against HPV 6 and HPV 11, the HPV types responsible for causing RRP among other HPV-associated diseases.
These targeted T cells are designed to seek out and kill infected cells, with the aim of regression of existing papillomas and clearance or reduction of the levels of the virus to potentially prevent or slow the growth of new papillomas. INO-3107 received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in July 2020.