INOVIO's DNA drug INO-3107 for the treatment of the rare disease RRP was qualified by the FDA for orphan drug.

Guide: The drug is currently being evaluated in a Phase 1/2 clinical trial for the treatment of recurrent respiratory papillomadisease (RRP).
INOVIO (NASDAQ: INO) today announced that the U.S. Food and Drug Administration (FDA) has granted its DNA drug INO-3107, which is currently being evaluated in a Phase 1/2 clinical trial for the treatment of recurrent respiratory papillomavirus (RRP).
RRP is a rare disease caused by human papillomavirus (HPV) type 6 and type 11 infections.
RRP can lead to the growth of non-cancerous tumors, causing life-threatening airway obstruction sand, and occasionally worsening into cancer.
, the disease is incurable, mainly through surgery to remove the tumor to temporarily restore the airways.
tumors are prone to recurrence and may require multiple surgeries in a year.
RRP can seriously affect the quality of life of patients.
orphan drug qualification is designed to facilitate drug development for rare diseases.
FDA only grants drug orphans qualified for treatment, diagnosis, or treatment of rare diseases.
in the United States, "orphan disease" refers to a disease in which fewer than 200,000 people suffer from the disease.
the FDA's eligibility status for this orphan drug entitles INO-3107 to a variety of development incentives, including tax credits for clinical research expenditures, exemption from new drug application (NDA) fees, FDA-awarded research grants, and, most importantly, a seven-year u.S. market exclusive period after the approval of RRP treatment. "Ino-3107's eligibility for FDA Orphan Medicine is an important milestone in INOVIO's development of DNA drugs for this rare disease, and clearly emphasizes the importance of addressing unmet medical needs to address this debilitating condition," said Ami Shah Brown, Senior Vice President, M.D., M.D.,
INOVIO.
"open label, multicenter INO-31071/2 trial, which is currently open to recruit patients, will recruit approximately 63 patients in the United States to assess the efficacy, safety, tolerance and immunogenicity of INO-3107 in HPV6 and/or 11-related RRP patients who have required at least two surgeries per year for the past three years to remove related papillomas.
in the study, adult patients will first undergo surgery to remove papillomas, then use four doses of INO-3107 every three weeks.
the main therapeutic endpoint was double or longer between the first dose of INO-3107 surgery intervention than the frequency before the study.
last year, INOVIO published data from its INO-3106 clinical trial study in the scientific journal Vaccines," published by MDPI, a multidisciplinary digital publishing agency.
results show that INO-3106 produces immunogenicity, participates in and amplifies HPV6-specific cell response, including cytotoxic T cells.
article also points out that Inovio's immunotherapy has significantly reduced the need for surgery for two patients who need to undergo about two operations a year in order to control the condition.
one patient had not had surgery for more than a year and a half (584 days) and the other had been in surgery for more than two-and-a-half years (915 days).
.