News
August 28, 2025
INOVIO Advances FDA Submission for INO-3107 in Rare Disease Treatment
PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that the U.S. Food and Drug Administration has agreed to the company’s rolling submission timeline for its Biologics License Application (BLA) for ...
INO-3107, an investigational DNA medicine, to treat recurrent respiratory papillomatosis (RRP). RRP is a rare disease caused by human papillomavirus (HPV) types 6 or 11.
INOVIO Pharmaceuticals, a biotechnology company focused on developing DNA medicines, has taken a significant step forward in its efforts to bring a new treatment option to patients suffering from Recurrent Respiratory Papillomatosis (RRP), a rare and debilitating disease. The company announced today that the U.S. Food and Drug Administration (FDA) has agreed to a rolling submission timeline for its Biologics License Application (BLA) for INO-3107, their investigational DNA medicine specifically designed to combat RRP.
This agreement for a rolling submission is a crucial development, allowing INOVIO to submit sections of its BLA to the FDA as they are completed, rather than waiting until all data is finalized. This process can potentially expedite the review timeline and bring INO-3107 to patients faster.
RRP is a rare and chronic disease caused by the human papillomavirus (HPV), specifically types 6 and 11. The virus causes benign tumors, called papillomas, to grow in the respiratory tract, most commonly in the larynx (voice box). These papillomas can obstruct the airway, leading to breathing difficulties, hoarseness, and even life-threatening complications. Current treatment options primarily involve surgical removal of the papillomas, which often need to be repeated frequently as the tumors tend to recur. This constant cycle of surgery can be physically and emotionally draining for patients, particularly children who are often diagnosed with the condition.
INO-3107 represents a promising new approach to managing RRP. As a DNA medicine, it is designed to stimulate the patient's own immune system to recognize and clear the HPV infection, potentially reducing the need for repeated surgeries and improving long-term outcomes. The company believes that INO-3107 has the potential to address the underlying cause of the disease, rather than just treating the symptoms.
The agreement with the FDA marks a significant milestone for INOVIO and offers hope for individuals and families affected by RRP. While the BLA submission process is ongoing, this agreement represents a critical step towards potentially making INO-3107 available as a new treatment option for this challenging and rare disease. The company will continue to work closely
INOVIO Pharmaceuticals, a biotechnology company focused on developing DNA medicines, has taken a significant step forward in its efforts to bring a new treatment option to patients suffering from Recurrent Respiratory Papillomatosis (RRP), a rare and debilitating disease. The company announced today that the U.S. Food and Drug Administration (FDA) has agreed to a rolling submission timeline for its Biologics License Application (BLA) for INO-3107, their investigational DNA medicine specifically designed to combat RRP.
This agreement for a rolling submission is a crucial development, allowing INOVIO to submit sections of its BLA to the FDA as they are completed, rather than waiting until all data is finalized. This process can potentially expedite the review timeline and bring INO-3107 to patients faster.
RRP is a rare and chronic disease caused by the human papillomavirus (HPV), specifically types 6 and 11. The virus causes benign tumors, called papillomas, to grow in the respiratory tract, most commonly in the larynx (voice box). These papillomas can obstruct the airway, leading to breathing difficulties, hoarseness, and even life-threatening complications. Current treatment options primarily involve surgical removal of the papillomas, which often need to be repeated frequently as the tumors tend to recur. This constant cycle of surgery can be physically and emotionally draining for patients, particularly children who are often diagnosed with the condition.
INO-3107 represents a promising new approach to managing RRP. As a DNA medicine, it is designed to stimulate the patient's own immune system to recognize and clear the HPV infection, potentially reducing the need for repeated surgeries and improving long-term outcomes. The company believes that INO-3107 has the potential to address the underlying cause of the disease, rather than just treating the symptoms.
The agreement with the FDA marks a significant milestone for INOVIO and offers hope for individuals and families affected by RRP. While the BLA submission process is ongoing, this agreement represents a critical step towards potentially making INO-3107 available as a new treatment option for this challenging and rare disease. The company will continue to work closely
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