FDA Sets 2026 Deadline for INOVIO’s Rare Disease Treatment
INOVIO Announces FDA Acceptance of Biologics License Application for INO-3107
PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that the U.S. Food and Drug Administration has accepted its Biologics License Application (BLA) for INO-3107, a potential non-surgical treatment for adults with recurrent respiratory papillomatosis (RRP). The application is set to be reviewed by the FDA with an action date of October 30, 2026.
The FDA classified the submission for a standard review under the Prescription Drug User Fee Act timeline and indicated it is not currently planning to convene an advisory committee to review the application. INO-3107 has been filed under the accelerated approval pathway, although the agency raised preliminary concerns about whether the company has provided sufficient justification for eligibility under this route.
INOVIO stated that it plans to seek a meeting with the FDA to discuss next steps in order to remain within the accelerated approval program. The company is not pursuing approval through the traditional pathway at this time.
“We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease and that every RRP patient deserves access to a non-surgical treatment option that can work for them,” said Dr. Jacqueline Shea, INOVIO’s president and chief executive officer. She emphasized that clinical trial data showed INO-3107 could expand treatment options based on its mechanism of action, tolerability, and a patient-focused regimen that does not require additional surgeries during dosing. “Every surgery matters to patients, and we look forward to continuing to collaborate with the FDA during the BLA review cycle,” Shea added.
Clinical Trial Data Supports Potential of INO-3107
The BLA is supported by data from a Phase 1/2 trial involving adult RRP patients who had undergone at least two surgeries in the year before treatment. Long-term follow-up data from a retrospective study of trial participants were also included, showing sustained clinical benefit during a second year without additional dosing. These findings were published in Nature Communications and The Laryngoscope.
RRP is a rare and often debilitating disease caused primarily by HPV-6 and HPV-11, marked by recurring papillomas in the respiratory tract that can obstruct airways and significantly impair speech. Surgery remains the standard of care, but lesions frequently return, requiring repeated procedures that carry risks to vocal cord function and quality of life.
INO-3107 is an investigational DNA medicine designed to trigger targeted T-cell responses against HPV-6 and HPV-11. In the Phase 1/2 trial, 72 percent of patients experienced a 50 to 100 percent reduction in surgeries after one year of treatment. In a second-year retrospective analysis, that figure increased to 86 percent, with half of patients requiring no surgeries at all. The therapy was generally well tolerated, with mostly mild side effects reported.
Regulatory Designations and Platform Advantages
The FDA has granted INO-3107 Orphan Drug and Breakthrough Therapy designations. Regulatory incentives have also been awarded in Europe and the United Kingdom, where the treatment received Orphan Drug designation and an Innovation Passport, respectively.
INOVIO said its DNA medicines platform, paired with its proprietary CELLECTRA delivery device, is designed to generate durable immune responses without the limitations associated with viral vectors. As the FDA review proceeds, the company is positioning INO-3107 as a potential first-in-class, non-surgical option for patients facing a chronic and recurrent disease with limited treatment choices.
Key Benefits of INO-3107
- Non-Surgical Option: Offers a treatment alternative that avoids the risks and complications of repeated surgeries.
- Mechanism of Action: Designed to stimulate targeted immune responses against HPV-6 and HPV-11.
- Tolerability: Demonstrated a favorable safety profile with mostly mild side effects.
- Clinical Efficacy: Showed significant reductions in the number of required surgeries over a two-year period.
Future Steps and Collaborations
INOVIO is actively working with the FDA to address any concerns and ensure that INO-3107 meets all regulatory requirements. The company remains committed to advancing this potential treatment for RRP, which affects a small but underserved patient population.
With the continued support of clinical data and regulatory designations, INO-3107 represents a promising advancement in the treatment of a rare and challenging condition. The outcome of the FDA review will be closely watched by the medical community and patients alike, as it could mark a significant step forward in managing RRP.
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