INOVIO (INO), a pioneering biotechnology company specializing in DNA medicines, has achieved a significant milestone in the development of a groundbreaking therapy. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INO-3107, a potential treatment for Recurrent Respiratory Papillomatosis (RRP). This designation is a testament to the promising clinical evidence indicating the drug's potential to substantially improve the lives of RRP patients.

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Recognition of Promise

INO-3107, a first-in-class DNA medicine candidate, has garnered attention for its potential to revolutionize the treatment of RRP. Dr. Jacqueline Shea, President and CEO of INOVIO, expressed enthusiasm about the Breakthrough Therapy designation, stating, "This is yet another important step for INO-3107 and recognition that this first-in-class DNA medicine candidate has the potential to improve the lives of patients with RRP." She further emphasized INOVIO's commitment to working closely with the FDA to accelerate the drug's development and approval, ultimately fulfilling the promise of DNA medicine in treating RRP patients.

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Hope for RRP Patients

The President of the Recurrent Respiratory Papillomatosis Foundation, Kim McClellan, also welcomed the news, saying, "RRP patients will tell you that even one reduction in the number of disruptive, invasive surgeries they face would be life-changing. The potential impact of this treatment gives me great hope for the future and I'm happy to see that RRP is finally getting the attention it deserves." This designation offers renewed hope to RRP patients who have long sought more effective and less invasive treatment options.

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A Targeted Approach

INO-3107 represents an innovative approach to combating RRP. It is an investigational DNA medicine designed to stimulate a targeted T cell response against HPV-6 and HPV-11, the specific HPV types responsible for RRP and other HPV-related diseases. The Breakthrough Therapy designation follows previous recognitions, including Orphan Drug designations from the European Commission in May 2023 and from the FDA in 2020.

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Next Steps and Partnerships

INOVIO is poised to take the next significant step in advancing INO-3107. The company plans to initiate a pivotal trial of INO-3107 in the first quarter of 2024, pending FDA clearance. To support its development efforts, INOVIO has engaged a leading Clinical Research Organization, as well as key opinion leaders and investigators, who share the vision of offering a new treatment option for RRP patients.

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Strong Clinical Evidence

The FDA's decision to grant Breakthrough Therapy designation is backed by robust data from INOVIO's Phase 1/2 open-label, multicenter trial, which evaluated the safety, tolerability, immunogenicity, and efficacy of INO-3107 in HPV-6 and/or HPV-11-related RRP patients. The trial revealed that a significant percentage of patients experienced a decrease in surgical interventions after receiving INO-3107, marking a notable breakthrough in RRP treatment.

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Sharing Promising Results

INOVIO is actively sharing the promising results of its Phase 1/2 trial. Data from this trial has been presented at prestigious scientific and medical conferences, including the 2023 Annual Meeting of the American Broncho-Esophageal Association (ABEA) and the European Laryngological Association's Annual Meeting. Moreover, these findings were published in May in the peer-reviewed journal, The Laryngoscope, under the title "Interim Results of a Phase 1/2 Open-Label Study of INO-3107 for HPV-6 and/or HPV-11–Associated RRP."

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INOVIO's Breakthrough Therapy designation for INO-3107 brings new hope to RRP patients and signifies a significant step forward in the quest for more effective treatments for this challenging condition. As the company continues to collaborate with regulatory agencies and experts, the future of RRP treatment appears increasingly promising.