Data Published in The Laryngoscope shows INO-3107 Resulted in Long-Term Surgery Reduction in Recurrent Respiratory Papillomatosis (RRP)
INOVIO (NASDAQ: INO) published promising long-term data in The Laryngoscope for its DNA medicine INO-3107 in treating Recurrent Respiratory Papillomatosis (RRP). The retrospective study showed significant improvements in patient outcomes, with the Overall Response Rate increasing to 86% in Year 2 from 72% in Year 1, and Complete Response rate rising to 50% from 28%.
The mean number of required surgeries decreased substantially from 4.1 per year pre-treatment to 1.7 in Year 1 and 0.9 in Year 2. The study followed 28 patients with a median follow-up of 2.8 years, demonstrating continued improvement trends into Year 3. Importantly, INO-3107 was well-tolerated with no serious adverse events reported.
INOVIO (NASDAQ: INO) ha pubblicato su The Laryngoscope dati a lungo termine promettenti sul suo medicinale a DNA INO-3107 per il trattamento della Papillomatosi respiratoria ricorrente (RRP). Lo studio retrospettivo ha mostrato miglioramenti significativi negli esiti dei pazienti, con il tasso di risposta globale salito all'86% nel secondo anno dal 72% del primo e la percentuale di risposta completa aumentata al 50% dal 28%.
Il numero medio di interventi chirurgici necessari 猫 diminuito sostanzialmente, passando da 4,1 all'anno prima del trattamento a 1,7 nel primo anno e 0,9 nel secondo. Lo studio ha seguito 28 pazienti con un follow-up mediano di 2,8 anni, evidenziando tendenze di miglioramento anche nel terzo anno. Importante: INO-3107 猫 stato ben tollerato e non sono stati segnalati eventi avversi gravi.
INOVIO (NASDAQ: INO) public贸 en The Laryngoscope datos prometedores a largo plazo sobre su f谩rmaco de ADN INO-3107 para el tratamiento de la Papilomatosis Respiratoria Recurrente (RRP). El estudio retrospectivo mostr贸 mejoras significativas en los resultados de los pacientes, con la tasa de respuesta global aumentando al 86% en el a帽o 2 desde el 72% en el a帽o 1 y la tasa de respuesta completa elev谩ndose al 50% desde el 28%.
El n煤mero medio de cirug铆as necesarias se redujo considerablemente, de 4.1 por a帽o antes del tratamiento a 1.7 en el a帽o 1 y 0.9 en el a帽o 2. El estudio sigui贸 a 28 pacientes con un seguimiento medio de 2.8 a帽os, mostrando tendencias de mejora continuas hasta el a帽o 3. Importante: INO-3107 fue bien tolerado y no se informaron eventos adversos graves.
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INOVIO (NASDAQ: INO) a publi茅 dans The Laryngoscope des donn茅es 脿 long terme prometteuses concernant son m茅dicament 脿 ADN INO-3107 pour le traitement de la papillomatose respiratoire r茅currente (RRP). L'茅tude r茅trospective a montr茅 des am茅liorations significatives des r茅sultats cliniques, avec le taux de r茅ponse global passant 脿 86% la deuxi猫me ann茅e contre 72% la premi猫re et le taux de r茅ponse compl猫te augmentant 脿 50% contre 28%.
Le nombre moyen d'interventions chirurgicales n茅cessaires a diminu茅 sensiblement, de 4,1 par an avant le traitement 脿 1,7 la premi猫re ann茅e et 0,9 la deuxi猫me ann茅e. L'茅tude a suivi 28 patients avec un suivi m茅dian de 2,8 ans, montrant des tendances d'am茅lioration se poursuivant jusqu'脿 la troisi猫me ann茅e. Fait important : INO-3107 a 茅t茅 bien tol茅r茅 et aucun 茅v茅nement ind茅sirable grave n'a 茅t茅 signal茅.
INOVIO (NASDAQ: INO) ver枚ffentlichte in The Laryngoscope vielversprechende Langzeitdaten zu seinem DNA-Medikament INO-3107 zur Behandlung der rezidivierenden respiratorischen Papillomatose (RRP). Die retrospektive Studie zeigte deutliche Verbesserungen der Patientenergebnisse: die Gesamtansprechrate stieg im zweiten Jahr von 72% auf 86% und die komplette Ansprechrate erh枚hte sich von 28% auf 50%.
Die durchschnittlich erforderliche Anzahl von Operationen verringerte sich deutlich von 4,1 pro Jahr vor der Behandlung auf 1,7 im ersten Jahr und 0,9 im zweiten Jahr. Die Studie begleitete 28 Patienten mit einer medianen Nachbeobachtungszeit von 2,8 Jahren und zeigte anhaltende Verbesserungen bis ins dritte Jahr. Wichtig: INO-3107 wurde gut vertragen; schwerwiegende Nebenwirkungen wurden nicht berichtet.
- Overall Response Rate improved significantly to 86% in Year 2 from 72% in Year 1
- Complete Response rate nearly doubled to 50% in Year 2 from 28% in Year 1
- Mean surgeries reduced by 78% from 4.1 pre-treatment to 0.9 in Year 2
- No serious adverse events or long-term safety concerns identified
- Continued improvement trend observed into Year 3
- None.
Insights
INOVIO's INO-3107 shows increasingly positive long-term results for RRP, with surgery needs dropping 78% by year 2, suggesting strong commercial potential.
The peer-reviewed data published in The Laryngoscope provides compelling evidence of INO-3107's durable efficacy in treating Recurrent Respiratory Papillomatosis (RRP). The retrospective analysis reveals progressive improvement over time - a rare and valuable characteristic for any therapeutic. The overall response rate improved from 72% in Year 1 to 86% in Year 2, while complete responses (patients requiring zero surgeries) increased from 28% to 50%.
What's particularly significant is the continued reduction in surgical burden - from a baseline of 4.1 surgeries annually before treatment to just 0.9 surgeries by Year 2, representing a 78% reduction in surgical interventions. This trajectory appears to continue improving into Year 3 based on partial data.
For RRP patients, each surgery avoided represents meaningful clinical benefit. RRP is a debilitating condition where HPV causes recurrent growths in the respiratory tract, requiring repeated surgical removal to maintain airway patency. These frequent surgeries can lead to voice damage, psychological distress, and significant healthcare costs.
The safety profile appears favorable with no reported serious adverse events or long-term safety concerns, which is critical for a therapy targeting a chronic condition requiring long-term management.
This DNA immunotherapy represents a potential paradigm shift in RRP management, moving from purely symptomatic surgical intervention to addressing the underlying HPV infection driving the disease. The sustained and improving efficacy demonstrated here substantially strengthens INO-3107's clinical profile and commercial potential as it advances toward potential regulatory approval.
- Retrospective trial showed Overall Response Rate (ORR) improved to
86% at the end of the second 12-month period (Year 2) compared to72% observed at the end of the initial 12-month Phase 1/2 trial (Year 1); the Complete Response (CR) rate improved to50% for Year 2 from28% for Year 1 - Mean number of surgeries patients needed to control their RRP continued to drop from 4.1 surgeries per year prior to receiving INO-3107 to 1.7 for Year 1 to 0.9 for Year 2
- Partial data into the third 12-month period (Year 3 - median follow up 2.8 years following initial treatment) continued the trend of improvement and a reduced number of surgeries
"The most important takeaway from this data is that the majority of patients experienced a reduction in surgeries following initial treatment with INO-3107, and almost all of those patients maintained or improved their response 2 years after initial treatment," said Dr. Aaron Friedman, Associate Professor of Clinical Otolaryngology, Head and Neck Surgery, University of Cincinnati Medical Center, and a principal investigator on the trial. "With this continued improvement in clinical effect, we believe INO-3107 has the potential to change the trajectory of a patient's disease and set a new standard of care for the RRP community."
"Understanding how much every single surgery matters to patients, it is compelling to see the vast majority of patients experienced significant benefit from treatment with INO-3107, resulting in a reduction in the number of surgeries required to control their disease 鈥� a benefit that continued and often improved over time," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "The sustained reduction in surgery following treatment with INO-3107 demonstrated here is central to our belief that INO-3107 could become the preferred product on the market, if approved"
A Phase 1/2 open-label trial of INO-3107 (RRP-001) in 32 patients, previously published in , demonstrated a statistically significant reduction in the number of surgeries needed to control their RRP when comparing the 12 months following the initiation of treatment with INO-3107 versus the 12 months prior to beginning treatment with INO-3107. The retrospective trial published today in The Laryngoscope (RRP-02) collected data on 28 of the original 32 patients in RRP-001 to assess the longer-term treatment effect of INO-3107. The median follow-up period for both RRP-001 and RRP-002 combined was 2.8 years from treatment initiation. The efficacy assessment was defined by the number of RRP surgical interventions reported. The safety evaluation included reported serious adverse events (SAEs).
Key Results of the Retrospective Trial with INO-3107
- INO-3107 demonstrated continued clinical effect against RRP that improved over time:
- Patients experiencing a 50
-100% reduction in surgeries (ORR) increased from72% at the end of the initial 12-month Phase 1/2 trial (Year 1) to86% at the end of the second 12-month period (Year 2) - Patients experiencing a CR (0 surgeries per year) increased from
28% for Year 1 to50% for Year 2 - Mean number of surgeries was reduced from 4.1 in the pre-treatment period (the 52 weeks prior to beginning treatment with INO-3107) to 1.7 for Year 1 to 0.9 for Year 2
- Partial data into the third 12-month period (Year 3 - median follow up 2.8 years following initial treatment) continued the trend of improvement and a reduced number of surgeries
- Patients experiencing a 50
- INO-3107 was well tolerated, with no serious adverse events or long-term safety concerns identified
About RRP
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听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. INOVIO's market research to date with patients and healthcare professionals indicates that a reduction of even one surgery matters, because every surgery poses a significant risk of causing permanent damage to the vocal cords and comes with potential costs to the patient, including adverse impacts to both quality of life and finances. The most widely cited
About INO-3107
INO-3107 is an investigational DNA medicine designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. These targeted T cells seek out and kill HPV-6 and HPV-11 infected cells, with the aim of potentially preventing or slowing the growth of new papillomas. In a Phase 1/2 trial of 32 participants (RRP-001),
The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations and has advised INOVIO that it can submit a biologics license application under the FDA's accelerated approval program using data from INOVIO's completed Phase 1/2 trial. The European Commission granted INO-3107 Orphan Drug designation. In addition, INOVIO has CE-marked its CELLECTRA庐听delivery device in the EU, which allows INOVIO to commercialize the device in the EU and other geographies that recognize CE-marking. The
About INOVIO's DNA Medicines Platform
INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA听delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms.
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit听www.inovio.com.
Forward-Looking Statements
This press release contains certain forward-looking statements relating to our business, including the potential clinical benefit of INO-3107 and potential market acceptance if INO-3107 is approved Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or听allegedly听infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.
Contacts
Media: Jennie Willson, (267) 429-8567,听[email protected]
Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505,听[email protected]听
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