INOVIO Announces New Data at Scientific Conferences for Lead Candidate, INO-3107, as a Potential Treatment for RRP
INOVIO (NASDAQ:INO) presented new data for its lead candidate, INO-3107, at scientific conferences. The company is preparing a Biologics License Application for targeted submission in mid-2025 under the FDA's Accelerated Approval Pathway Program. New immunology data showed INO-3107's ability to induce antigen-specific T cell responses against HPV-6 and HPV-11 and drive T cell recruitment into airway tissues and papilloma of RRP patients.
In the Phase 1/2 trial, INO-3107 was well-tolerated and immunogenic. 81% of patients experienced a decrease in surgical interventions post-treatment compared to baseline. The overall clinical response was 81%, with 28% of patients requiring no surgical intervention during or after the dosing window. 44% of patients had a partial response, resulting in an overall response rate of 72%.
INO-3107 induced durable cellular responses and generated T cells against HPV-6 and HPV-11. The company believes these data demonstrate INO-3107's potential to significantly improve the lives of RRP patients.
INOVIO (NASDAQ:INO) ha presentato nuovi dati per il suo candidato principale, INO-3107, in conferenze scientifiche. L'azienda si sta preparando per presentare una Domanda di Licenza Biologica con invio previsto per metà 2025 nell'ambito del Programma di Approvazione Accelerata della FDA. Nuovi dati di immunologia hanno mostrato la capacità di INO-3107 di indurre risposte delle cellule T specifiche per antigene contro HPV-6 e HPV-11 e di guidare il reclutamento delle cellule T nei tessuti delle vie aeree e nei papillomi dei pazienti con RRP.
Nella sperimentazione di Fase 1/2, INO-3107 è stata ben tollerata e immunogenica. 81% dei pazienti ha sperimentato una riduzione degli interventi chirurgici post-trattamento rispetto al basale. La risposta clinica complessiva è stata dell'81%, con il 28% dei pazienti che non ha necessitato di intervento chirurgico durante o dopo la finestra di somministrazione. Il 44% dei pazienti ha avuto una risposta parziale, con un tasso di risposta complessivo del 72%.
INO-3107 ha indotto risposte cellulari durevoli e ha generato cellule T contro HPV-6 e HPV-11. L'azienda ritiene che questi dati dimostrino il potenziale di INO-3107 di migliorare significativamente la vita dei pazienti con RRP.
INOVIO (NASDAQ:INO) presentó nuevos datos sobre su candidato principal, INO-3107, en conferencias científicas. La compañía se está preparando para someter una Solicitud de Licencia Biológica con un envío previsto para mediados de 2025 bajo el Programa de Vía de Aprobación Acelerada de la FDA. Nuevos datos de inmunología mostraron la capacidad de INO-3107 para inducir respuestas de células T específicas contra los antígenos HPV-6 y HPV-11, y para impulsar el reclutamiento de células T en los tejidos de las vías respiratorias y en los papilomas de los pacientes con RRP.
En el ensayo de Fase 1/2, INO-3107 fue bien tolerado e inmunogénico. El 81% de los pacientes experimentaron una disminución en las intervenciones quirúrgicas después del tratamiento en comparación con la línea base. La respuesta clínica general fue del 81%, con el 28% de los pacientes que no requirieron intervención quirúrgica durante o después de la ventana de dosificación. El 44% de los pacientes mostró una respuesta parcial, resultando en una tasa de respuesta general del 72%.
INO-3107 indujo respuestas celulares duraderas y generó células T contra HPV-6 y HPV-11. La compañía cree que estos datos demuestran el potencial de INO-3107 para mejorar significativamente la vida de los pacientes con RRP.
INOVIO (NASDAQ:INO)는 과학 회의에서 주요 후보인 INO-3107에 대한 새로운 데이터를 발표했습니다. 이 회사는 FDA의 가속 승인 경로 프로그램에 따라 2025년 중반에 제출될 생물학적 제품 허가 신청을 준비하고 있습니다. 새로운 면역학 데이터는 INO-3107이 HPV-6 및 HPV-11에 대한 항원 특이적 T세포 반응을 유도하고 RRP 환자의 기도 조직 및 유두종으로 T세포 모집을 유도할 수 있는 능력을 보여줍니다.
1/2상 시험에서 INO-3107은 잘 견디며 면역 반응을 나타냈습니다. 81%의 환자가 치료 후 수술 개입이 감소한 것으로 나타났으며, 이는 기초선에 비해 변화가 있었습니다. 전체적인 임상 반응은 81%였으며, 28%의 환자가 투여 기간 동안 또는 이후에 수술 개입이 필요하지 않았습니다. 44%의 환자가 부분 반응을 보여 전체 반응률은 72%에 달했습니다.
INO-3107은 지속적인 세포 반응을 유도하고 HPV-6 및 HPV-11에 대한 T세포를 생성했습니다. 회사는 이 데이터가 INO-3107이 RRP 환자의 삶을 크게 향상시킬 잠재력이 있음을 보여준다고 믿고 있습니다.
INOVIO (NASDAQ:INO) a présenté de nouvelles données concernant son principal candidat, INO-3107, lors de conférences scientifiques. L'entreprise se prépare à soumettre une Demande de Licence Biologique prévue pour le milieu de 2025 dans le cadre du Programme d'Approbation Accélérée de la FDA. De nouvelles données en immunologie ont montré la capacité d'INO-3107 à induire des réponses spécifiques des cellules T contre le HPV-6 et le HPV-11 et à favoriser le recrutement de cellules T dans les tissus des voies respiratoires et les papillomes des patients atteints de RRP.
Dans l'essai de Phase 1/2, INO-3107 a été bien toléré et immunogène. 81% des patients ont connu une réduction des interventions chirurgicales après traitement par rapport à la ligne de base. La réponse clinique globale était de 81%, avec 28% des patients ne nécessitant aucune intervention chirurgicale pendant ou après la période d'administration. 44% des patients ont eu une réponse partielle, résultant en un taux de réponse global de 72%.
INO-3107 a induit des réponses cellulaires durables et a généré des cellules T contre le HPV-6 et le HPV-11. L'entreprise estime que ces données démontrent le potentiel d'INO-3107 à améliorer considérablement la vie des patients atteints de RRP.
INOVIO (NASDAQ:INO) hat auf wissenschaftlichen Konferenzen neue Daten zu seinem Hauptkandidaten, INO-3107, präsentiert. Das Unternehmen bereitet sich darauf vor, im Rahmen des beschleunigten Zulassungsverfahrens der FDA Mitte 2025 einen Antrag auf biologisches Produktzulassung einzureichen. Neue immunologische Daten zeigten die Fähigkeit von INO-3107, antigen-spezifische T-Zell-Reaktionen gegen HPV-6 und HPV-11 auszulösen und T-Zell-Rekrutierung in das Atemweggewebe und in Papillome bei RRP-Patienten zu fördern.
Im Phase-1/2-Studie wurde INO-3107 gut vertragen und immunogen. 81% der Patienten erlebten eine Verringerung der chirurgischen Eingriffe nach der Behandlung im Vergleich zur Ausgangswert. Die gesamte klinische Antwort lag bei 81%, wobei 28% der Patienten während oder nach dem Dosierungszeitraum keine chirurgische Intervention benötigten. 44% der Patienten hatten eine partielle Antwort, was zu einer Gesamtansprechrate von 72% führte.
INO-3107 induzierte nachhaltige zelluläre Reaktionen und erzeugte T-Zellen gegen HPV-6 und HPV-11. Das Unternehmen glaubt, dass diese Daten das Potenzial von INO-3107 zeigen, das Leben von RRP-Patienten erheblich zu verbessern.
- 81% of patients required fewer surgical interventions post-treatment compared to baseline
- 28% of patients required no surgical intervention during or after dosing
- Overall response rate (ORR) of 72% in the Phase 1/2 trial
- INO-3107 was well-tolerated and immunogenic in the 32 enrolled patients
- Modified Derkay-Pransky severity scores improved from baseline to the end of 52-week trial
- 41% of patients reported a treatment-related Adverse Event (AE)
- Most frequent treatment-related AEs were injection site pain (31%) and fatigue (9%)
Insights
The new data presented for INO-3107 in treating Recurrent Respiratory Papillomatosis (RRP) is promising. Key findings include:
- Efficacy:
81% of patients required fewer surgeries post-treatment, with28% needing no interventions. - Immunogenicity: INO-3107 induced antigen-specific T cell responses against HPV-6 and HPV-11, important for targeting infected cells.
- Safety: Well-tolerated with no treatment-related adverse events above Grade 2.
- Mechanism of action: Evidence of T cell infiltration into airway tissue, correlating with clinical response.
These results suggest INO-3107 could potentially become a significant treatment option for RRP, addressing an unmet medical need. The planned BLA submission in mid-2025 under the Accelerated Approval Pathway indicates confidence in the data. However, investors should note that regulatory approval is not guaranteed and market adoption would depend on further clinical validation and competitive landscape.
This news is significant for INOVIO and the broader biotech sector focused on HPV-related diseases. Key points for investors:
- Market potential: RRP is a rare disease, but INO-3107 could become a first-in-class treatment, potentially commanding premium pricing.
- Pipeline progress: Success with INO-3107 validates INOVIO's DNA medicine platform, which could have implications for other pipeline candidates.
- Regulatory strategy: The Accelerated Approval Pathway could expedite market entry, but may require post-approval studies.
- Financial impact: While specific revenue projections aren't provided, a successful launch could significantly boost INOVIO's financial position.
Given INOVIO's current market cap of
- American Association for Cancer Research (AACR) Special Conference: Tumor Immunology and Immunotherapy: New immunology data showed ability of INO-3107 to induce an antigen-specific T cell response against HPV-6 and HPV-11 and drive recruitment of T cells into airway tissues and papilloma
- International Society of Vaccines Conference: Full safety and efficacy data from Phase 1/2 clinical study in patients with Recurrent Respiratory Papillomatosis (RRP) indicated that INO-3107 was well tolerated and immunogenic;
81% of patients in the trial required fewer surgeries post-treatment when compared to baseline
At AACR's Tumor and Immunology Conference on October 19, INOVIO presented new immunology data demonstrating the ability of INO-3107 to induce antigen-specific T cell responses against HPV-6 and HPV-11 and drive recruitment of those T cells into airway tissues and papilloma of RRP patients, which could ultimately slow or eliminate papilloma regrowth. Additionally, INOVIO will tomorrow present its full safety and efficacy data set for the Phase 1/2 trial for INO-3107 at the International Society of Vaccines Conference. In the trial, INO-3107 was found to be well tolerated and immunogenic. Of the 32 patients in the trial, 26 patients, or
"The new immunology data support the proposed mechanism of action of INO-3107 which is to generate an immune response that can seek out and eliminate HPV-6 and HPV-11 infected cells that are the underlying cause of papilloma growth," said Dr. Matthew Morrow, INOVIO's Vice President of Translational Science. "Our analysis shows that INO-3107 induced significant clonal T cell expansion in the blood, including antigen-specific killer T cells. Investigators also observed T cell infiltration into airway tissue, which is positively associated with clinical response."
"The collective story these data sets provide is compelling. Over
Summary of Data Presented at Conferences
AACR Special Conference in Cancer Research: Tumor Immunology and Immunotherapy
Abstract: Reduction in Surgical Interventions for the Treatment of Recurrent Respiratory Papillomatosis by INO-3107 is Associated with Enriched Macrophage, Dendritic cell and T cell Signatures in Patient Airways
New Immunology data for INO-3107 demonstrated:
- Induction of T cell responses specifically for HPV-6 and HPV-11
- Expansion of antigen specific, clonal T cell populations in peripheral blood
- Induction of inflammatory responses in papilloma and airway tissue, including:
- Interferon, cytokine and chemokine signaling
- Adaptive and innate immune cell infiltration, with emphasis on T cells
- Cytotoxic signatures of infiltrated T cells in papilloma/airway tissue, providing direct evidence of increased overall T cell infiltration compared to pre-treatment
- Clinical activity not impacted by immunosuppressive papilloma microenvironment
International Society of Vaccines Conference
Abstract: Clinical Assessment of Adjuvant Immunotherapy, INO-3107, in Adult Patients with Recurrent respiratory papillomatosis (RRP)
Clinical Results of Phase 1/2 Study with INO-3107 in Adult RRP Patients
In the trial, the overall clinical response (OCR) was
Other key data points presented include:
- INO-3107 was well tolerated and immunogenic in the 32 patients enrolled
41% (13/32) of patients reported a treatment-related Adverse Event (AE)- Most frequent treatment-related AE's reported were injection site pain (
31% ) and fatigue (9% ) - No treatment-related AEs greater than Grade 2 severity were reported
- Modified Derkay-Pransky severity scores improved from baseline to the end of 52-week trial
- INO-3107 induced durable cellular responses and generated T cells against HPV-6 and HPV-11
The abstracts from the poster and presentations are available on the INOVIO events page: [tbd link]
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 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. The most widely cited
About INO-3107
INO-3107 is a DNA immunotherapy designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. These targeted T cells are designed to 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 clinical trial conducted with INO-3107,
The FDA granted INO-3107 Orphan Drug designation and Breakthrough Therapy designation, and advised INOVIO that it could submit its BLA under the accelerated approval program using data from its already completed Phase 1/2 trial. The European Commission granted INO-3107 Orphan Drug designation and assigned INOVIO's delivery device CELLECTRA® a CE marking, a regulatory standard that certifies that a product has met European Union's safety, health, and environmental standards. 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® 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 www.inovio.com.
Contacts
Media: Jennie Willson (267) 429-8567 jennie.willson@inovio.com
Investors: Thomas Hong (267) 440-4298 thomas.hong@inovio.com
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SOURCE INOVIO Pharmaceuticals, Inc.
FAQ
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