Inovio Receives Advanced Therapy Medicinal Product Certificate from European Medicines Agency for Quality and Non-Clinical Data for Lead Candidate INO-3107
INOVIO (NASDAQ: INO), a biotechnology company focused on DNA medicines, announced that the European Medicines Agency's Committee for Advanced Therapies (CAT) has certified the quality and non-clinical data for INO-3107, their lead candidate for treating Recurrent Respiratory Papillomatosis (RRP). This certification confirms that INOVIO's chemistry, manufacturing and controls (CMC) data and nonclinical results comply with the scientific and technical standards used for evaluating a European Marketing Authorization Application.
The CAT certification provides an opportunity to identify potential development issues before submitting a Marketing Authorization Application, particularly beneficial for small and medium-sized enterprises. This regulatory achievement validates INOVIO's efforts to bring INO-3107 to RRP patients globally and demonstrates their development team's adherence to high standards.
INOVIO (NASDAQ: INO), un'azienda biotecnologica focalizzata sui medicinali a base di DNA, ha annunciato che il Comitato per le Terapie Avanzate (CAT) dell'Agenzia Europea dei Medicinali ha certificato la qualità e i dati non clinici per INO-3107, il loro candidato principale per il trattamento della Papillomatosi Respiratoria Ricorrente (RRP). Questa certificazione conferma che i dati di chimica, produzione e controlli (CMC) e i risultati non clinici di INOVIO sono conformi agli standard scientifici e tecnici utilizzati per la valutazione di una richiesta di autorizzazione commerciale in Europa.
La certificazione del CAT offre l'opportunità di identificare potenziali problemi di sviluppo prima di presentare una richiesta di autorizzazione al commercio, particolarmente vantaggiosa per le piccole e medie imprese. Questo traguardo normativo convalida gli sforzi di INOVIO per portare INO-3107 ai pazienti affetti da RRP a livello globale e dimostra l'aderenza del loro team di sviluppo a standard elevati.
INOVIO (NASDAQ: INO), una compañía biotecnológica centrada en medicamentos basados en ADN, anunció que el Comité para Terapias Avanzadas (CAT) de la Agencia Europea de Medicamentos ha certificado la calidad y los datos no clínicos para INO-3107, su principal candidato para el tratamiento de la Papilomatosis Respiratoria Recurrente (RRP). Esta certificación confirma que los datos de química, fabricación y controles (CMC) y los resultados no clínicos de INOVIO cumplen con los estándares científicos y técnicos utilizados para evaluar una Solicitud de Autorización de Comercialización en Europa.
La certificación del CAT proporciona una oportunidad para identificar problemas potenciales de desarrollo antes de presentar una Solicitud de Autorización de Comercialización, lo que resulta particularmente beneficioso para las pequeñas y medianas empresas. Este logro regulatorio valida los esfuerzos de INOVIO para llevar INO-3107 a los pacientes con RRP a nivel mundial y demuestra la adherencia de su equipo de desarrollo a altos estándares.
INOVIO (NASDAQ: INO)는 DNA 의약품에 집중하는 바이오 제약 회사로, 유럽 의약품청의 첨단 치료위원회(CAT)가 INO-3107에 대한 품질 및 비임상 데이터를 인증했다고 발표했습니다. INO-3107은 재발성 호흡기 유두종증(RRP) 치료를 위한 주요 후보입니다. 이 인증은 INOVIO의 화학, 제조 및 관리(CMC) 데이터 및 비임상 결과가 유럽 마케팅 허가 신청 평가에 사용되는 과학적 및 기술적 기준을 준수함을 확인합니다.
CAT 인증은 마케팅 허가 신청 제출 전에 개발 문제를 식별할 수 있는 기회를 제공하며, 이는 중소기업에 특히 유리합니다. 이 규제 성과는 INOVIO가 전 세계 RRP 환자에게 INO-3107을 제공하기 위한 노력을 검증하며, 높은 기준을 준수하는 개발팀의 노력을 보여줍니다.
INOVIO (NASDAQ: INO), une entreprise biotechnologique spécialisée dans les médicaments à base d'ADN, a annoncé que le Comité des thérapies avancées (CAT) de l'Agence européenne des médicaments a certifié la qualité et les données non cliniques pour INO-3107, leur principal candidat pour le traitement de la papillomatose respiratoire récurrente (RRP). Cette certification confirme que les données de chimie, de fabrication et de contrôle (CMC) et les résultats non cliniques d'INOVIO sont conformes aux normes scientifiques et techniques utilisées pour évaluer une demande d'autorisation de mise sur le marché en Europe.
La certification CAT offre l'opportunité d'identifier les problèmes de développement potentiels avant de soumettre une demande d'autorisation de mise sur le marché, ce qui est particulièrement bénéfique pour les petites et moyennes entreprises. Cette réalisation réglementaire valide les efforts d'INOVIO pour apporter INO-3107 aux patients RRP à l'échelle mondiale et démontre l'engagement de son équipe de développement à des normes élevées.
INOVIO (NASDAQ: INO), ein biotechnologisches Unternehmen, das sich auf DNA-Medikamente spezialisiert hat, gab bekannt, dass der Ausschuss für fortgeschrittene Therapien (CAT) der Europäischen Arzneimittel-Agentur die Qualität und die nicht-klinischen Daten für INO-3107, ihren Hauptkandidaten zur Behandlung von Recurrent Respiratory Papillomatosis (RRP), zertifiziert hat. Diese Zertifizierung bestätigt, dass die Chemie-, Herstellungs- und Kontroll- (CMC) Daten und nicht-klinische Ergebnisse von INOVIO den wissenschaftlichen und technischen Standards entsprechen, die zur Bewertung eines Antrags auf Marktzulassung in Europa verwendet werden.
Die CAT-Zertifizierung bietet die Möglichkeit, potenzielle Entwicklungsprobleme zu identifizieren, bevor ein Antrag auf Marktzulassung eingereicht wird, was für kleine und mittelständische Unternehmen besonders vorteilhaft ist. Dieser regulatorische Erfolg validiert die Bemühungen von INOVIO, INO-3107 weltweit zu RRP-Patienten zu bringen, und demonstriert die Einhaltung hoher Standards durch ihr Entwicklungsteam.
- European Medicines Agency certified quality and non-clinical data for INO-3107
- Confirmation of compliance with scientific and technical standards for European Marketing Authorization Application
- Progress in development efforts for INO-3107 in Europe
- None.
The European Medicines Agency's (EMA) Advanced Therapy Medicinal Product (ATMP) certificate for INO-3107 is a positive development for INOVIO, but its immediate impact on the company's financial prospects is This certification, while validating the quality of INOVIO's data and manufacturing processes, is primarily a regulatory milestone rather than a direct indicator of commercial success.
Key points to consider:
- The certificate confirms that INOVIO's chemistry, manufacturing and controls (CMC) data and nonclinical results meet EU standards for a potential Marketing Authorization Application.
- This achievement reduces regulatory risk and potentially streamlines future approval processes in Europe.
- However, it does not guarantee market approval or commercial success for INO-3107.
- The certification is specifically valuable for small and medium-sized enterprises, helping them identify and address potential issues early in the development process.
While this news demonstrates progress in INOVIO's regulatory strategy, investors should remain cautious. The path from regulatory milestones to market success is long and uncertain, especially in the competitive biotech sector. The true value of this certification will only be realized if INO-3107 continues to show promising results in clinical trials and eventually gains market approval.
INOVIO's receipt of the ATMP certificate for INO-3107 is a positive step, but its impact on the company's market position should be viewed in context. Here's what investors should consider:
- Market Differentiation: The ATMP certification potentially sets INOVIO apart in the Recurrent Respiratory Papillomatosis (RRP) treatment landscape. However, the RRP market is relatively small, which may limit the commercial potential of INO-3107.
- Pipeline Progress: This certification applies only to INO-3107, not INOVIO's entire pipeline. Investors should assess the company's overall portfolio and development progress across multiple candidates.
- Financial Implications: While regulatory milestones can boost investor confidence, they don't directly impact revenue or profitability. INOVIO's financial health and burn rate remain critical factors for consideration.
- Competitive Landscape: The ATMP certification doesn't guarantee market exclusivity. Investors should monitor competitors' progress in developing RRP treatments.
In conclusion, while this regulatory achievement is encouraging, it's just one piece of a larger puzzle. Investors should continue to monitor INOVIO's clinical trial results, cash position and overall pipeline progress to gauge the company's long-term prospects in the competitive biotech sector.
Data reviewed complies with standards that would be used to evaluate an EU Marketing Authorization Application
"This latest regulatory achievement further validates our efforts to bring INO-3107 to RRP patients around the world and shows that our cross functional development team is meeting the highest of standards in pursuit of that goal," said Cheryl Elder, INOVIO's Senior Vice President of Regulatory Affairs. "We're pleased to receive confirmation that our development efforts in
The CAT provides assessment and certification of advanced therapy medicinal products (ATMPs) under development by micro-, small- and medium-sized enterprises (SMEs), providing an important opportunity to identify any potential development issues prior to the submission of a Marketing Authorization Application.
About INO-3107
INO-3107 is 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 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 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.
Forward-Looking Statements
This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and expectations regarding our research and development programs, including timelines and prospects for regulatory approval, expectations regarding INO-3107's ability to maintain T cell response and overall efficacy, as well as benefits for patients. 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 allegedly 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, 2023, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, 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, jennie.willson@inovio.com
Investors: Thomas Hong, (267) 440-4298, thomas.hong@inovio.com
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SOURCE INOVIO Pharmaceuticals, Inc.
FAQ
What is the significance of the Advanced Therapy Medicinal Product Certificate for INOVIO's INO-3107?
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