AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions
AC Immune's partner, Life Molecular Imaging (LMI), has received Fast Track Designation from the FDA for the Tau-PET diagnostic [18F]PI-2620 in three neurodegenerative conditions: Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). PI-2620, currently in Phase 3 clinical development for detecting Tau pathology in AD, is a next-generation PET imaging agent. This designation aims to accelerate development and review, highlighting the importance of early and accurate diagnoses in neurodegenerative diseases.
The Fast Track status for PI-2620 follows similar designations for AC Immune's active immunotherapies ACI-35.030 and ACI-24.060, both in Phase 2. This recognition underscores AC Immune's leadership in developing precision therapeutics for neurodegenerative diseases and its commitment to improving patient care through early diagnosis and treatment.
Il partner di AC Immune, Life Molecular Imaging (LMI), ha ricevuto la Designazione Fast Track da parte della FDA per il diagnostico Tau-PET [18F]PI-2620 in tre condizioni neurodegenerative: malattia di Alzheimer (DA), paralisi sopranucleare progressiva (PSP) e degenerazione corticobasale (CBD). PI-2620, attualmente in Sviluppo clinico di Fase 3 per la rilevazione della patologia Tau nella DA, è un agente di imaging PET di nuova generazione. Questa designazione mira ad accelerare lo sviluppo e la revisione, sottolineando l'importanza di diagnosi precoci e accurate nelle malattie neurodegenerative.
Lo stato di Fast Track per PI-2620 segue designazioni simili per le immunoterapie attive di AC Immune, ACI-35.030 e ACI-24.060, entrambe nella Fase 2. Questo riconoscimento sottolinea la leadership di AC Immune nello sviluppo di terapie di precisione per le malattie neurodegenerative e il suo impegno a migliorare la cura dei pazienti attraverso diagnosi e trattamenti precoci.
El socio de AC Immune, Life Molecular Imaging (LMI), ha recibido la Designación Fast Track de la FDA para el diagnóstico Tau-PET [18F]PI-2620 en tres condiciones neurodegenerativas: enfermedad de Alzheimer (EA), parálisis supranuclear progresiva (PSP) y degeneración corticobasal (CBD). PI-2620, actualmente en Desarrollo clínico de Fase 3 para detectar la patología tau en EA, es un agente de imagen PET de nueva generación. Esta designación tiene como objetivo acelerar el desarrollo y la revisión, destacando la importancia de diagnósticos tempranos y precisos en enfermedades neurodegenerativas.
El estado de Fast Track para PI-2620 sigue designaciones similares para las inmunoterapias activas de AC Immune, ACI-35.030 y ACI-24.060, ambas en Fase 2. Este reconocimiento subraya el liderazgo de AC Immune en el desarrollo de terapias de precisión para enfermedades neurodegenerativas y su compromiso de mejorar la atención al paciente a través de diagnósticos y tratamientos tempranos.
AC Immune의 파트너, Life Molecular Imaging (LMI)는 FDA로부터 세 가지 신경퇴행성 질환에 대한 Tau-PET 진단제 [18F]PI-2620에 대해 신속 승인 지정(Fast Track Designation)을 받았습니다: 알츠하이머병(AD), 진행성 수핵마비(PSP), 그리고 피질기저변성증(CBD). 현재 3상 임상 개발 중인 PI-2620은 AD에서 타우 병리를 탐지하기 위한 차세대 PET 이미징 제제입니다. 이 지정은 신경퇴행성 질환에서 조기 정확한 진단의 중요성을 강조하며 개발 및 검토 과정을 가속화하는 목적을 가지고 있습니다.
PI-2620의 신속 승인 상태는 AC Immune의 활성 면역요법인 ACI-35.030 및 ACI-24.060에 대한 유사한 지명 이후입니다. 이 인정은 신경퇴행성 질환을 위한 정밀 치료제 개발에서 AC Immune의 리더십과 조기 진단 및 치료를 통한 환자 치료 개선에 대한 헌신을 강조합니다.
Le partenaire d'AC Immune, Life Molecular Imaging (LMI), a reçu la Désignation Fast Track de la FDA pour le diagnostic Tau-PET [18F]PI-2620 dans trois conditions neurodégénératives : la maladie d'Alzheimer (MA), la paralysie supranucléaire progressive (PSP) et la dégénérescence corticobasale (DCB). PI-2620, actuellement en Développement clinique de Phase 3 pour détecter la pathologie Tau dans la MA, est un agent d'imagerie PET de nouvelle génération. Cette désignation vise à accélérer le développement et l'examen, mettant en avant l'importance de diagnostics précoces et précis dans les maladies neurodégénératives.
Le statut Fast Track pour PI-2620 fait suite à des désignations similaires pour les immunothérapies actives d'AC Immune, ACI-35.030 et ACI-24.060, toutes deux en Phase 2. Cette reconnaissance souligne le leadership d'AC Immune dans le développement de thérapies de précision pour les maladies neurodégénératives et son engagement à améliorer les soins aux patients grâce à un diagnostic et un traitement précoces.
Der Partner von AC Immune, Life Molecular Imaging (LMI), hat von der FDA die Fast Track Designation für das Tau-PET-Diagnosikum [18F]PI-2620 in drei neurodegenerativen Erkrankungen erhalten: Alzheimer-Krankheit (AD), progressive supranukleäre Lähmung (PSP) und kortikobasale Degeneration (CBD). PI-2620 befindet sich derzeit in der Phase-3- klinischen Entwicklung zur Erkennung von Tau-Pathologie bei AD und ist ein bildgebender PET-Agent der nächsten Generation. Diese Auszeichnung soll die Entwicklung und Überprüfung beschleunigen und hebt die Bedeutung einer frühen und genauen Diagnose von neurodegenerativen Erkrankungen hervor.
Der Status Fast Track für PI-2620 folgt ähnlichen Auszeichnungen für AC Immunes aktive Immuntherapien ACI-35.030 und ACI-24.060, beide in Phase 2. Diese Anerkennung unterstreicht die Führungsrolle von AC Immune in der Entwicklung präziser Therapeutika für neurodegenerative Erkrankungen und das Engagement zur Verbesserung der Patientenversorgung durch frühe Diagnose und Behandlung.
- Fast Track Designation received for PI-2620 in three neurodegenerative conditions
- PI-2620 is in Phase 3 clinical development for Alzheimer's disease
- Fast Track status previously granted to two other AC Immune therapies (ACI-35.030 and ACI-24.060)
- None.
Insights
The FDA's Fast Track designation for PI-2620 across three neurodegenerative conditions is a significant milestone for AC Immune and its partner LMI. This designation could accelerate the development and approval process for this Tau-PET diagnostic, potentially bringing it to market faster. The ability to accurately diagnose Alzheimer's disease, progressive supranuclear palsy and corticobasal degeneration earlier could be game-changing for patient care.
PI-2620's potential to detect Tau pathology, a hallmark of several neurodegenerative disorders, could lead to more precise diagnoses and personalized treatment strategies. This aligns with the growing trend towards precision medicine in neurodegenerative disease management. The Phase 3 status of PI-2620 in Alzheimer's disease indicates that it's in advanced stages of clinical development, which is promising for near-term commercialization prospects.
This Fast Track designation could potentially accelerate revenue generation for AC Immune if PI-2620 reaches the market sooner. The diagnostic's applicability across multiple neurodegenerative conditions expands its potential market size significantly. However, it's important to note that AC Immune is partnered with LMI for this product, which likely means shared revenues.
Investors should consider that while this news is positive, the financial impact may be in the short term. The company still needs to successfully complete Phase 3 trials and obtain regulatory approval. Additionally, the market adoption rate for new diagnostics can vary. Long-term, if PI-2620 proves successful, it could strengthen AC Immune's position in the neurodegenerative disease market and potentially lead to increased partnerships or licensing opportunities.
The Fast Track designation for PI-2620 across three conditions underscores the growing market need for accurate neurodegenerative disease diagnostics. With an aging global population, the demand for such diagnostics is likely to increase substantially. This move by the FDA also signals a shift in the regulatory landscape, recognizing the importance of early and accurate diagnosis in neurodegenerative diseases.
AC Immune's progress with PI-2620, along with its other Fast Track designated immunotherapies, positions the company as a strong player in the neurodegenerative disease market. This could attract more investor attention and potentially lead to increased collaborations with larger pharmaceutical companies. However, competition in this space is intense and AC Immune will need to maintain its innovative edge to capitalize on these opportunities fully.
AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions
- PI-2620 is in Phase 3 development in Alzheimer’s disease by AC Immune’s partner, LMI
- This Fast Track designation applies across Alzheimer’s disease, progressive supranuclear palsy, and corticobasal degeneration
- Follows two previous Fast Track designations for ACI-35.030 and ACI-24.060 active immunotherapies
- Affirms AC Immune’s leadership and commitment to bringing precision medicine to the management of neurodegenerative diseases
Lausanne, Switzerland, August 28, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today announced that its partner Life Molecular Imaging (LMI) has received Fast Track Designation for the Tau positron emission tomography (PET) diagnostic, [18F]PI-2620, from the U.S. Food and Drug Administration (FDA) in three neurodegenerative conditions.
Fast Track designation for [18F]PI-2620 has been granted for clinical development in Alzheimer’s disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).
The FDA’s Fast Track program is designed to accelerate the development and review of drugs that address serious conditions and fulfill unmet medical needs. This designation underscores the broadening view in the medical community that early and accurate diagnoses of neurodegenerative disease may lead to improved outcomes, thanks to emerging treatments.
PI-2620 is a next-generation PET imaging agent currently in Phase 3 clinical development for detecting Tau pathology in Alzheimer's disease. The compound is also being investigated in other neurodegenerative diseases by many academic researchers and in drug development trials. Tau proteins are a hallmark of several neurodegenerative disorders including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD), and accurately imaging the pathology could significantly enhance disease diagnosis and improve patient care.
Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “Fast Track designation for PI-2620 is an important reflection of its potential to accurately diagnose Alzheimer’s and other neurodegenerative diseases. Early diagnosis of these conditions will be key for effective treatment before irreversible damage occurs, and is an essential element in our goal of achieving precision prevention. The FDA has previously granted Fast Track status to two of our active immunotherapies in Phase 2 development, ACI-35.030 and ACI-24.060, which target phospho-Tau and Abeta, respectively. The designation for PI-2620 is a further recognition of AC Immune’s drug discovery and development platform and of how we, together with our partners, continue to drive innovation.”
About PI-2620
PI-2620 was discovered and developed as part of a research collaboration between AC Immune and LMI. LMI has the exclusive, worldwide license for research, development and commercialization of Tau-PET tracers generated within the discovery program. It has demonstrated robust brain uptake and fast wash-out in non-target regions, a broad imaging window between 30- and 90-minutes post-injection for AD, and excellent reproducibility between test and retest scans. The absence of significant off-target binding enables PI-2620 to detect and quantify early Tau deposition in the brain, a hallmark of neurodegenerative diseases. PI-2620 is currently under investigation in several clinical studies as a targeted radiopharmaceutical for the detection of Tau deposits in the human brain. PI-2620 also shows promise for non-AD tauopathies like progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS).
About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >
SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.
The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.
For further information, please contact:
| SVP, Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com | U.S. Investors Corey Davis, Ph.D. LifeSci Advisors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.com |
| International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: chris.maggos@cohesionbureau.com |
Forward looking statements
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FAQ
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