Astellas and AviadoBio Announce Exclusive Option and License Agreement for Gene Therapy AVB-101 Targeting Frontotemporal Dementia and Other Indications
AviadoBio and Astellas Pharma have announced an exclusive option and license agreement for AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development for patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Under the agreement, Astellas will have the option to receive worldwide exclusive license for development and commercialization rights to AVB-101 in FTD-GRN and other potential indications.
Astellas will make a $20 million equity investment and up to $30 million in upfront payments for the option to license AVB-101. AviadoBio is eligible to receive up to $2.18 billion in license fees and milestone payments plus royalties if Astellas exercises its option. The collaboration aims to address the unmet need in frontotemporal dementia, combining AviadoBio's gene therapy candidate and delivery expertise with Astellas' global capabilities in development and commercialization of gene therapies.
AviadoBio e Astellas Pharma hanno annunciato un accordo esclusivo di opzione e licenza per AVB-101, una terapia genica basata su AAV in fase di sviluppo 1/2 per pazienti affetti da demenza frontotemporale con mutazioni nel progranulina (FTD-GRN). Sotto l'accordo, Astellas avrà l'opzione di ricevere una licenza esclusiva a livello mondiale per i diritti di sviluppo e commercializzazione di AVB-101 in FTD-GRN e altre potenziali indicazioni.
Astellas effettuerà un investimento azionario di 20 milioni di dollari e fino a 30 milioni di dollari in pagamenti anticipati per l'opzione di licenza di AVB-101. AviadoBio è idonea a ricevere fino a 2,18 miliardi di dollari in diritti di licenza e pagamenti per traguardi, oltre a royalty se Astellas esercita la sua opzione. La collaborazione mira a soddisfare l'esigenza non soddisfatta nella demenza frontotemporale, combinando il candidato terapia genica di AviadoBio e l'esperienza nella consegna con le capacità globali di Astellas nello sviluppo e nella commercializzazione di terapie geniche.
AviadoBio y Astellas Pharma han anunciado un acuerdo exclusivo de opción y licencia para AVB-101, una terapia génica investigacional basada en AAV en desarrollo de fase 1/2 para pacientes con demenicia frontotemporal con mutaciones en progranulina (FTD-GRN). Bajo el acuerdo, Astellas tendrá la opción de recibir una licencia exclusiva mundial para los derechos de desarrollo y comercialización de AVB-101 en FTD-GRN y otras posibles indicaciones.
Astellas realizará una inversión de capital de 20 millones de dólares y hasta 30 millones de dólares en pagos iniciales para la opción de licenciar AVB-101. AviadoBio es elegible para recibir hasta 2,18 mil millones de dólares en regalías de licencias y pagos por hitos, además de regalías si Astellas ejerce su opción. La colaboración tiene como objetivo abordar la necesidad no satisfecha en la demencia frontotemporal, combinando el candidato de terapia génica de AviadoBio y su experiencia en entrega con las capacidades globales de Astellas en el desarrollo y comercialización de terapias génicas.
AviadoBio와 Astellas Pharma는 AVB-101에 대한 독점 옵션 및 라이센스 계약을 발표했습니다. 이는 프론토템포럴 치매 프로그라눌린 변이(FTD-GRN) 환자를 위한 AAV 기반의 임상 개발 중인 유전자 치료제이며, 현재 1/2 단계에 있습니다. 계약에 따라 Astellas는 FTD-GRN 및 기타 잠재적 적응증에 대한 AVB-101의 개발 및 상용화 권리에 대한 전 세계 독점 라이센스를 받을 옵션을 가지게 됩니다.
Astellas는 AVB-101의 라이센스 옵션을 위한 2천만 달러의 자본 투자와 3천만 달러의 선불 지급을 할 것입니다. Astellas가 옵션을 행사할 경우, AviadoBio는 21억 8천만 달러의 라이센스 수수료 및 이정표 지급과 로열티를 포함하여 최대 수익을 받을 수 있는 자격이 있습니다. 이 협력은 프론토템포럴 치매에서 충족되지 않은 수요에 대응하는 것을 목표로 하며, AviadoBio의 유전자 치료 후보와 전달 전문성을 Astellas의 유전자 치료 개발 및 상용화의 글로벌 역량과 결합하고자 합니다.
AviadoBio et Astellas Pharma ont annoncé un accord exclusif d'option et de licence pour AVB-101, une thérapie génique expérimentale basée sur AAV en développement de phase 1/2 pour les patients atteints de démence frontotemporale avec mutations du progranuline (FTD-GRN). En vertu de cet accord, Astellas aura l'option de recevoir une licence exclusive mondiale pour les droits de développement et de commercialisation d'AVB-101 dans la FTD-GRN et d'autres indications potentielles.
Astellas effectuera un investissement en capital de 20 millions de dollars et jusqu'à 30 millions de dollars en paiements anticipés pour l'option de licence d'AVB-101. AviadoBio est éligible à recevoir jusqu'à 2,18 milliards de dollars en frais de licence et paiements de jalons, ainsi que des redevances si Astellas exerce son option. La collaboration vise à répondre aux besoins non satisfaits en matière de démence frontotemporale, en combinant le candidat de thérapie génique et l'expertise de livraison d'AviadoBio avec les capacités mondiales d'Astellas dans le développement et la commercialisation de thérapies géniques.
AviadoBio und Astellas Pharma haben eine exklusive Option und Lizenzvereinbarung für AVB-101 angekündigt, eine experimentelle, AAV-basierte Gentherapie in der Phase 1/2 für Patienten mit frontotemporaler Demenz mit Progranulin-Mutationen (FTD-GRN). Im Rahmen der Vereinbarung erhält Astellas die Möglichkeit, eine weltweite exklusive Lizenz für die Entwicklungs- und Vermarktungsrechte an AVB-101 für FTD-GRN und andere potenzielle Indikationen zu erhalten.
Astellas wird eine Investition in Höhe von 20 Millionen Dollar und bis zu 30 Millionen Dollar im Voraus für die Option zur Lizenzierung von AVB-101 leisten. AviadoBio ist berechtigt, bis zu 2,18 Milliarden Dollar an Lizenzgebühren und Meilensteinzahlungen sowie Tantiemen zu erhalten, falls Astellas seine Option ausübt. Die Zusammenarbeit zielt darauf ab, den ungedeckten Bedarf an frontotemporaler Demenz zu adressieren, indem die Gentherapiewahl von AviadoBio und deren Lieferungsexpertise mit den globalen Fähigkeiten von Astellas in der Entwicklung und Vermarktung von Gentherapien kombiniert wird.
- Astellas makes a $20 million equity investment in AviadoBio
- AviadoBio to receive up to $30 million in upfront payments
- Potential for AviadoBio to receive up to $2.18 billion in license fees and milestone payments plus royalties
- Collaboration expands Astellas' gene therapy pipeline in neurodegenerative diseases
- AVB-101 is in Phase 1/2 development, showing progress in clinical trials
- Astellas' option to license AVB-101 is not guaranteed
- FTD-GRN is a rare disease, potentially limiting market size
- Gene therapy development carries inherent risks and uncertainties
Astellas receives an exclusive option to license AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development
AviadoBio receives
FTD is a devastating form of early-onset dementia that typically leads to death within three to 13 years from diagnosis. People with FTD commonly experience a rapid decline in executive function (attention control, working memory, problem-solving etc.), uncharacteristic behaviors, loss of language, apathy, and reduced mobility. It is an important cause of dementia in those under the age of 65 and is often underrecognized, and misdiagnosed. 1,2,3,4
Under the terms of the agreement, Astellas will have the option to receive a worldwide exclusive license for the development and commercialization rights to AVB-101 in FTD-GRN and other potential indications. Astellas will make a
Lisa Deschamps, CEO, AviadoBio
"As we complete dosing of the first cohort of patients in our Phase 1/2 ASPIRE-FTD trial of AVB-101, we are excited about the potential of this collaboration to help address the unmet need that exists today in frontotemporal dementia. This strategic collaboration will combine our promising gene therapy candidate for FTD-GRN and delivery expertise with Astellas' global capabilities in development and commercialization of gene therapies. Together, we can further accelerate delivering this investigational medicine to families around the world who so desperately need treatment options for FTD-GRN and other neurological diseases."
Adam Pearson, Chief Strategy Officer, Astellas
"We look forward to collaborating with the team at AviadoBio as we expand our gene therapy pipeline to help a broader range of people living with debilitating, neurodegenerative diseases. AVB-101 represents a truly innovative approach to the treatment of FTD-GRN and has the potential to be part of the next generation of gene therapy products through the creation of this agreement. Genetic regulation remains a cornerstone of our primary focus strategy at Astellas and this agreement helps us to continue to provide potential solutions for patients in need."
About AviadoBio
At AviadoBio, we are relentlessly chasing cures by translating groundbreaking science and precision delivery into life-changing medicines for people living with neurological conditions. With our deep understanding of the brain and suite of proprietary gene therapy platforms and delivery technologies, AviadoBio is working to overcome the challenges of delivering the right drug to the right place. Its innovative, neuroanatomy-led approach is designed to maximize the therapeutic potential of gene therapy to halt or potentially reverse neurodegenerative diseases. AviadoBio was founded on pioneering research from King's College London and the
AviadoBio's investors include New Enterprise Associates (NEA), Monograph Capital, F-Prime Capital, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), SV Health Investor's Dementia Discovery Fund (DDF), Advent Life Sciences, EQT Life Sciences (Dementia Fund), and LifeArc Ventures.
For more information, please visit www.aviadobio.com and follow us on X @AviadoBio and LinkedIn at AviadoBio.
About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines with the potential to deliver transformative value for patients. Our gene therapy drug discovery engine is built around innovative science, a validated AAV platform, and industry leading internal manufacturing capability with a particular focus on rare diseases of the eye, CNS and neuromuscular system. Astellas Gene Therapies will also be advancing additional Astellas gene therapy programs toward clinical investigation. Astellas Gene Therapies is based in
Astellas Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
- Onyike CU and Diehl-Schmid J. Int Rev Psychiatry. 2013;25(2):130–137;
- Riedl L et al. Neuropsychiatr Dis Treat. 2014;10:297–310;
- Onyike CU. Neuroepidemiology. 2011;37:166–167;
- Kansal K et al. Dement Geriatr Cogn Disord. 2016;41:109–122;
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SOURCE Astellas Pharma Inc.
FAQ
What is the purpose of the agreement between AviadoBio and Astellas Pharma (ALPMY)?
How much is Astellas investing in AviadoBio as part of this agreement?
What is the potential value of the deal for AviadoBio if Astellas exercises its option?
What stage of development is AVB-101 currently in?
