AviadoBio and Astellas Pharma have signed an option and licence agreement for AVB-101, a gene therapy for dementia, potentially worth up to $2.2bn.
AVB-101 is an investigational adeno-associated virus (AAV)-based therapy. It is currently in Phase 1/2 development for patients with frontotemporal dementia with progranulin mutations (FTD-GRN).
Frontotemporal dementia (FTD) is a severe early-onset dementia that usually results in death within three to 13 years. It causes rapid decline in executive function, unusual behaviours, language loss, apathy, and decreased mobility.
In November 2023, AviadoBio received clearance from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application, along with fast track designation for AVB-101.
This April, the gene therapy firm announced the first patient treatment in the Phase 1/2 ASPIRE-FTD trial of AVB-101.
AviadoBio CEO Lisa Deschamps said: “This strategic collaboration will combine our promising gene therapy candidate for FTD-GRN and delivery expertise with Astellas’ global capabilities in development and commercialisation 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.”
According to the terms of the agreement, Astellas Pharma will gain the option for a worldwide license to develop and commercialise AVB-101 for FTD-GRN and other indications.
Astellas Pharma will invest $20m in equity and pay up to $30m upfront for the licensing option.
London-based AviadoBio is also eligible to receive up to $2.18bn in licence fees, milestone payments, and royalties if Astellas Pharma exercises its option.
Astellas Pharma chief strategy officer Adam Pearson said: “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.”
AviadoBio was founded on research from King’s College London and the UK Dementia Research Institute. The company focuses on gene therapy development and delivery.
In late 2021, the company completed an $80m Series A financing round, following an initial $16.5m seed financing.