Recently, according to Biospace, Astellas Gene Therapies, a subsidiary of Astellas, will close a gene therapy plant in San Francisco and transfer its gene therapy production to another facility in North Carolina.As a result, at least 17 people will be laid off, affecting dozens. According to an email from an Astellas spokesperson, this move will impact 100 employees.Reasons for Factory ClosureAstellas Gene Therapies' spokesperson stated that the facility is in the process of closing and is expected to be completed by March 2025."In a statement, Astellas said it has been prioritizing resources and making operational simplifications."After evaluating its adenovirus needs, the company decided to close the facility., and transfer all plans and projects to another facility of Astellas Gene Therapies located in North Carolina.Despite the closure and planned relocation of the San Francisco-based facility, Astellas Gene Therapies' operations in California remain ongoing.In May this year, Astellas announced the opening of its West Coast Innovation Center in San Francisco, which spans approximately 150,000 square feet and serves as the hub for Astellas' gene therapy research and development operations, including Astellas Gene Therapies.
Why is there a decrease in demand for adenovirus?After evaluating its demand for adenovirus, Astellas decided to close a large biomanufacturing facility, indicating a decline in Astellas' demand for adenovirus.After understanding Astellas' failure history in AAV gene therapy, it becomes clear that Astellas indeed has reduced demand for adenoviruses.Astellas began exploring gene therapy as early as 2014 through a collaboration with Harvard University, but its formal focus on AAV gene therapy was marked by the $3 billion acquisition of Audentes Therapeutics in 2019.Then, Astellas' nightmare began.First, the AAV gene therapy AT132 for X-linked myotubular myopathy (XLMTM) faced consecutive clinical death incidents (with a total of four patient deaths reported in May 2020, June 2020, August 2020, and September 2021), leading to two clinical holds by the FDA. As of now, there is no news regarding the lifting of the clinical hold for AT132.In April 2022, Astellas terminated three preclinical AAV pipelines for Duchenne muscular dystrophy (DMD) from Audentes: AT702, AT751, and AT753.In June 2022, the FDA put another AAV gene therapy, AT845, from Astellas on clinical hold after a patient with late-onset Pompe disease treated with AT845 reported peripheral sensory neuropathy as an adverse event. The clinical hold was lifted in January 2023.
Following the consecutive failures of AAV gene therapy and the removal of multiple pipelines, Astellas has conducted an asset impairment assessment for the $3 billion acquisition of Audentes.Currently, on Astellas' official website pipeline diagram, there are only three AAV clinical pipelines from Audentes: the identity-unknown AT132 (Phase 2), the previously-problematic AT845 (Phase 1/2), and a newly mentioned one.Friedreich's Ataxia-Related Cardiomyopathy Program ASP2016 (Phase 1 Clinical Trial). Other gene therapy programs have not yet advanced to clinical trials.
Astellas' Gene Therapy Project (Image Source: Reference 2)
If AT132 is excluded, there are only two AAV products that need to produce clinical formulations. Since both are in the early stages of clinical trials and the yield requirements are not high, the demand for adenovirus vectors has decreased.
In addition to AAV gene therapy, cell therapy is also a promising direction for Astellas. To strengthen its position in the cell therapy field, Astellas acquired Universal Cells in 2018. However, the termination of its collaboration with Adaptimmune in 2023 seems to reveal potential issues with Universal Cells' stem cell technology platform.
It feels like Astellas is also on shaky ground in cell therapy......
Further Reading:Termination of TCR-T Collaboration: Astellas' Challenging CGT Journey
（This article only represents the author's viewpoint and does not reflect the platform's position.）
References:
1.https://www.biospace.com/job-trends/astellas-gene-therapies-to-close-biomanufacturing-facility-affecting-about-100-employees
2.https://www.astellas.com/en/innovation/pipeline
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