"Serial killer" CD19 CAR-T enters the UK Food and Drug Administration's innovative license and access path, Yimai Meng broke the news

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Click on the picture and register now June 17, 2021 /Healthcare News eMedClub News/--Recently, Autolus Therapeutics plc announced that AUTO1 (obe-cel) has obtained the British Medicines and Healthcare Products Regulatory Agency (MHRA) Innovation License and Access (ILAP), and the CAR-T cell therapy is recurring /Refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) in adult patients with Phase 1b/2 clinical study FELIX
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ILAP was announced in December 2020 and launched in early 2021.
It aims to accelerate the development and acquisition of promising drugs, mainly for drugs in the early stages of development
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This pathway is part of the UK’s plan to attract life sciences development after Brexit.
It is characterized by increased input and interaction with MHRA and other stakeholders, including the National Institute of Health and Care Excellence (NICE) and the Scottish Drug Alliance ( SMC)
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 Innovative passport recognition is the first step in the ILAP process and triggers MHRA and its partner agencies to develop a roadmap for regulatory and development milestones, with the goal of achieving early patient access in the UK
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Other benefits of ILAP include access to a range of development tools, such as the 150-day accelerated marketing authorization application (MAA) evaluation, rolling review, and the opportunity to assess the risk of ongoing returns
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"The ILAP designation of obe-cel, and the recent European Medicines Agency's (EMA) Priority Medicine (PRIME) related designation, is another step in accelerating the review process for this promising therapy," said Dr.
Christian Itin, CEO of Autolus "Obe-cel continues to show its potential different from other CAR-T cell products in terms of efficacy, durability and safety, and can change the standard of care by providing potential curative treatments for r/r ALL
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" ▲Autolus CEO Dr.
Christian Itin (photo source: biozentrum.
unibas.
ch) AUTO1 is a T cell therapy that targets CD19.
It is designed to have fast binding kinetics to CD19, allowing CAR-T cells to effectively identify cancer cells, and The injection of cytotoxic protein initiates the process of cell self-destruction, rapid dissociation, and then binds to the next cancer cell
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This process is also called "serial killer"
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Compared with traditional anti-CD19 CAR-T cell therapy, AUTO1 has the same binding rate and faster dissociation rate
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This enables it to provide higher safety while maintaining a similar level of efficacy
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 The high CR rate and excellent durability and safety of AUTO1 in children with acute B-cell leukemia have been affirmed by clinical trials
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It is currently being evaluated in two Phase 1 studies, one for relapsed/refractory adult acute lymphoblastic leukemia and the other for adult relapsed/refractory indolent B-cell lymphoma
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The company is now also advancing the program to a potential pivotal study AUTO1-AL1
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 The AUTO1-AL1 study will recruit patients with relapsed/refractory ALL
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Prior to the Phase 2 study, the study will have a brief Phase 1b
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The primary endpoint is the overall response rate, and key secondary endpoints include response duration, MRD negative CR rate, and safety
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The study will enroll approximately 100 patients in 30 leading academic and non-academic centers in the United States, the United Kingdom, and Europe
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 On June 11, Autolus updated the response duration of r/r adult acute lymphoblastic leukemia (ALL) patients at the 2021 European Hematology Association (EHA) virtual conference
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The early data provided at the conference indicated that obe-cel, as an independent therapy, also has the potential to cure some adult ALL patients
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 For more details, click on the QR code to read the reference materials in full: 1.
https://autolus.
gcs-web.
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