Manufacturing Delays Set Back Autolus’ CAR-T Programs by Five Months

car t therapy

The UK biotech Autolus’ shares have slumped as construction delays from a new manufacturing site have pushed back its CAR-T cell immunotherapy programs.

Autolus is developing treatments for blood cancer that involve engineering patients’ own immune cells to kill cancer cells, known as autologous CAR-T cell immunotherapies

Earlier this year, Autolus licensed a new manufacturing facility at the UK Cell and Gene Therapy Catapult center, with the aim of producing CAR-T cell immunotherapies for clinical trials. According to Autolus’ latest report, construction and regulatory quality checks at the new facility have taken five months longer than Autolus anticipated, delaying clinical trials in several development programs. 

One program hit by the delays is AUTO3, a CAR-T cell therapy designed to kill B cells when they become cancerous in diffuse large B-cell lymphoma. Other delayed programs include AUTO4 and AUTO5. These therapies are designed to treat T cell lymphoma by killing cancerous T cells while sparing healthy T cells that are essential for fighting infections. As a result of the setback, Autolus now expects to complete a phase I trial for AUTO4 and to launch phase I trials for AUTO3 and AUTO5 mid to late next year. 

autolus car-t blood cancer immunotherapy

Investors have reacted strongly to the news, with Autolus’ stock price dropping by more than 20% on the Nasdaq Stock Exchange since last Thursday.

Manufacturing remains one of the main bottlenecks for companies developing autologous cell therapies. These treatments are expensive and difficult to scale up because they are personalized to each patient and have many steps, including genetically modifying and transporting the cells. CAR-T companies often have to build their own facilities because there are few companies able to fully manufacture these therapies externally. As Autolus’ experience shows, this process can be tricky to pull off without the occasional setback.

On top of the manufacturing issues, Autolus also announced that it will shelve another program, AUTO2, which was in phase I for the treatment of multiple myeloma. After analyzing the treatment’s clinical performance, Autolus decided that the therapy couldn’t compete with other companies developing similar therapies, such as Novartis and Johnson & Johnson. A next-generation version of AUTO2, designed to work for longer than the current generation, will begin phase I trials next year.

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