BioNTech passes on Autolus CD19/22 CAR-T option

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Amid its 2024 financial results, Autolus Therapeutics revealed that BioNTech chose not to exercise its product option for Autolus’ dual targeting CD19/22 CAR-T cell therapy, AUTO1/22.

According to Autolus, BioNTech chose not to exercise its co-commercialization rights due to “pipeline prioritization,” allowing the option to expire as of February 8, 2025. The decision means that Autolus will lose out on an option exercise fee, milestone payments and co-funding of development expenses.

In February 2024, the two signed a $250 million broad CAR-T manufacturing deal. As part of a larger deal, BioNTech secured an option on AUTO6NG, a T-cell therapy targeting GD2, as well as the opportunity to co-commercialize AUTO1/22. The therapy is currently being studied in a phase 1 trial of children with high risk, relapsed CD19+ and/ or CD22+ hematological malignancies.

BioNTech didn’t mention AUTO1/22 or the company’s decision when it reported its 2024 financials last week. The COVID vaccine maker, which anticipates lower earnings for 2025, is restructuring its pipeline and workforce to focus on mRNA-based oncology therapies.

In good news for Autolus, the company also reported that its U.S. launch for its first commercial product, Aucatzyl, is progressing on track with 33 authorized treatment centers. The FDA approved Aucatzyl, a CD19-directed genetically modified autologous T-cell immunotherapy for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia back in November.

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