Autolus Therapeutics plc reports news on its commercial-stage biopharmaceutical business developing, manufacturing and delivering next-generation programmed T cell therapies. Updates center on AUCATZYL (obecabtagene autoleucel, or obe-cel), product revenue, manufacturing capacity, gross margin plans and the company’s acute lymphoblastic leukemia business.
Company announcements also cover clinical programs using obe-cel and related T cell therapy candidates in pediatric relapsed/refractory acute lymphoblastic leukemia, lupus nephritis and progressive multiple sclerosis. Other recurring items include financial results, operational efficiency actions, investor presentations, Nasdaq inducement equity grants and ADR-related public-company disclosures.
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Autolus Therapeutics has announced that the pivotal Phase 2 FELIX study for its CAR T cell therapy, obecabtagene autoleucel (obe-cel), will be presented at the 2023 ASCO Annual Meeting from June 2-6 in Chicago. The oral presentation, titled “Safety and efficacy of Obecabtagene autoleucel in relapsed/refractory adult B-Cell acute lymphoblastic leukemia”, highlights the efficacy of obe-cel in treating hard-to-treat adult B-cell Acute Lymphoblastic Leukemia. This investigational therapy aims to address the limitations of existing CD19 CAR T cell therapies. The trial is designed to enroll approximately 100 patients across top centers in the US, UK, and Europe with a primary endpoint of overall response rate. Autolus is also targeting the submission of a Biologics License Application by the end of 2023.
Autolus Therapeutics plc (Nasdaq: AUTL) has appointed Cardinal Health (NYSE: CAH) to facilitate the U.S. commercialization of its CAR T-cell therapies. This partnership includes a depot model for improved delivery efficiency, allowing the product to be positioned closer to treatment sites while awaiting final release. Cardinal Health will also assist with order-to-cash operations. Autolus is preparing to file a Biologics License Application (BLA) for its investigational therapy, obe-cel, by the end of 2023, with key data from the pivotal FELIX study to be presented at upcoming conferences in June. This effort aims to enhance patient access to innovative cancer therapies.