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Autolus Therapeutics plc (NASDAQ: AUTL) is a pioneering biopharmaceutical company dedicated to the development and commercialization of engineered T-cell immunotherapy products. These innovative therapies are designed to treat life-threatening cancers with remarkable efficacy. Autolus is at the forefront of biotechnology, focusing on both haematological and solid tumors using patient-specific T-cell therapies.
At the heart of Autolus' clinical-stage pipeline is obecabtagene autoleucel (obe-cel). Additional promising candidates include AUTO1/22, AUTO3, AUTO5, AUTO6, AUTO7, and AUTO8. These products represent the next generation of programmed T-cell therapies, offering new hope for cancer patients worldwide.
Autolus' strategic initiatives are equally impressive. The company has formed a strategic alliance with BioNTech SE, a key player in the biotech industry. This partnership is poised to enhance the development and reach of Autolus' therapies. Additionally, Autolus has successfully completed an underwritten offering, strengthening its financial foundation.
Recent financial results highlight the company's strong performance. For the full year ended December 31, 2023, Autolus reported unaudited financial results, including significant UK SME R&D Tax Credits. These credits amounted to $19.5 million and $24.6 million for the years ended December 31, 2023, and 2022, respectively, providing a substantial boost to their research and development efforts.
Looking ahead, Autolus has outlined key updates and anticipated milestones for obe-cel, along with financial results for the quarter ended March 31, 2024. These updates are critical for investors and stakeholders who are keen to track the company's progress and achievements.
In summary, Autolus Therapeutics plc is leading a transformative revolution in medicine, treating life-threatening diseases through cutting-edge T-cell therapies. The company's strategic partnerships, robust pipeline, and solid financials position it as a leader in the biopharmaceutical industry.
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.
Autolus Therapeutics (Nasdaq: AUTL) announced a significant advancement in T-cell engineering with the publication of research that enhances CAR T-cell efficacy against solid tumors by preventing apoptosis caused by Fas ligand. The study, detailed in Molecular Therapy Nucleic Acids, highlights the development of Fas-TNFR chimeras that not only inhibit FasL-mediated cell death but also stimulate CAR T-cell proliferation. Among these, the Fas-CD40 fusion was noted for its effectiveness in improving anti-tumor response in FasL presence. This research expands Autolus' toolkit against complex cancers and aligns with its strategy to enhance T-cell therapy applications, particularly for solid tumors. The findings position Autolus as a key player in advancing cancer treatment through targeted therapies.
Autolus Therapeutics (Nasdaq: AUTL) announced positive updated data for its AUTO1/22 study in pediatric B-cell Acute Lymphoblastic Leukemia (B-ALL) at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation. The study demonstrated that AUTO1/22 effectively targets both CD19 and CD22 antigens, addressing CD19 negative relapse, a common treatment failure after CAR T cell therapy.
Among the 12 patients treated, 83% achieved minimal residual disease negative complete response, including 66.7% of patients with CD19 negative disease. Importantly, there were no severe cytokine release syndrome cases, and no relapses or emergence of minimal residual disease related to antigen escape were observed after a median follow-up of 8.7 months. This demonstrates the potential of AUTO1/22 in enhancing treatment efficacy and safety for pediatric B-ALL patients.
Autolus Therapeutics plc (Nasdaq: AUTL) will host a virtual Capital Markets Day on April 27, 2023, to discuss its lead CAR T program, obe-cel, aimed at treating adults with Acute Lymphoblastic Leukemia (ALL). The event will feature presentations and a Q&A session with experts, including Dr. Lori Muffly from Stanford University and Dr. Clare Roddie from University College London, along with Matthew Gitlin from Blue Path Solutions. The session, scheduled from 10 AM to 12 PM EDT (3 PM to 5 PM BST), is open to investors and analysts. Participants can register for the webcast here. A recording will also be available on the company’s website following the event.
Autolus Therapeutics plc (Nasdaq: AUTL) has announced that it will report its Q1 2023 financial results and operational highlights on May 4, 2023, before the U.S. market opens. Management will host a conference call at 8:30 am ET to discuss these results and provide a general business update. Interested participants can pre-register for the call to receive the necessary dial-in information. An audio webcast and replay will also be available on Autolus' website for those unable to attend the live event.
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