Precursor B-lymphoblastic lymphoma/leukemia recurrent

LONDON, UK I December 08, 2022 I Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces that the Phase 2 pivotal FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukemia (ALL) has met its primary endpoint, based on a pre-planned interim analysis of 50 patients with morphological disease, as verified by an independent data monitoring committee (IDMC). The primary endpoint for the FELIX Phase 2 trial is the Overall Remission Rate (ORR), defined as the proportion of patients achieving Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) as assessed by an independent response review committee (IRRC). Based on 50 patients evaluated for efficacy, the ORR for obe-cel was 70%. Obe-cel showed comparable expansion and initial persistence (median follow-up 6.4 months) to the data observed in the prior ALLCAR19 study. The safety analysis was based on 92 patients treated with obe-cel and evaluable for safety. The Company observed that 3% of patients experienced Grade 3 or higher CRS, whilst 8% experienced Grade 3 or higher ICANS, and 23% of patients experienced any grade ICANS. “Obe-cel’s high level of anti-leukemia activity combined with a well manageable tolerability profile is a significant step forward in this underserved disease setting, which is characterized by the explosive growth of the leukemia and the poor condition of many patients,” said Dr. Jae Park, Associate Attending Physician at Memorial Sloan Kettering Cancer Center. “The expansion and initial persistence of obe-cel are encouraging from a long-term outcome perspective and I look forward to the next data update and the potential of obe-cel as a treatment for ALL.” “We are really pleased with the consistency of data from the interim analysis of the FELIX study with our prior results from the ALLCAR19 study in adult patients with relapsed / refractory ALL,” said Dr. Claire Roddie, Associate Professor Haematology, Cancer Institute, University College London (UCL) . “We are delighted to be announcing that our first pivotal trial conducted has met its primary endpoint based on our interim analysis, and we believe that we are one step closer to bringing this potentially innovative treatment to an underserved ALL patient population,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “We look forward to supplementing this interim data with longer follow up data to more fully explore the clinical benefit of obe-cel, and to work towards the submission of a Biologics License Application (BLA) by the end of 2023 to the U.S. Food and Drug Administration (FDA).” “We would like to thank patients and their families, our treating physicians and the clinical development and manufacturing teams for their trust, commitment and determination to deliver this study during a challenging pandemic-impacted environment.” The trial has completed screening patients for entry into the morphological cohort as the pre-specified goal of approximately 90 patients enrolled has been reached, and Autolus plans to present the results from the FELIX trial at a medical conference in mid-2023, with longer follow up planned to be reported at the end of 2023. About Autolus Therapeutics plc Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information, please visit www.autolus.com . About obe-cel (AUTO1) Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, obe-cel may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. In collaboration with Autolus’ academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trial for B-NHL. Autolus has progressed obe-cel to the FELIX trial, a pivotal trial for r/r adult ALL. About obe-cel FELIX clinical trial Autolus’ Phase 1b/2 clinical trial of obe-cel is enrolling adult patients with r/r B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint is ORR, and the secondary endpoints include duration of response, minimal residual disease (MRD) negative CR rate and safety. The trial is designed to enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom, and Europe. [NCT04404660] SOURCE: Autolus Therapeutics

CAR T-cell therapy clinical trial pipeline constitutes 193+ key companies continuously working towards developing 450+ CAR T-cell therapies, analyzes DelveInsight LAS VEGAS, Nov. 7, 2022 /PRNewswire/ -- DelveInsight's ' CAR T-cell Therapy Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline CAR T-cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the CAR T-cell therapy competitive domain. Key Takeaways from the CAR T-cell Therapy Pipeline Report Over 193+ CAR T companies are evaluating 450+ CAR T-cell therapies in various stages of development, and their anticipated acceptance in the CAR T-cell therapy market would significantly increase market revenue. Leading CAR T companies such as Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy Co., Ltd., Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company Ltd, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, and others are evaluating novel CAR T-cell Therapy drugs candidate to improve the treatment landscape. Key CAR T pipeline therapies in various stages of development include Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others. In May 2022, Novartis announced the US Food and Drug Administration (FDA) had granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Kymriah is now FDA-approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings. In April 2022, the FDA approved axicabtagene ciloleucel (brand name Yescarta) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for treating patients with primary central nervous system lymphoma. In March 2022, JW Therapeutics announced that it had received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma. In February 2022, Fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy (CT103A) received orphan drug designation (ODD) from the FDA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM), according to a press release by IASO Biotherapeutics. In June 2021, based on ZUMA-3 study data, the US FDA accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL. In April 2021, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that they had submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel for the treatment of patients with relapsed and refractory multiple myeloma. In March 2021, the FDA approved Abecma (idecabtagene vicleucel), a cell-based CAR T - Cell Therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after at least four prior lines (different types) of therapy. Abecma is the first cell-based CAR T - Cell Therapy approved by the FDA for treating multiple myeloma. Request a sample and discover the recent advances in CAR T therapies @ CAR T-cell Therapy Competitive Landscape Report CAR T-cell Therapy Overview Chimeric antigen receptors (CARs) are recombinant antigen receptors that redirect the specificity and function of T lymphocytes and other immune cells in a single molecule. Cancer Immunotherapy is one of the most promising approaches for treating severe diseases (including cancer, autoimmune diseases, and allergic-hypersensitivity reactions) because it uses and improves the immune system's standard capacity. CAR T-cells are proteins that are fusions of a specific monoclonal antibody's single-chain fragment variable and one or more T-cell receptor intracellular signaling domains. A CAR combines antigen-binding domains—most commonly, a single-chain variable fragment (scFv) derived from antibody variable domains—with TCR chain signaling domains and costimulatory domains from receptors such as CD28, OX40, and CD137. For more information about CAR T-cell therapy drugs; visit @ CAR T-cell Therapy Process CAR T-cell Therapy Pipeline Analysis: Drug Profile JWCAR029: JW Therapeutics JW Therapeutics drug JWCAR029 is a CAR-T cell product that targets CD19 and is intended to treat advanced lymphoma and leukemia (Second-line therapy or greater). The molecule is currently in phase II of development. JWCAR029 is initially being investigated for the treatment of B-cell malignancies, with a focus on relapsed and refractory DLBCL. The National Medical Products Administration ("NMPA") accepted for review its NDA for relma-cel as a third-line treatment for DLBCL in June 2020. KTE-X19: Gilead Sciences Gilead Sciences drug KTE-X19 is an autologous CD19 CAR T-cell therapy under investigation. The drug is manufactured using the XLP process, including T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is required in certain B-cell malignancies for which KTE-X19 is being studied. KTE-X19 is currently in Phase II clinical trials for the treatment of both adult and pediatric acute lymphocytic leukemia. Brexucabtagene autoleucel (formerly KTE-X19; Tecartus) has been approved by the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). A snapshot of the CAR T-cell Therapy Pipeline Drugs mentioned in the report: Learn more about FDA approved CAR T-cell therapy @ CAR T Clinical Trials Scope of the CAR T-cell Therapy Competitive Landscape Report Coverage: Global Key CAR T-cell Therapy Companies: Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy Co., Ltd., Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company Ltd, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, and others Key CAR T-cell Therapies in Pipeline: Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others. Dive deep into rich insights for CAR T-cell therapy drugs; visit @ FDA-approved CAR T-cell Therapy Table of Contents For further information on the CAR T-cell therapy pipeline therapeutics, reach out @ CAR T-cell Therapy Clinical Trials Related Reports CAR T-cell Therapy for Acute Lymphoblastic Leukemia Market CAR T-cell Therapy for Acute Lymphoblastic Leukemia Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for acute lymphoblastic leukemia companies, including Autolus, Pepromene Bio, Actinium Pharmaceuticals, among others. 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