AUTO8 / Autolus, University College London - LARVOL DELTA

Autolus Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates (GlobeNewswire) - "Clinical programs AUTO8 and AUTO6NG are progressing, and the Company is planning updates for programs at its R&D event which will be held on April 23, 2025."

Clinical • Oncology

Autolus Therapeutics Reports Third Quarter 2024 Financial Results and Business Updates (GlobeNewswire) - "Pipeline programs in collaboration with University College London Clinical programs AUTO8, AUTO6NG and AUTO1/22 are progressing and the Company is planning data updates for all programs in 2025. Operational Updates: The FDA approval for AUCATZYL triggers a $30 million milestone payment to Autolus from Blackstone in accordance with the terms of the collaboration agreement between the parties. In addition, Autolus will make a £10 million regulatory milestone payment to UCL Business Ltd. in accordance with the license agreement between the parties."

Clinical data • Financing • B Acute Lymphoblastic Leukemia

Autolus Therapeutics Reports Second Quarter 2024 Financial Results and Business Updates (GlobeNewswire) - "Clinical programs AUTO8, AUTO6NG and AUTO1/22 are progressing well and we are planning data updates for all programs in 2025...2024 Expected News Flow: Obe-cel FELIX data at American Society of Hematology (ASH) meeting...December 2024...Research and development expenses increased from $33.2 million to $36.6 million for the three months ended June 30, 2024, compared to the same period in 2023. This change was primarily due to increases in operating costs related to our new manufacturing facility, employee salaries and related costs, and clinical trial and manufacturing costs related to obe-cel, partially offset by an increase in our U.K. reimbursable R&D tax credits that reduce R&D expense....Autolus estimates that, with its current cash and cash equivalents, it is well capitalized to drive the full launch and commercialization of obe-cel in r/r adult B-ALL..."

Clinical data • Commercial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Solid Tumor

Autolus Therapeutics Reports First Quarter 2024 Financial Results and Business Updates (GlobeNewswire) - "Further long-term data from the FELIX study including additional subset analysis will be presented in oral and poster presentations at the American Society of Clinical Oncology annual meeting (ASCO – May 31 – June 4, 2024), and European Hematology Association congress (EHA – June 13 – 16, 2024) respectively...AUTO8 is a next-generation product candidate for multiple myeloma, which includes two CARs for the multiple myeloma targets, BCMA and CD19...Enrollment of the initial cohorts are complete and further updates from the MCARTY study are anticipated in H2 2024...Obe-cel Marketing Authorization Application to MHRA Second half 2024..."

MHRA filing • P1/2 data • Trial status • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology

Autolus Therapeutics Presents Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2023 (Yahoo Finance) - P1 | N=24 | MCARTY (NCT04795882) | "As of November 13, 2023 (data cut-off), 11 patients have been infused with either BCMA CAR at 50 million (n=3) or 150 million (n=3) cells, or AUTO8 at 50 million (n=3) or 150 million (n=2). At a median follow-up of 6 months we observed 100% response rate (ORR), with 3 PR, 1 VGPR, 7 CR/sCR (all evaluable MRD negative). Two patients remained in ongoing sCR > 12 months. No cases of ICANS or CRS ≥ Gr 3 were observed across all subjects during the period. While persistence data from the dual targeting cohort is immature, it demonstrates expansion of three CAR populations and suggests a trend to increased persistence of D8 BCMA CAR expressing T cells."

P1 data • Multiple Myeloma

Autolus Therapeutics to Present Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2023 in Two Oral Presentations and Two Poster Presentations (Autolus) - "obe-cel: oral presentation – pooled analysis of the ongoing FELIX Phase Ib/II study; AUTO8: oral presentation of MCARTY Phase I Study; obe-cel: poster presentation - pooled analysis from ALLCAR19 and FELIX Phase Ib studies and ALLCAR19 extension; obe-cel: poster presentation - CMC demonstrating the robustness of obe-cel manufacturing."

Clinical • P1 data • P1/2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Multiple Myeloma • Oncology

Autolus Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates (GlobeNewswire) - "AUTO8 in Multiple Myeloma – Phase 1 MCARTY Study: AUTO8 is a next-generation product candidate for multiple myeloma, which comprises two CARs for the multiple myeloma targets, BCMA and CD19. In collaboration with UCL, the Company initiated a study in 2022. Patients continue to be enrolled and initial data will be presented at ASH in December 2023."

Enrollment status • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Autolus Therapeutics Reports Second Quarter 2023 Financial Results and Operational Progress (GlobeNewswire) - "AUTO8 in Multiple Myeloma – Phase 1 MCARTY Study : Patients continue to be enrolled and initial data is expected by the end of 2023; AUTO6NG in Neuroblastoma: In collaboration with UCL, the Company is planning on initiating a clinical trial of AUTO6NG in 2023."

New trial • P1 data • Hematological Malignancies • Multiple Myeloma • Neuroblastoma • Oncology • Solid Tumor

Autolus Therapeutics Reports Third Quarter 2022 Financial Results and Operational Progress (GlobeNewswire) - "AUTO4 in T Cell Lymphoma patients – LibrA T1 Trial: Autolus has optimized the manufacturing process for AUTO4, and is currently enrolling additional patients into the trial to test this manufacturing change. Data were presented at EHA in June 2022, and longer-term follow up data will be presented at the 2022 ASH Meeting in December....AUTO8 in Multiple Myeloma – MCARTY Trial: In collaboration with UCL, patients continue to be enrolled into the AUTO8 Phase 1 clinical trial, with first data expected in H2 2023....AUTO6NG in Neuroblastoma – MCARGD2 Trial: In collaboration with UCL, the first patient is expected to be dosed in the Phase 1 MCARGD2 clinical trial in H1 2023, with initial data expected towards the end of 2023."

P1 data • P1/2 data • Trial status • Hematological Malignancies • Lymphoma • Multiple Myeloma • Neuroblastoma • Oncology • Solid Tumor

Autolus Therapeutics Reports First Quarter 2022 Financial Results and Operational Progress (GlobeNewswire) - "Key Anticipated Clinical Milestones: Initial clinical data from the FELIX Phase 2 trial in H2 2022 and full data in H1 2023. Updated Phase 1 data from the ALLCAR19 extension trial in patients with r/r B-NHL and CLL presented as a poster at the EHA Congress in June 2022. Updates on the obe-cel Phase 1 CAROUSEL trial in Primary CNS Lymphoma presented as a poster at the EHA Congress in June 2022. Initial clinical data from the AUTO1/22 CARPALL extension trial in pediatric ALL presented as an oral presentation at the EHA Congress in June 2022, with longer follow up in H2 2022. Initial clinical data from AUTO4 LibraT1 Phase 1 trial in TRBC1+ Peripheral TCL presented as an oral presentation at the EHA Congress in June 2022. AUTO6NG Phase 1 clinical trial in neuroblastoma expected to start in H2 2022. Expect first data in H2 2023. AUTO8 Phase 1 clinical trial in patients with multiple myeloma has started, expect first data in H2 2023."

Clinical data • New P1 trial • Hematological Malignancies • Multiple Myeloma • Neuroblastoma • Oncology • Solid Tumor

Autolus Therapeutics Reports Third Quarter 2021 Financial Results and Operational Progress (GlobeNewswire) - "Key Anticipated Clinical Milestones: Non-clinical data and initial data from the AUTO1/22 CARPALL extension trial in pediatric ALL expected at ASH in December 2021; Updates on the AUTO4 Phase 1 trial in TRBC1+ Peripheral TCL expected in H1 2022; Phase 1 trials are expected to be initiated in Q4 2021 with AUTO8 in Multiple Myeloma; Phase 1 trials are expected to be initiated in H1 2022 with AUTO6NG in solid tumors and AUTO5 in TRBC2+ Peripheral TCL."

Clinical data • New P1 trial • Childhood B Acute Lymphoblastic Leukemia • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

MCARTY: A New Study Evaluating the Activity of Modular CAR T for mYeloma (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: University College, London; Trial completion date: Mar 2035 ➔ Jun 2035; Initiation date: Sep 2021 ➔ Dec 2021; Trial primary completion date: Apr 2025 ➔ Jul 2025

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Autolus Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Progress (GlobeNewswire) - “AUTO7 in prostate cancer: Autolus plans to progress AUTO7 into the clinic in H1 2022...AUTO1 updates in 2021 on ALLCAR19 in patients with r/r B-NHL and longer term follow up of the fully enrolled r/r aALL cohort; AUTO1 - Currently enrolling Phase 1b/2 pivotal study (FELIX) in r/r adult ALL patients with data expected in 2022; Updates on Phase 1 programs AUTO1/22 in pediatric ALL, as well as AUTO4 in TRBC1+ Peripheral TCL, in 2021; Phase 1 trials are expected to be initiated in 2021 with AUTO1 in Primary CNS Lymphoma, AUTO5 in TRBC2+ Peripheral TCL, AUTO6NG in Neuroblastoma, and AUTO8 in Multiple Myeloma; First exploratory allogeneic program expected to enter the clinic in H1 2021.”

New P1 trial • New trial • P1 data • P1/2 data • Acute Lymphocytic Leukemia • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Multiple Myeloma • Neuroblastoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Prostate Cancer • Small Cell Lung Cancer

MCARTY: A New Study Evaluating the Activity of Modular CAR T for mYeloma (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: University College, London

Clinical • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology