AUTO6NG / Autolus, BioNTech - 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

BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs (GlobeNewswire) - "Autolus will lead the development and commercialization for AUTO1/22 and AUTO6NG in any oncology indication with BioNTech having an option to support certain development activities and co-commercialize both candidates in certain territories. If BioNTech exercises an option, it will receive a profit share with respect to such exercised product candidate worldwide while Autolus will be eligible to receive an option exercise fee, milestone payments and co-funding of development expenses; Autolus granted BioNTech an exclusive license to develop and commercialize therapeutics incorporating certain of Autolus’ proprietary binders along with options to license binders and cell programming technology for use in BioNTech’s in vivo cell therapy development programs and investigational antibody-drug conjugates. If BioNTech exercises an option, Autolus will be eligible to receive exercise fees and milestones payments, with low-single digit royalties on net sales..."

Licensing / partnership • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Neuroblastoma • Oncology • Solid Tumor

Detection and quantification of integrated vector copy number by multiplex droplet digital PCR in dual-transduced CAR T cells. (PubMed, Mol Ther Methods Clin Dev) - "AUTO6NG is a dual-transduced GD2-targeting CAR that encodes distinct modules designed to enhance T cell activity in relapsed/refractory neuroblastoma...No differences were observed in measuring VCN between standard duplex and multiplex assays. Our results demonstrate that ddPCR is an accurate and cost-effective method for simultaneous detection of multiple targets in genomic DNA derived from engineered CAR T cells."

CAR T-Cell Therapy • Journal • CNS Tumor • Hematological Disorders • Hematological Malignancies • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

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

Autolus Therapeutics Reports Second Quarter 2021 Financial Results and Operational Progress (GlobeNewswire) - “Updates on the obe-cel Phase 1 trial, CAROUSEL, in Primary CNS Lymphoma in Q1 2022; Updates on the AUTO4 Phase 1 trial in TRBC1+ Peripheral TCL in H1 2022; Phase 1 trials are expected to be initiated in H1 2022 with AUTO6NG in solid tumors and AUTO5 in TRBC2+ Peripheral TCL; First exploratory allogeneic development candidate expected to enter the clinic in 2021.”

New P1 trial • New trial • P1 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma

Autolus Therapeutics Reports First Quarter 2021 Financial Results and Operational Progress (GlobeNewswire) - "Key Upcoming Clinical Milestones: 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 a potentially pivotal Phase 1b/2 clinical trial (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."

New trial • P1/2 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Multiple Myeloma • Neuroblastoma • Non-Hodgkin’s Lymphoma • 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

Autolus Therapeutics announces publication of new AUTO6 Phase 1 data in childhood neuroblastoma in Science Translational Medicine (GlobeNewswire) - P1, N=27; NCT02761915; "These new results highlight that AUTO6 can induce rapid regression of bulky disease in a solid tumor setting without inducing on-target off-tumor toxicity, despite dose dependent CAR T expansion. CAR T cell expansion was observed in all six patients treated at the higher cell dose cohorts in this Phase 1 study. Three of these six patients demonstrated evidence of transient CAR T cell activity, including cytokine release syndrome, and regression of soft tissue and bone marrow disease activity...Autolus plans to test AUTO6NG in a Phase 1 study in 2021."

New P1 trial • P1 data • Neuroblastoma • Oncology

CAR-T PIPELINE UPDATE: AUTOLUS THERAPEUTICS PRESENTS PRECLINICAL DATA ON AUT06NG | ROOTS ANALYSIS (Eurowire) - "Autolus Therapeutics...presented pre-clinical data on AUTO6NG....The results demonstrated the utility of three modules added to the clinically active and validated AUTO6 GD-2 targeting CAR that not only improves CAR T persistence but also combats the immunosuppressive environment."

Preclinical • Oncology

[VIRTUAL] AUTO6NG overcomes immune suppressive mechanisms in the TME and demonstrate preclinical anti-tumor activity in GD2-expressing solid tumors (AACR-II 2020) - "Immune-checkpoint blockade therapies has had impressive results in the clinic and are approved in multiple cancer indications. These CAR-T cells also demonstrated enhanced tumor infiltration and anti-tumor activity in vivo in xenografts mouse models. Our findings suggest that GD2 targeted CAR-T cell therapy is a viable novel approach for the treatment of multiple solid tumors indications."

IO Biomarker • Preclinical • Lung Cancer • Melanoma • Neuroblastoma • Oncology • Small Cell Lung Cancer • Thoracic Cancer

Autolus Therapeutics presents new preclinical data during the Virtual 2020 AACR Annual Meeting (GlobeNewswire) - "Autolus Therapeutics plc...announced preclinical data related to AUTO5 in T cell lymphoma and AUTO6NG in small cell lung cancer, as well as an oral presentation related to AUTO7 in prostate cancer at the American Association for Cancer Research (AACR) Virtual Annual Meeting II on June 22 - 24, 2020....'We look forward to progressing these next generation preclinical programs into the clinic in 2021.”"

Pipeline update • Preclinical • Lung Cancer • Oncology • Small Cell Lung Cancer

Autolus Therapeutics to present new data at the Virtual 2020 AACR Annual Meeting (GlobeNewswire, Autolus Limited) - "Autolus Therapeutics plc...today announced poster presentations related to AUTO5 in T cell lymphoma and AUTO6NG in small cell lung cancer, as well as an oral presentation related to AUTO7 in prostate cancer at the American Association for Cancer Research (AACR) Virtual Annual Meeting II on Jun 22 - 24, 2020."

Preclinical • Tumor microenvironment • Genito-urinary Cancer • Hematological Disorders • Hematological Malignancies • Lung Cancer • Lymphoma • Oncology • Prostate Cancer

Autolus Therapeutics reports first quarter 2020 financial results and operational progress (GlobeNewswire) - "Key Upcoming Clinical Milestones: Dosing of first patient in the pivotal program, AUTO1-AL1 in adult ALL in Q2 2020; Additional clinical data at upcoming conferences: Annual Meeting of the American Society of Clinical Oncology (ASCO): Update on the AUTO3 ALEXANDER study in DLBCL patients; Annual Meeting of the European Hematology Association (EHA): Update on AUTO1 ALLCAR19 study in adult ALL patients; Additional preclinical data at the American Association for Cancer Research II (AACR II) meeting across multiple programs; AUTO5 in T-cell lymphomas, AUTO6NG and AUTO7 in solid tumors."

Enrollment status • P1 data • P1/2 data • Preclinical • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor