MB-109 / Fortress - LARVOL DELTA

Mustang Bio Reports Full-Year 2023 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "MB-109 (IL13Rα2-targeted CAR T-cells + HSV-1 oncolytic virus for recurrent glioblastoma):...Mustang is evaluating plans to initiate the clinical trial and request orphan drug designation for GBM, subject to resource allocation, in 2024."

FDA event • New P1 trial • Glioblastoma

Fortress Biotech Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights (Fortress Biotech Press Release) - "We are also anticipating the PDUFA goal date of January 3, 2024, for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ('cSCC'); We also expect to continue to advance our early-to-mid-clinical-stage candidates, some of which may begin pivotal trials during the next twelve to eighteen months, including: MB-106 – CD20-targeted CAR-T cell therapy for hematologic malignancies; MB-109 – IL13Rα2-targeted CAR-T cell therapy combined with HSV-1 oncolytic virus for recurrent glioblastoma and high-grade astrocytomas"

New trial • PDUFA date • Anaplastic Astrocytoma • Glioblastoma • Hematological Malignancies • Squamous Cell Skin Cancer

Mustang Bio Announces FDA Acceptance of IND Application for MB-109, a Novel Combination of MB-101 (IL13Rα2‐targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus), for the Treatment of Recurrent Glioblastoma and High-Grade Astrocytoma (GlobeNewswire) - "Mustang Bio, Inc...today announced that the U.S. Food and Drug Administration ('FDA') has accepted the Company’s Investigational New Drug ('IND') application of MB-109 for the treatment of recurrent glioblastoma ('GBM') and high-grade astrocytoma. Mustang is planning to initiate a Phase 1 multicenter clinical trial at City of Hope ('COH') and the University of Alabama at Birmingham ('UAB') to assess the safety, tolerability and efficacy of MB-109, a novel combination of MB-101 (COH-developed IL13Rα2-targeted CAR-T cell therapy) and MB-108 [Nationwide Children’s Hospital- ('Nationwide') developed HSV-1 oncolytic virus] in adult patients with recurrent GBM and high-grade astrocytomas that express IL13Rα2 on the surface of the tumor cells."

IND • New P1 trial • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Mustang Bio Announces Strategic Manufacturing Partnership and Portfolio Updates (GlobeNewswire) - "Mustang Bio, Inc...today announced a strategic update, including anticipated milestones for 2023. Mustang intends to optimize the allocation of its resources and focus on MB-106, MB-109, and in vivo CAR T platform technology. Additionally, Mustang announced a partnership with uBriGene (Boston) Biosciences Inc. ('uBriGene')...a leading cell and gene therapy contract development and manufacturing organization ('CDMO'), which includes the sale of the Company’s development, manufacturing and analytical testing facility in Worcester, Massachusetts to uBriGene....Under the terms of an asset purchase agreement between Mustang and uBriGene, uBriGene will acquire Mustang’s state-of-the-art clinical- and commercial-scale cell and gene therapy manufacturing facility in Worcester, Massachusetts, for a total consideration of $11 million."

Licensing / partnership • Anaplastic Astrocytoma • Brain Cancer • Chronic Lymphocytic Leukemia • CNS Tumor • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Glioblastoma • Glioma • Hairy Cell Leukemia • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Solid Tumor • Waldenstrom Macroglobulinemia

Mustang Bio Provides CAR T Cell Therapy Portfolio Updates and 2023 Anticipated Milestones (GlobeNewswire) - "CAR T Candidate Portfolio Highlights: MB-106...In 2023, the Company anticipates dose escalation and reporting response data at a major medical meeting....Given this, Mustang plans to treat patients with WM in the Phase 1 portion of its multicenter clinical trial to support a fast-to-market Phase 2 strategy for this indication. Data from the Fred Hutch clinical trial also support the potential of MB-106 to be administered as outpatient therapy and provide a best-in-class immunotherapy option for patients treated previously with CD19-directed CAR T cell therapy. In 2023, Mustang anticipates the U.S. Food and Drug Administration granting Orphan Drug Designation in at least one additional CD20 positive malignancy....Phase 1 clinical trials of MB-101 at City of Hope and of MB-108 at the University of Alabama at Birmingham continue to enroll patients. Additionally, Mustang will advance the preclinical investigation of MB-109 and plans to file an IND for this treatment in 2023."

Enrollment status • IND • Orphan drug • P1 data • P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

Fortress Biotech Reports Second Quarter 2022 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "Mustang expects to file an IND in 2023 to initiate an MB-109 Phase 1 clinical trial."

IND • Oncology

Mustang Bio Reports First Quarter 2022 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "...'we have additional upcoming data presentations for MB-106 at the European Hematology Association 2022 ('EHA2022') Hybrid Congress....In the second half of 2022, we plan to file an IND to initiate a Phase 1 clinical trial for MB-109 for the treatment of rGBM...'."

Clinical data • IND • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Hematological Malignancies • Oncology • Solid Tumor

Mustang Bio Announces a Phase 1 Clinical Trial Combining MB-101 (IL13Rα2‐targeted CAR T cell therapy) and MB-108 (C134 oncolytic virus) for the Treatment of Glioblastoma (GlobeNewswire) - "Mustang Bio...announced its plan to initiate a Phase I clinical trial combining CAR T cells and oncolytic virus for the treatment of recurrent glioblastoma (rGBM), supported by interim data from two ongoing investigator-sponsored Phase 1 clinical trials evaluating two clinical candidates, MB-108 (C134 oncolytic virus) and MB-101 (City of Hope’s IL13Rα2-targeted CAR T cell therapy). Preclinical data also presented support the safety of administering these two therapies sequentially in a regimen designated as MB-109. The data are from a late-breaking poster at the American Association for Cancer Research ('AACR') Annual Meeting 2022."

Late-breaking abstract • New P1 trial • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

City of Hope to Present Late-Breaking and Clinical Trial Data at AACR: Cell Therapy and Preventive Medicine (Businesswire) - "Researchers at City of Hope...will present late-breaking and clinical trial findings at this year’s American Association for Cancer Research Annual Meeting....Jianhua Yu, Michael Caligiuri and colleagues have developed a new cell therapy approach using natural killer cells that, in lab models, induced a greater response against acute myeloid leukemia (AML) and lengthened the survival of mice with AML without damaging healthy blood stem cells....When tested in mice transplanted with human non-small cell lung cancer, the innovative cell therapy City of Hope developed worked better than un-engineered natural killer cells and did not appear to affect body weight, liver or kidney function, or blood counts....The research team treated mice with brain tumors first with the oncolytic virus, then with cell therapy, and showed that together the two treatments did not cause any side effects."

Late-breaking abstract • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Mustang Bio Reports Full-Year 2021 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "...'We also plan to advance additional Mustang clinical candidates, including filing an IND for MB-109 (MB-101 autologous IL13Rα2-directed CAR T cells + MB-108 oncolytic virus) for the treatment of glioblastoma'."

IND • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Mustang Bio Announces City of Hope, University of Alabama at Birmingham and Nationwide Children’s Hospital Abstract Accepted for Late-Breaker Poster Presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022 (GlobeNewswire) - "Mustang Bio...announced that an abstract reporting on Phase 1 trials being conducted at the University of Alabama at Birmingham (UAB) and City of Hope of Mustang Bio’s exclusively licensed oncolytic viral and CAR T-cell therapies for the treatment of patients with glioblastoma (GBM), has been selected as a late-breaking poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022...'We look forward to the upcoming data to be presented...at the AACR Annual Meeting about the potential of our MB-108 oncolytic virus to enhance the efficacy of our MB-101 CAR T cell therapy for GBM....Mustang will refer to the combination therapy as MB-109, and we anticipate filing an Investigational New Drug application for MB-109 later this year'."

IND • Late-breaking abstract • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor