MB-102 / Fortress - LARVOL DELTA

Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product. (clinicaltrials.gov) - P=N/A | N=3 | Terminated | Sponsor: Mustang Bio | N=331 ➔ 3 | Trial completion date: Jul 2041 ➔ Apr 2024 | Enrolling by invitation ➔ Terminated | Trial primary completion date: Apr 2041 ➔ Apr 2024; Business Reasons

CAR T-Cell Therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia

Bispecific CD33/CD123 targeted chimeric antigen receptor T cells for the treatment of acute myeloid leukemia. (PubMed, Mol Ther Oncolytics) - "The CD33/CD123 bispecific CAR T cells were able to control acute myeloid leukemia (AML) in a xenograft AML mouse model similar to monospecific CD33 and CD123 CAR T cells while showing no on-target off-tumor effects. Based on our findings, human CD33/CD123 bispecific CAR T cells are a promising cell-based approach to prevent AML and support clinical investigation."

CAR T-Cell Therapy • Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD123 • CD33 • IL3RA

Mustang Bio Announces Amendment and Closing of Strategic Manufacturing Partnership Transaction with uBriGene (Boston) Biosciences (GlobeNewswire) - "Mustang Bio, Inc...today announced that, on July 28, 2023, it amended its previously announced asset purchase agreement with uBriGene (Boston) Biosciences Inc....closed the transaction under the terms of the amended asset purchase agreement...Per the terms of the amended agreement, at closing, uBriGene acquired all of Mustang’s assets primarily relating to the manufacturing and production of cell and gene therapies for upfront consideration of $6 million in cash....At closing, Mustang and uBriGene also entered into a manufacturing services agreement, under which Mustang contracted uBriGene to manufacture Mustang’s lead product candidates. This includes the manufacturing of MB-106..."

Licensing / partnership • M&A • Brain Cancer • Chronic Lymphocytic Leukemia • CNS Tumor • Glioblastoma • Glioma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN. (clinicaltrials.gov) - P1/2 | N=3 | Terminated | Sponsor: Mustang Bio | N=44 ➔ 3 | Trial completion date: Apr 2026 ➔ May 2023 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2026 ➔ May 2023; Business reasons.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology

Mustang Bio Announces Strategic Manufacturing Partnership and Portfolio Updates (GlobeNewswire) - "Mustang will discontinue development of its MB-102, its CD123-targeted CAR T cell therapy, as well as its HER2-, CS1- and PSCA-targeted CAR T cell therapy programs, comprising a portion of the Company’s portfolio of CAR T cell therapies being developed by the Company in partnership with City of Hope."

Discontinued • Acute Myelogenous Leukemia • Bladder Cancer • Brain Cancer • Breast Cancer • CNS Tumor • Gastric Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Hematological Malignancies • HER2 Breast Cancer • HER2 Positive Breast Cancer • Leukemia • Multiple Myeloma • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Urothelial Cancer

CD33 CAR T Cells Generated by Restrained TCR Stimulation and Optimized Cytokines Manifested Potent Antileukemic Activity and Less-Differentiated Memory Phenotype (ASGCT 2023) - "Our previous clinical trial of CD123 CAR T cells was promising but identified the need for a faster CAR T cell manufacturing process. Using a combination of restrained TCR stimulation (4D-2:1 bead) and IL2/IL15 cytokines, we optimized our CD33 CAR T cell production platform to yield highly proliferative CAR T cells with less-differentiated memory phenotype and potent antigen-dependent antileukemic efficacy."

CAR T-Cell Therapy • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD123 • CD33 • CD8 • IL15 • IL2 • IL7

Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN. (clinicaltrials.gov) - P1/2 | N=44 | Recruiting | Sponsor: Mustang Bio | Trial primary completion date: Mar 2023 ➔ Mar 2026

Trial primary completion date • Oncology

Remissions of Acute Myeloid Leukemia and Blastic Plasmacytoid Dendritic Cell Neoplasm Following Treatment with CD123-Specific CAR T Cells: A First-in-Human Clinical Trial (ASH 2017) - P1; "...The CD123CAR contains an anti-CD123 single-chain variable fragment, an optimized IgG4 CH2CH3 linker, a CD28 co-stimulatory domain, and a CD3 zeta signaling domain and is used to engineer T cells for patients enrolled on a single center, first-in-human phase I dose escalation clinical trial open at our Institution (NCT02159495)...We have also observed promising anti-leukemic activity in both AML and BPDCN. Importantly, no myeloablative effects have been observed, supporting further testing of this immunotherapeutic strategy in both transplant eligible and ineligible patients."

CAR T-Cell Therapy • P1 data • Acute Myelogenous Leukemia • Biosimilar • Graft versus Host Disease • Inflammation

Significantly Targeting Acute Myeloid Leukemia with the Combination of Anti-CD123 CAR Modified Expanded Natural Killer Cells and Romidepsin (TCT-ASTCT-CIBMTR 2023) - "Results Anti-CD123 CAR expressed on more than 96% of expanded NK cells after CAR mRNA electroporation (Fig.1A) and lasted for about one week. Anti-CD123 CAR NK showed significantly enhanced in vitro cytotoxicity against CD123 + KG1a and HL-60 with significantly enhanced IFN-"

IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD123 • NKG2D

Mustang Bio Provides CAR T Cell Therapy Portfolio Updates and 2023 Anticipated Milestones (GlobeNewswire) - "The Safety Review Team ('SRT') composed of Investigators and Mustang representatives recently met to assess the progress and safety data from the ongoing Mustang-sponsored, open label, multicenter Phase 1/2 clinical trial to evaluate the safety and efficacy of MB-102 in patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm ('BPDCN'), a rare form of leukemia….The MB-102 clinical trial is the first under Mustang’s IND in which a patient was dosed with cells processed in its own manufacturing facility. In 2023, Mustang expects to provide information about Dose Level 2 after that level is fully enrolled and the SRT has reviewed the data....Published proof-of-concept data from murine tumor model studies are anticipated in 2023. Additionally, Mustang plans to file an IND application for a multicenter Phase 1 clinical trial once a lead CAR construct has been identified."

IND • P1/2 data • Hematological Malignancies • Leukemia • Oncology

Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product. (clinicaltrials.gov) - P=N/A | N=331 | Enrolling by invitation | Sponsor: Mustang Bio

CAR T-Cell Therapy • New trial • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hairy Cell Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia

MB-102: Data from P1/2 trial (NCT04109482) for AML/BPDCN/MDS in Q4 2021 (Fortress Biotech) - Corporate Presentation

P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome

Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN. (clinicaltrials.gov) - P1/2; N=44; Recruiting; Sponsor: Mustang Bio; N=126 ➔ 44

Clinical • Enrollment change • Oncology

Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: City of Hope Medical Center; Trial completion date: Nov 2020 ➔ Nov 2021; Trial primary completion date: Nov 2020 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Immune Modulation • Inflammation • Leukemia • Myelodysplastic Syndrome • Oncology • T Acute Lymphoblastic Leukemia • CD123 • FLT3 • PCR

MB-102: Data from P1/2 trial (NCT04109482) for AML/BPDCN/MDS in Q4 2021 (Fortress Biotech) - Corporate Presentation

P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome

Mustang Bio Announces First Patient Dosed in Multicenter Phase 1/2 Clinical Trial of MB-102 (CD123-targeted CAR T Cell Therapy) (GlobeNewswire) - “Mustang Bio, Inc….announced that the first patient has been dosed in a Mustang-sponsored, open label, multicenter Phase 1/2 clinical trial to evaluate the safety and efficacy of MB-102 (CD123-targeted CAR T cell therapy) in patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (hrMDS).”

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Mustang Bio receives Orphan Drug Designation for MB-102 (CD123 CAR T) for the treatment of blastic plasmacytoid dendritic cell neoplasm (GlobeNewswire) - "Mustang Bio...today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to MB-102 (CD123 CAR T) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and incurable blood cancer with a median survival of less than 18 months and no standard of care...we expect to initiate a multicenter Phase 1/2 clinical trial in patients with acute myeloid leukemia (AML), BPDCN and high-risk myelodysplastic syndrome in 2019."

New P1/2 trial • Orphan drug • Hematological Malignancies • Oncology

Mustang Bio announces presentation of MB-102 (CD123 CAR) safety and efficacy data at AACR Special Conference on tumor immunology and immunotherapy (Mustang Bio) - "Mustang Bio, Inc...announced that additional safety and efficacy Phase 1 data evaluating MB-102 (CD123 CAR) in relapsed or refractory acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) have been selected for an oral presentation at the AACR Special Conference on Tumor Immunology and Immunotherapy....'we expect to submit an IND filing for MB-102 and look forward to initiating a multicenter Phase 1/2 clinical trial in 2019 in patients with AML, BPDCN and high-risk myelodysplastic syndrome.'"

IND • New P1/2 trial • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

MB-102: Data read-out from P1 study for AML and BPDCN in early 2018 (Fortress Biotech) - Corporate Presentation

P1 data • Acute Myelogenous Leukemia • Oncology

Mustang Bio announces MB-102 data selected for oral presentation at 59th American Society of Hematology Annual Meeting (GlobeNewswire) - "Mustang Bio...today announced that initial Phase 1 data on MB-102 (CD123 CAR) in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) has been selected for an oral presentation at the 59th American Society of Hematology (ASH) Annual Meeting. ASH will be held December 9-12, 2017..."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Mustang Bio establishes CAR T cell therapy manufacturing facility in Massachusetts (GlobeNewswire) - "Mustang Bio...announced today that it has entered into a lease agreement with the UMass Medicine Science Park...for a manufacturing facility to support the clinical development and commercialization of the Company’s CAR T product candidates...Mustang anticipates initially building cell-processing capabilities to support...MB-101 in glioblastoma, and MB-102 in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm."

Licensing / partnership • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN, AML, and hrMDS. (clinicaltrials.gov) - P1/2; N=126; Recruiting; Sponsor: Mustang Bio; Initiation date: Sep 2019 ➔ Feb 2020

Clinical • Trial initiation date

Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: City of Hope Medical Center; Trial completion date: Dec 2019 ➔ Nov 2020; Trial primary completion date: Dec 2019 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date • CD123 • FLT3 • PCR

Mustang Bio reports third quarter 2019 financial results and recent corporate highlights (Mustang Bio) - "'We look forward to a strong presence at the upcoming 61st American Society of Hematology (ASH) Annual Meeting, where additional data pertaining to MB-107 (lentiviral gene therapy) and information pertaining to MB-106 (CD20-targeted CAR T cell therapy) will be presented. With a strong balance sheet and the continued advancement of our gene therapy and CAR T programs, we are well positioned to execute on our goals for the rest of 2019 and into 2020.'"

Clinical

Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN, AML, and hrMDS. (clinicaltrials.gov) - P1/2; N=126; Recruiting; Sponsor: Mustang Bio

Clinical • New P1/2 trial