MB-101 / Fortress - LARVOL DELTA

NCI-2014-01488: Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma (clinicaltrials.gov) - P1 | N=65 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2024 ➔ Jul 2025

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Malignant Glioma • Oncology • Solid Tumor • IL13RA2

Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2024 ➔ Oct 2025

CAR T-Cell Therapy • Immune cell • Metastases • Trial completion date • Trial primary completion date • Adrenal Cortex Carcinoma • Breast Cancer • CNS Tumor • Cutaneous Melanoma • Endocrine Cancer • Eye Cancer • Genito-urinary Cancer • Glioma • Head and Neck Cancer • Hepatology • Lung Adenocarcinoma • Lung Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • Uveal Melanoma • BRAF

NCI-2014-01488: Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma (clinicaltrials.gov) - P1 | N=65 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • IL13RA2

CAR T Therapy Shows Some Significant Responses in High Grade Glioma (CGTLive) - P1 | N=82 | NCT02208362 | "MB-101 (Mustang Bio) chimeric antigen receptor (CAR) T-cell therapy was well-tolerated and yielded stable disease or better in 50% of patients with high-grade glioma (HGG), including 2 complete responses (CRs) and 2 partial responses (PRs)...The trial evaluated MB-101, IL-13Rα2-targeted CAR-T cells, in 65 patients with recurrent high-grade glioma, most of which had grade 4 glioblastoma (GBM) IDH wildtype (n = 41; 72%)...Common adverse events (AEs) included fatigue, headache, and hypertension with possibly related, serious AEs occurring in 35% (95% CI, 24–48%) of patients....In looking at survival, median overall survival (OS) was 8 months. Patients with recurrent GBM that received ICT/ICV delivery of the optimized manufacturing product had a superior median OS of 10.2 months compared with an expected 6 months."

P1 data • CNS Tumor • Glioblastoma • Glioma • Oncology

Mustang Bio Announces Publication in Nature Medicine of Data from Phase 1 Trial Evaluating MB-101 IL13Rα2-targeted CAR T-Cells in High-Grade Glioma (GlobeNewswire) - P1 | N=82 | NCT02208362 | "Stable disease or better was achieved in 50% (29/58) of heavily pretreated patients for at least two months, with two partial responses, one complete response (CR), and a second CR after additional CAR-T cycles under compassionate use....Patients with recurrent GBM treated in the final cohort with dual intratumoral (ICT)/ intraventricular (ICV) delivery and an optimized manufacturing process exhibited superior median overall survival of 10.2 months, compared to the expected survival rate of six months in patients with recurrent GBM. The median overall survival for all patients was eight months....Overall, all routes of delivery (ICT, ICV and dual ICT + ICV) were well-tolerated at doses up to 200×106 CAR T-cells."

P1 data • CNS Tumor • Glioma • Oncology • Solid Tumor

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

Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma (clinicaltrials.gov) - P1 | N=82 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Immune Modulation • Oncology • Solid Tumor • IL13RA2

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

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

Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Dec 2023 ➔ Nov 2025 | Trial primary completion date: Dec 2023 ➔ Nov 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Brain Cancer • Ependymoma • Glioblastoma • Medulloblastoma • Oncology • Solid Tumor • CD123

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

Mustang Bio Reports Third Quarter 2021 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "Mustang Bio, Inc...announced financial results and recent corporate highlights for the third quarter ended September 30, 2021....As of September 30, 2021, Mustang’s cash and cash equivalents and restricted cash totaled $121.9 million, compared to $130.9 million at June 30, 2021, and $98.8 million as of December 31, 2020, a decrease of $9.0 million for the quarter and an increase of $23.1 million year-to-date."

Clinical data • Commercial • Chronic Lymphocytic Leukemia • Glioblastoma • Glioma • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology

Mustang Bio Announces MB-101 (IL13Rα2‐targeted CAR T cells) Scientific Presentations at Upcoming Virtual Conferences (GlobeNewswire) - "Mustang Bio, Inc...today announced that Christine Brown, Ph.D., Deputy Director, T Cell Therapeutics Research Laboratory and The Heritage Provider Network Professor in Immunotherapy, will present updated Phase 1 clinical data regarding MB-101 (IL13Rα2-targeted CAR T cells) at two upcoming scientific conferences in October 2021."

P1 data • Brain Cancer • Glioblastoma • Oncology

Mustang Bio Announces MB-101 (IL13Rα2‐targeted CAR T cells) Scientific Presentations at Upcoming Virtual Conferences (Fortress Biotech Press Release) - "Mustang Bio, Inc....announced that Christine Brown, Ph.D., Deputy Director, T Cell Therapeutics Research Laboratory and The Heritage Provider Network Professor in Immunotherapy, will present updated Phase 1 clinical data regarding MB-101 (IL13Rα2-targeted CAR T cells) at two upcoming scientific conferences in October 2021."

P1 data • CNS Tumor • Glioblastoma • Glioma • Oncology

Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: City of Hope Medical Center; Trial completion date: Dec 2022 ➔ Dec 2023; Trial primary completion date: Dec 2022 ➔ Dec 2023

CAR T-Cell Therapy • Clinical • Trial completion date • Trial primary completion date • Brain Cancer • Ependymoma • Glioblastoma • Medulloblastoma • Oncology • Solid Tumor • MRI

Mustang Bio and City of Hope Announce First Patient Dosed in Phase 1 Clinical Trial of MB-101 (IL13Rα2-specific CAR T cells) to Treat Leptomeningeal Brain Tumors (GlobeNewswire) - “Mustang Bio, Inc…and City of Hope…announced that the first patient has been dosed in a clinical trial to establish the safety and feasibility of administering MB-101 (autologous IL13Rα2-CAR T cells) to patients with leptomeningeal brain tumors (e.g., glioblastoma, ependymoma or medulloblastoma). The trial will enroll up to 30 patients and is taking place at City of Hope, where this chimeric antigen receptor T (‘CAR T’) cell therapy was initially developed.”

Trial status • Brain Cancer • Glioblastoma • Oncology

Mustang Bio and City of Hope Announce Initiation of Phase 1 Clinical Trial of MB-101 (IL13Rα2-specific CAR T cells) to Treat Leptomeningeal Brain Tumors (GlobeNewswire) - "Mustang Bio, Inc...announced that a Phase 1 single-center, two-arm clinical trial has been initiated to establish the safety and feasibility of administering MB-101 (autologous IL13Rα2-CAR T cells) to patients with leptomeningeal brain tumors (e.g., glioblastoma, ependymoma or medulloblastoma). The trial will enroll up to 30 patients and take place at City of Hope, where the chimeric antigen receptor T ('CAR T') cell therapy was initially developed."

Trial status • Brain Cancer • Ependymoma • Glioblastoma • Medulloblastoma • Oncology

MB-101: Data read-out from P1 study for malignant glioma in early 2018 (Fortress Biotech) - Corporate Presentation

P1 data • Oncology

Co-inoculation of different antagonists can enhance the biocontrol activity against Rhizoctonia solani in tomato. (PubMed, Antonie Van Leeuwenhoek) - "In the present study, a microbial consortia based management strategy involving the microbes Bacillus velezensis MB101 (BV), Streptomyces atrovirens N23 (SA) and Trichoderma lixii NAIMCC-F-01760 (TL), was evaluated for the management of Rhizoctonia solani (RS), the causal agent of tomato root rot...Furthermore, three application methods were assessed in the field, and SA + TL showed maximum disease reduction (76%) by the dual application. Based on glasshouse and field study results, it was concluded that co-inoculation of SA + TL activated plant defense against RS as compared to the individual microbes, and co-inoculation could be a new effective strategy to manage the root rot pathogen in an eco-compatible manner."

Journal

City of Hope is enrolling patients in first of its kind clinical trial for brain tumor patients (Businesswire) - “The trial, which received a $4.1 million in grants from the National Institutes of Health and Gateway for Cancer Research, combines City of Hope’s unique CAR T cell therapy with immune checkpoint inhibitors...City of Hope has opened a first-in-human clinical trial for patients with recurrent glioblastoma – the trial is the first to combine City of Hope’s chimeric antigen receptor (CAR) T cells that target the IL13Rα2 antigen common on brain tumor cells in combination with nivolumab...an anti-PD1 antibody, and ipilimumab...also a checkpoint inhibitor that blocks the CTLA-4 protein.”

Financing • New trial

Mustang Bio and Nationwide Children’s Hospital Receive Orphan Drug Designation for MB-108 (Oncolytic Virus C134) for the Treatment of Malignant Glioma (GlobeNewswire, Mustang Bio, Inc.) - "Mustang Bio...and Nationwide Children’s Hospital...announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to MB-108 (oncolytic virus C134) for the treatment of malignant glioma, a type of brain cancer with a median survival of less than 18 months....Mustang intends to combine MB-108 with MB-101 (IL13Rα2-specific CAR) to potentially enhance efficacy in treating glioblastoma multiforme.”."

Clinical • IO Biomarker • Oncolytic Virus • Orphan drug • Regulatory

Mustang Bio and Nationwide Children’s Hospital Enter into Exclusive Worldwide License Agreement for Oncolytic Virus (C134) to Treat Glioblastoma Multiforme (GlobeNewswire, Mustang Bio, Inc.) - "Mustang intends to combine the oncolytic virus (C134) with MB-101 (IL13Rα2-specific CAR) to potentially enhance efficacy in treating glioblastoma multiforme. Subsequent clinical trials will investigate a combination treatment of MB-101 (IL13Rα2-specific CAR) and C134."

Licensing / partnership • New trial • Oncolytic Virus