Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 17

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 17
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 cell exhaustion and maintain a TCM
or TN/MEM phenotype. Based on experiments with CAR-Ts in mouse xenograft models of GBM,
these CAR-modified TCM and TN/MEM cells
have been shown to be more potent and persistent than earlier generations of CAR-T cells.

Our academic partners at COH have recently completed
the treatment phase of their Phase 1 study, which was designed to assess the feasibility and safety of using TCM
or TN/MEM enriched IL13Rα2-specific CAR-engineered T cells for clinical study participants
with IL13Rα2 recurrent/refractory malignant glioma (ClinicalTrials.gov Identifier: NCT02208362). In this study, COH enrolled and
treated 65 patients, with 58 patients receiving 3 cycles of CAR T cells per the study protocol. In March 2024, results from this study
were published in Nature Medicine. Preliminary data indicated that the CAR-T cells were well tolerated, and no dose-limiting toxicities
were observed in any of the study arms nor where there any occurrences of CRS or treatment-related deaths. Of the 58 patients evaluable
for disease response, 50% achieved stable disease (SD) or better; 22%, including 8 patients with grade 4 gliomas, achieved SD or better
for at least 90 days. Two patients achieved partial response, and one patient achieved complete response on the study. In 2016 COH reported
that a patient had achieved a complete response to treatment based on the imaging and clinical features set forth by the Response Assessment
in Neuro-Oncology Criteria (“RANO”). This result was published as a case report in the New England Journal of Medicine
(Brown CE et al. NEJM. 2016;375:2561-9). As described in the paper, this patient diagnosed with recurrent multifocal glioblastoma
received multiple infusions of IL13Rα2-specific CAR-T cells over 220 days through two intracranial delivery routes – infusions
into the resected tumor cavity followed by infusions into the ventricular system. Intracranial infusions of IL13Rα2-targeted CAR-T
cells were not associated with any toxic effects of grade 3 or higher. After CAR-T cell treatment, regression of all intracranial and
spinal tumors was observed, along with corresponding increases in levels of cytokines and immune cells in the cerebrospinal fluid