Fortress Biotech (FBIO) Unit to Present MB-101 Data as GBM Treatment

November 21, 2016 8:34 AM EST
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Mustang Bio, Inc. (“Mustang”), a Fortress Biotech (Nasdaq: FBIO) Company, announced that Phase 1 clinical data and pre-clinical data on its MB-101 (IL13Rα2-specific Chimeric Antigen Receptor–engineered CAR T cells (CAR T cells)) product candidate in development for the treatment of glioblastoma were presented by investigators from the City of Hope (“COH”) in oral sessions at the 21st Annual Meeting and Education Day of the Society for Neuro-Oncology (“SNO”) in Scottsdale, AZ.

Dr. Lindsay A. Rosenwald, Fortress Biotech’s Chairman, President and Chief Executive Officer commented, “CAR T cell therapy has shown promise in treating certain forms of hematological cancers. However, translating that activity into solid tumors has been challenging to date. The clinical data presented at SNO by the investigators from COH suggest MB-101 is safe and well‐tolerated, and capable of eliciting a potent anti-tumor response in patients with glioblastoma (GBM), a disease that is almost universally fatal. We believe this is the first evidence of activity of CAR T cells in the treatment of GBM. We are very encouraged by the early evidence of anti-tumor activity with MB-101 with five of seven post-surgical resection patients showing stable disease for >8 weeks and, in particular, one patient showing complete response for 7.5 months. Interestingly, this patient was the only patient of the seven to receive, on a compassionate use basis, the dual delivery of CAR T cells by both intracavitary and via intraventricular administration, which provides systemic CNS delivery of the CAR T cells. We look forward to continuing to advance MB-101 in Phase 1 studies and further exploring the dual delivery approach beyond this single patient experience.”

The following summarizes the oral presentations on November 18, 2016 at SNO:

Phase I Study of Chimeric Antigen Receptor–Engineered T cells Targeting IL13Rα2 for the Treatment of GlioblastomaPresenter: Christine E. Brown, PhD, Heritage Provider Network Professor of Immunotherapy, Associate Director, T Cell Therapeutics Research Laboratory, City of Hope National Medical Center/Beckman Research Institute

The Phase I study presented showed early clinical data evaluating IL13Rα2-targeted CAR T cell therapy for the treatment of glioblastoma. On this study, patients are treated on a four-week therapeutic regimen consisting of three weekly intracranial infusions of IL13Rα2-specific CAR T cells followed by one rest week for toxicity and disease assessment. To date, seven patients have been treated with local intracavitary delivery of the CAR T cells following surgical resection.

Some highlights from the presentation included:

  • The treatment was well-tolerated in all patients treated – with No DLTs or therapy-related SAEs
  • No grade 3 or higher toxicities attributed to the therapy were observed
  • No CRS or Neurotoxicity was observed
  • Only grade ≤2 fevers, headaches, myalgia, chills
  • Best Response: 2 PD, 4 SD for >8-weeks, 1 SD→ CR following intraventricular CAR T therapy for 7.5 months

Development of murine IL13Rα2-targeted CAR T cells (mIL13BBζ) for assessment of CAR T cell therapy in syngeneic glioma modelsPresenter: Darya Alizadeh, PhD, City of Hope National Medical Center/Beckman Research Institute

The pre-clinical research program presented discussed a murine IL13Rα2-targeted CAR T cell platform that was developed to evaluate parameters that impact the efficacy of CAR T cell therapy. Overall, the development of mIL13BBζ CAR T cells and its applications will allow researchers to assess factors that may impact the efficacy of CAR T cells and provide invaluable information critical for combination therapies and clinical trial design. These studies may also provide important insights for improving therapeutic outcomes for patients with glioblastoma.

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