8-K – Current report

On April 18, 2016 Mustang Bio, Inc. ("Mustang"), a Fortress Biotech (NASDAQ: FBIO) Company, reported that two abstracts pertaining to its MB-101 (IL13Rα2-specific CAR-T cells) product candidate in development were selected for presentation at the upcoming American Society of Gene and Cell Therapy 19th Annual Meeting (ASGCT) (Free ASGCT Whitepaper), to be held May 4-7, 2016, at the Marriott Wardman Park Hotel in Washington, DC (Filing, 8-K, Fortress Biotech, APR 18, 2016, View Source [SID:1234510996]).

Pre-clinical Oral Presentation:
· Title: Optimization of IL13Rα2-specific CAR T cells for Clinical Development Using Orthotopic Human Glioblastoma Models in NSG Mice
o Abstract Number: 275
o Session: Oral Abstract Session 243 – Cancer-Immunotherapy, Cancer Vaccines I
o Date and Time: Thursday, May 5, 2016; 4:00 – 5:45 PM ET
o Location: Marriott Wardman Park Hotel, Washington 4
o Presenter: Dr. Christine Brown, Associate Director, T cell Therapeutics Research Laboratory at the City of Hope Medical Center ("COH")

Clinical Oral Presentation:
· Title: Phase I Study of Second Generation Chimeric Antigen Receptor–Engineered T cells Targeting IL13Rα2 for the Treatment of Glioblastoma
o Abstract Number: 247
o Session: Scientific Symposium 201 – Clinical Trials Spotlight
o Date and Time: Thursday, May 5, 2016; 8:00 AM – 10:00 AM ET
o Location: Marriott Wardman Park Hotel, Thurgood Marshall NE
o Presenter: Dr. Benham Badie, Vice Chair and Professor, Department of Surgery, Chief, Division of Neurosurgery, Director, Brain Tumor Program and Neurosurgeon at the City of Hope Medical Center ("COH")

Copies of the above referenced abstracts can be viewed online through the ASGCT (Free ASGCT Whitepaper) meeting website at View Source

About Glioblastoma multiforme (GBM)
Glioblastomas (GBM) are tumors that arise from astrocytes—the star-shaped cells that make up the supportive tissue of the brain. These tumors are usually highly malignant (cancerous) because the cells reproduce quickly and they are supported by a large network of blood vessels. GBM is the most common brain and central nervous system (CNS) malignancy, accounting for 15.1% of all primary brain tumors, and 55.1% of all gliomas. There are an estimated 12,120 new glioblastoma cases predicted in 2016 in the U.S. Malignant brain tumors are the most common cause of cancer-related deaths in adolescents and young adults aged 15-39 and the most common cancer occurring among 15-19 year olds in the U.S. (Brain Tumor Statistics. American Brain Tumor Association. December 2015). While GBM is a rare disease (2-3 cases per 100,000 person life years in the U.S. and E.U.), it is quite lethal with 5-year survival rates historically less than 10%. Chemotherapy with temozolomide and radiation are shown to extend mean survival from ~12 to ~15 months, while surgery remains the standard of care. GBM remains difficult to treat due to the inherent resistance of the tumor to conventional therapies. Treatment is further complicated by the susceptibility of the brain to damage, difficulty of the brain to repair itself and limitation to drugs crossing the blood brain barrier. Immunotherapy approaches targeting brain tumors offer promise over conventional treatments.

About MB-101 (IL13Rα2-specific CAR-T cells)
IL13Rα2 is an attractive target for CAR-T therapy as it has limited expression in normal tissue but is over-expressed on the surface of the majority of GBM. CAR-T cells designed to express a membrane-tethered IL-13 receptor ligand (IL-13) incorporating a single point mutation display high affinity for IL13Rα2 and reduced binding to IL13Rα1 in order to reduce healthy tissue targeting.

We are developing an optimized CAR-T product incorporating enhancements in CAR design and T-cell engineering to improve antitumor potency and T-cell persistence. We include a second generation hinge optimized CAR containing mutations in the IgG4 linker to reduce off target Fc interactions, as well as the 41BB (CD137) co-stimulatory signaling domain for improved survival and maintenance of memory T-cells, and extracellular domain of CD19 as a selection/safety marker. In order to further improve persistence, memory T-cells are enriched and genetically engineered using a manufacturing process that limits ex vivo expansion in order to reduce T-cell exhaustion and maintain a memory T-cell phenotype.

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