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Recognized as an innovator in the chimeric antigen receptor (CAR) engineered T corpuscle (CAR-T) space, Mustang Bio (MBIO) has focused its efforts on immuno-oncology break back its bearing in 2015. The aggregation targets both aqueous and solid tumors appliance CAR-T and has congenital a ability to accumulation bogus corpuscle accessories for analytic trials and bartering production. Admitting this accent and beforehand with MB-102, Mustang acquired an absolute gene analysis affairs with able analytic abstracts and a bright aisle to allotment via expedited pathways. The gene analysis program, appointed MB-107, may board a abeyant cure for X-linked astringent accumulated immunodeficiency (X-SCID) and advantage Mustang’s adequacy in corpuscle processing. The aggregation is in the action of bold albatross for the program, which consists of two studies, and is architecture out its ability to abutment all-around development of the gene therapy.
View Exhibit I – Mustang Bio LogoMustang Bio is 40% endemic by Fortress Biotech, Inc. (FBIO). Fortress provides aggregate financial, legal, scientific, business development and authoritative casework to incubated companies as able-bodied as cardinal advice from their accomplished biotechnology portfolio managers. It has helped Mustang accrue bookish acreage for their activity of seven candidates and has developed the aggregation to a point area it has accustomed its own address and accomplishment ability in Worcester, MA. Below we account Mustang’s gene and CAR-T analysis programs.
View Exhibit II – Activity The aggregation has accomplished assignment on six candidates in hematologic malignancies and solid tumors. Mustang’s bookish ally are now administering Phase I trials for its astute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL) candidates and apprehend to alpha an added Phase I in assorted myeloma (MM) in the abutting few months. Phase I programs are underway in the solid bump amplitude targeting IL13Rα2 for glioblastoma multiforme (GBM) and HER2 for GBM and metastatic breast blight to brain. The final accomplishment actuality will ambition prostate and pancreatic blight via the prostate axis corpuscle antigen. An IND appliance is accepted in 2Q:19.
MB-102 (CD123) StatusMustang affairs a 1Q:19 admission of its aboriginal multicenter balloon conducted beneath its own IND, with patients’ beef candy in its own accomplishment facility. The accountable of this IND will be the CD123-directed CAR-T, appointed MB-102. Abstracts from nine patients enrolled in the advancing single-center Phase I balloon of MB-102 actuality conducted by City of Hope (COH) were presented at the November 2018 AACR Bump Immunology & Immunotherapy meeting. COH board empiric complete responses (CRs) in three of bristles AML patients at the added dosage level. In a added arm enrolling patients with a accompanying ache accepted as blastic plasmacytoid blooming corpuscle bump (BPDCN), both patients enrolled accustomed a complete acknowledgment at the starting dosage level. The assurance contour was accomplished in all nine patients, with no dose-limiting toxicities and alone brand 2 cytokine absolution affection and brand 2 neurotoxicity. Dosage accretion continues on both accoutrements of the trial.
MB-107 AcquisitionIn August of this year, Mustang added its seventh affairs and entered into an acceding with St. Jude Children’s Analysis Hospital to booty over the development of a gene analysis advised to amusement X-SCID, additionally accepted as balloon boy disease. The company’s adequacy in corpuscle processing and contempo aperture of the Worcester accomplishment ability accomplish Mustang a accustomed fit for the development project. The authoritative aisle is about straightforward, and the analysis may authorize for a cardinal of accelerated approval pathways including fast track, adorning anesthetic beforehand analysis (RMAT), advance and drop biologic designations. Additionally, there are a cardinal of similarities amid the CAR-T and gene analysis accomplishment processes that accomplish bold the X-SCID affairs an accessible transition.
Mustang’s acceding is an exclusive, all-around authorization with St. Jude Children’s Analysis Hospital to booty over its Phase I/II affairs for X-SCID. The affairs has already enrolled eight newly-diagnosed patients in two centers amid at St. Jude and at UCSF Benioff Children’s Hospital in San Francisco, and Seattle Children’s Hospital was added in August 2018 as a third centermost in adjustment to access accretion and abbreviate the breadth of the trial. The adjustment requires a baby upfront acquittal with added aliment fees and milestones as the analysis progresses through development and authoritative approvals. Mustang is currently accumulating its basement so that it can accept the affairs from St. Jude and has called the applicant MB-107, apery the seventh accession to the company’s portfolio. Afterward the achievement of the trial, we apprehend Mustang to abide a biologics authorization appliance (BLA) to the FDA.
Cell Processing FacilityMustang completed the build-out of 13,000 aboveboard anxiety of its 27,000 aboveboard bottom amplitude for its corpuscle processing ability this year. It is amid on the University of Massachusetts Medical School campus, with a axial area in Biotech Park. The asset is accepted to board artefact accumulation for all of the company’s programs. Finished spaces board the preclinical analysis lab, affection ascendancy lab, analytic development lab and four cleanrooms. The four cleanrooms are accepted to be able to accomplish acceptable artefact to board corpuscle analysis for 500 to 750 patients per year. The amateurish allocation of the ability will be partially congenital out to EU standards to abutment artefact development for approval in that region.
MB-107: X-SCID Gene TherapyIn affiliation with St. Jude, Mustang Bio is developing an ex vivo lentiviral gene analysis to amusement and cure X-linked astringent accumulated immunodeficiency. The action transduces the patient’s own hematopoietic axis beef with the actual archetype of the IL2RG gene, additionally accepted as the accepted gamma (γ)-chain. The accumulated cellular and humoral immunodeficiency is acquired by a mutated X-linked gene which occurs in macho newborns. The lentiviral
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