Source: UMass Medical School
Source: UMass Medical School

Cancer immunotherapy developer Mustang Bio has agreed to lease space within UMass Medicine Science Park in Worcester, MA, for a manufacturing facility intended to support the clinical development and commercialization of the company’s chimeric antigen receptor T-cell (CAR-T) product candidates.

Mustang Bio, a subsidiary of Fortress Biotech, will lease 27,043 square feet at the park through November 2026, subject to two additional extensions for five years each at Mustang’s option, the company stated in a regulatory filing.

In the filing, Mustang Bio disclosed that its base rent over the lease term will total approximately $3.6 million, net of $0.6 million in abatements, on a “triple-net” basis in which the company agrees to pay all real estate taxes, building insurance, and maintenance.

The new facility will be located within the research park’s 93,000-square-foot Four Biotech office and laboratory building, the Worcester Telegram & Gazette reported.

The company said it initially expects to build cell-processing capabilities at the new facility, in order to support its two lead CAR-T product candidates, the glioblastoma multiforme treatment MB-101 and MB-102, which is being developed for both acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm.

MB-101 targets interleukin-13 receptor subunit alpha-2 (IL13Rα2), which according to Mustang has limited expression in normal tissue but is overexpressed on the surface of greater than 50% of glioblastomas. The company’s CAR T cells are designed to express membrane-tethered IL-13 receptor ligand with high affinity for IL13Rα2 and reduced binding to IL13Rα1 in order to reduce healthy tissue targeting.

MB-102 targets CD123, a subunit of the heterodimeric interleukin-3 receptor (IL-3R) that is widely expressed on human hematologic malignancies, including AML. Mustang says it is investigating CD123 as a target for adoptive cellular immunotherapy in AML, since high CD123 expression is associated with enhanced AML blast proliferation, increased resistance of blasts to apoptosis, and poor clinical prognosis.


Ongoing Phase I Trials

Both candidates are in ongoing Phase I trials being conducted at City of Hope National Medical Center. MB-101 is being assessed in an ongoing Phase I clinical study to assess the feasibility and safety of using central memory T-cell-enriched IL13Rα2-specific CAR engineered T cells on patients with recurrent/refractory glioblastoma. MB-102 is being assessed for antitumor activity and safety in patients with AML.

For both candidates, the company states on its website, “We will assess the T-cell persistence and determine the potential immunogenicity of the cells to determine a recommended Phase II dose.”

Mustang Bio said it expects the new facility to be operational for clinical production in mid 2018.

“We are thrilled to announce this important milestone, which lays the foundation for the clinical development and potential commercialization of our CAR-T pipeline, and may expedite manufacturing innovations to improve patient outcomes,” Mustang Bio president and CEO Manuel Litchman, M.D., said in a statement.

By locating its manufacturing facility near the top-tier Boston/Cambridge, MA, cluster, Mustang Bio also reasons that the UMass location may enable it to recruit top-notch manufacturing talent. The company already maintains an office in another Boston/Cambridge suburb, Waltham, MA.

The manufacturing facility lease marks Mustang Bio’s latest move toward expansion. In February, Mustang raised $94.5 million through a private placement, with proceeds intended to advance the two lead CAR-T immunotherapies through Phase I data readout, and expand the company’s pipeline by exploring additional applications for the CAR-T technology in areas outside of brain cancer and AML.

Today, Mustang said it published positive preclinical results for MB-103, a second-generation HER2 CAR-T therapy, in Clinical Cancer Research, a journal of the American Association for Cancer Research. City of Hope conducted the preclinical study, whose data showed effective targeting of breast cancer brain metastases with intraventricular delivery of HER2-BBζ CAR T cells, and according to Mustang support the clinical development of the therapy.

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