Mustang Bio Takes Manufacturing to the Next Level with Strategic Partnership and Updated Portfolio

Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO) has taken action to further its vision of developing groundbreaking cell and gene therapies to combat difficult-to-treat cancers and rare genetic diseases.

By optimizing the allocation of its resources and entering into a strategic partnership with uBriGene (Boston) Biosciences Inc., Mustang intends to help realize its ambitions and milestones for 2023.

This partnership includes the sale of the Company’s Worcester, Massachusetts facility, where the development, manufacturing and analytical testing of these revolutionary therapies will take place. Through this collaboration, Mustang and uBriGene will collaborate together to advance and develop treatments using Mustang’s MB-106, MB-109, and in vivo CAR T platform technology.

Mustang and uBriGene have reached an agreement under which uBriGene will acquire Mustang’s state-of-the-art cell and gene therapy manufacturing facility, located in Worcester, Massachusetts, for a total consideration of $11 million.

This includes a payment of $6 million upon closing, plus an additional $5 million in relation to Mustang raising $10 million from equity raises, post-closing. Provided certain conditions are met, including the approval of transfer of the company’s lease and acceptance of offers of employment, the deal should be concluded by June 2023.

Upon concluding this agreement, uBriGene will take on the responsibility of manufacturing Mustang’s lead product candidates and supporting MB-106 manufacturing for the ongoing multi-center Phase 1/2 trial. This manufacturing supply agreement will be a great collaboration that positions both parties to succeed.

uBriGene is excited to tap into Mustang’s experienced staff and sophisticated quality and operating systems to manufacture a wide range of advanced therapy products, from process development to commercial production!

Our Worcester facility, a 27,000 square foot cGMP facility, is designed to meet various cell and gene therapy production needs and capacities. Moreover, uBriGene will provide preclinical research services and late-stage and commercial manufacturing services, including product and process characterization and regulatory inspections.

Mustang Bio is delighted to announce its new partnership with uBriGene, which will accelerate production of its CAR T cell and gene therapies. We are grateful to our manufacturing team in Worcester for their commitment since 2018, and we are delighted to have the chance to work together in new capacities as a CDMO. With the help of this strategic alliance, we are able to reach key data milestones and extend our cash runway.

uBriGene is proud to announce its acquisition of the University of Massachusetts Chan Medical School’s cell and gene therapy manufacturing facility, strengthening its long-term commitment to develop, manufacture, and commercialize promising cell and gene therapy treatments for patients.

In addition to increasing uBriGene’s presence in North America, this partnership will benefit the Greater Boston biotechnology community and has already enabled them to provide support for Mustang Bio’s lead CAR-T program. Achieving successful results in the field of cell and gene therapy has never been more accessible.

Mustang Bio Strategic Portfolio Updates

CAR T Cell Therapies

Mustang has made the strategic decision to discontinue development of MB-102, its CD123-targeted CAR T cell therapy, along with its HER2, CS1, and PSCA-targeted CAR T cell therapies — a portion of the Company’s partnership with City of Hope.

After careful consideration of its product candidates and a thorough evaluation of the proper allocation of resources, Mustang has determined these programs to no longer be viable in its pipeline.

Mustang will stay committed to furthering the development of MB-106 (CD20-targeted CAR T cell therapy) with Fred Hutch, as well as its in vivo CAR T platform technology in collaboration with Mayo Clinic.

Together with City of Hope and Nationwide Children’s Hospital, the company is dedicated to furthering the potential of MB-109 (MB-101 CAR T cell therapy targeting IL13Rα2 on malignant glioma cells + MB-108 oncolytic virus) to effectively render tumors more susceptible to destruction by the CAR-T cells.

Gene Therapies

Mustang Bio has decided to put a pause on enrolling in investigator-sponsored clinical trials of the gene therapy for X-linked severe combined immunodeficiency (“XSCID”). The company is taking this precautionary measure in anticipation of new trials testing a modified version of the current lentiviral vector.

Thus far, no safety concerns or insertional mutagenesis or malignancy have been noted and, for the time being, Mustang will be utilizing the safest available vector and redirecting its near-term operating expenses. The company will provide more information on timelines after examining the data from these additional trials.

In 2023, we look forward to an exciting opportunity to treat a second RAG1-SCID patient with our MB-110 LV-RAG1 ex vivo lentiviral gene therapy as part of our ongoing Phase 1/2 multicenter clinical trial in Europe.

Additionally, our research collaboration with Leiden University’s Frank J. Staal, Ph.D. holds potential for developing further lentiviral gene therapies, and we eagerly anticipate providing updates on this project soon.

Mustang has conducted a thorough and strategic review of its CAR T and gene therapy portfolio and determined that its resources should be most effectively allocated to benefit its lead clinical-stage CAR T programs, which could potentially provide curative treatments for certain hematological cancers and solid tumors.

Currently, MB-106 is demonstrating impressive efficacy and a favorable safety profile in a Phase 1 investigator-sponsored trial at Fred Hutch, with an overall response rate of 96% and a complete response rate of 75% across a wide range of hematological malignancies, including Waldenstrom macroglobulinemia.

As a result, Mustang plans to expand MB-106’s trial to treat patients with WM to expedite a fast-to-market Phase 2 strategy, with the first pivotal Phase 2 WM patient potentially to be treated by the start of 2024.

Furthermore, the data from Fred Hutch indicates that MB-106 could potentially be administered as an outpatient therapy to provide an optimal immunotherapy option for those who have already been treated with CD19-directed CAR T cell therapy.

Mustang is looking forward to presenting further data from the Fred Hutch clinical trial in the second quarter of 2023 as well as learning of initial results from its multicenter clinical trial in the near future.

Additionally, MB-101 at City of Hope and MB-108 at the University of Alabama at Birmingham are both currently enrolling patients with recurrent GBM, and Mustang is planning to file an IND for its pre-clinical program MB-109 sometime in 2021.

By maximizing its resources and postponing the launch of other pivotal trials, Mustang ensures that it is well-resourced to support the development of its current products and expedite the achievement of various upcoming milestones for cancer care.

General Corporate

Mustang is investing in its future with a transaction that will incur severance charges of $2.1 million but bring in future annualized savings of $24 million from increased efficiency in personnel, facility and clinical operations, as well as better managing its portfolio of development projects.

Additionally, the Company has repaid and terminated its Loan and Security Agreement with Runway Growth Finance Corp., freeing up an estimated $4.3 million in annual interest expense in April 2023.

About uBriGene (Boston) Biosciences Inc.

At uBriGene Biosciences Inc. in Boston, we are redefining CDMO services by offering one-stop, integrated solutions and innovative biologics platforms for research and clinical applications. Our cutting-edge GMP facilities provide large-scale CAR-T production services and a range of viral vectors including adenoviral and lentiviral vectors.

Our fermentation capacities reach up to 500L, and we offer research-grade, GMP-ready, or GMP-grade plasmids to fit the needs of every project. Showcased across our 133,000 sq ft of clean suites, see for yourself how uBriGene’s commitment to quality and our reliable service can do more for your project.

About Mustang Bio

Mustang Bio, Inc. is a clinical-stage biopharmaceutical company dedicated to revolutionizing the medical world with cutting edge cell and gene therapies. Our mission is to bring potential cures for hematologic cancers, solid tumors and rare genetic diseases to the masses by acquiring rights to them, funding research and development, and outlicensing or bringing the technologies to market.

In collaboration with the top medical institutions, Mustang is leading the charge in advancing the development of CAR-T therapies to a wide range of cancers, as well as lentiviral gene therapies for severe combined immunodeficiency. As a publicly traded company registered under the Securities Exchange Act of 1934, Mustang files periodic reports with the SEC. We are founded by Fortress Biotech, Inc. (Nasdaq: FBIO).

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