uBriGene Expands into US Market with Acquisition of Mustang Bio's CGT Manufacturing Facility

Mustang Bio, a US-based clinical-stage biopharmaceutical company, announced on May 18, 2023 that it has entered into an agreement with uBriGene Biosciences, the US subsidiary of uBriGene Group, a China-based cell and gene therapy (CGT) contract development and manufacturing organization (CDMO). According to the terms, uBriGene will acquire Mustang Bio’s commercial-scale CGT development, manufacturing, and analytical testing facility in Worcester, Mass.

Under the agreement, uBriGene will acquire the Worcester facility for a total consideration of $11 million, which includes a $6 million upfront payment plus an additional $5 million payable upon Mustang raising $10 million in equity after the close of transaction. The transaction is expected to close in June 2023 dependent on closing conditions.

Also under the agreement, and subject to closing, uBriGene and Mustang will enter into a manufacturing supply agreement, under which uBriGene will manufacture Mustang’s lead product candidates. According to a uBriGene company press release, uBriGene will also take over the clinical manufacturing of MB-106, Mustang’s chimeric antigen receptor T cell (CAR-T cell) therapy for treating a wide range of hematologic malignancies, including Waldenstrom macroglobulinemia, a rare malignant disorder of the bone marrow and lymphatic tissues. According to a Mustang company press release, uBriGene will continue to support MB-106 manufacturing for the duration of an ongoing multi-center Phase I/II trial.

The Worcester facility is a 27,000 ft² current good manufacturing practice-compliant facility that supports process development, manufacturing, and analytical testing of CGTs. It is designed to be flexible and to expand and support various CGT production requirements and capacities. uBriGene intends to expand the site’s capabilities to manufacture a broader portfolio of advanced modalities with the help of Mustang’s experienced staff and robust quality and operating systems. According to Mustang’s company press release, uBriGene will also offer its expertise in preclinical research services and late-stage and commercial manufacturing of advanced therapy products; in particular, uBriGene will bring to bear its expertise in product and process characterization as well as regulatory inspections.

“We are very pleased to have found a great partner for the manufacturing of our CAR-T cell and gene therapies, and we believe that this strategic partnership with uBriGene will meet our portfolio manufacturing needs to reach critical upcoming data inflection points, while extending our cash runway. I want to thank our manufacturing team for their dedication in building and growing our Worcester facility since it opened in 2018. While we are optimizing our resources at Mustang, we look forward to continuing to work with many of our colleagues in this new capacity, as our CDMO,” said Manuel Litchman, president and CEO of Mustang, in that company’s press release.

“This acquisition is important to uBriGene’s commitment to support the development, clinical, and commercial supply of cell and gene therapies to sustain industry demand and provide new CDMO options,” said Alex Chen, president of uBriGene, also in the Mustang release. “We look forward to working together with the University of Massachusetts Chan Medical School and local biotechnology companies to continue to advance the manufacturing ecosystem in the Greater Boston region. This partnership enables us to expand rapidly to create a North American presence and offer the same high-quality cell and gene therapy development and manufacturing capabilities for the U[nited] S[tates] that we currently provide in Asia, including to support Mustang Bio’s lead clinical-stage CAR-T program.”

Source: Mustang Bio and uBriGene