- Mustang Bio's CAR-T manufacturing facility is up and running, with its first order of business to produce clinical supply of the company's three most advanced pipeline candidates.
- The 27,000-square-foot facility is located at the University of Massachusetts' Medicine Science Park in Worcester. Mustang signed a lease for the space at the end of October, and anticipates it will support clinical development, commercialization and proprietary cell therapy research.
- Before the end of the year, Mustang expects to start processing patient cells as well as file its first Investigational New Drug application for MB‐102, a potential therapy for acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm.
The industry's investment in chimeric antigen receptor T cell therapies, better known as CAR-Ts, has grown as scientific breakthroughs and supply chain improvements made it a more feasible business.
Celgene and Gilead Sciences each dropped billions of dollars last year to acquire biotechs focused on these treatments. The latter company's bet was met with some quick returns too, as Yescarta (axicabtagene ciloleucel) secured U.S. approval soon after Gilead's purchase. Sales to date have been modest relative to expectations, with the therapy fetching $40 million during its first full quarter on the market.
Despite such strides, the CAR-T landscape still has its obstacles. Manufacturing, for example, remains complex and expensive even by big pharma standards.
That can be particularly troublesome for smaller drugmakers. Mustang, however, benefits from a healthy amount of capital — $55 million in cash, cash equivalents and short-term investments as of March 31 — and from its relationship with parent company Fortress Biotech. And now, it has a production facility of its very own.
"[E]stablishing in‐house cell therapy research capabilities will enable us to continue to differentiate our product candidates through innovation in cell processing and the evaluation of immuno‐oncology technologies, like checkpoint antibodies and oncolytic viruses, in combination with our CAR Ts," company CEO Manuel Litchman, said in a June 22 statement.
Those research capabilities will initially be put to the test on a trio of Mustang candidates: MB-101, MB-102 and MB-106. Respectively, they target glioblastoma, acute myeloid leukemia, blastic plasmacytoid dendritic cell neoplasm, and B‐cell non‐Hodgkin lymphoma.