The launch of the facility looks set to allow the New York-headquartered biotech to manufacture its own therapies in-house ahead of filing investigational new drug (IND) applications, slated for late 2018, for its lead chimeric antigen receptor (CAR) T-cell drug candidate MB-102, for the treatment of acute myeloid leukaemia and blastic plasmacytoid dendritic cell neoplasm.
Coinciding with the IND applications, the company announced it expects the facility to be ready to process and produce CAR T therapies from patients’ cells by the end of 2018.
Manuel Litchman, CEO of Mustang, said of the facility’s opening in a statement: “Establishing 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.”
BioPharma-Reporter reached out to Mustang for comment on how the biotech would differentiate its CAR T products in the rapidly emerging market, currently dominated by Novartis’ Kymriah and Gilead’s Yescarta.
In response, the company referred to a presentation that suggested ways in which its prospective treatments will be able to find a niche on the market; the presentation highlighted the company has a focus on engineering the CAR molecules (for example, by humanisation of the scFv) and altering T cells by “knocking out PD-1” through the use of CRISPR technology.
According to the company, the facility cost less than $10m (€8.57m) to build and the location itself, in Massachussets, follows a larger trend for emerging biotechs to pursue locations close to the biotech hub of Boston and the surrounding area.
One area that is still of significant interest, as the nascent area of CAR T matures, is how quickly the treatments can be produced. Novartis, for instance, has publically stated that its aim is for a turnaround of 22 days from taking patient cells to delivering treatment. Mustang Bio did not comment on how quickly it will be able to produce its own therapies.
In regards to the biomanufacturing investment coming into the Worcester area, Jon Weaver, Chief Operating Officer for Massachusetts Biomedical Initiatives, commented to BioPharma-Reporter: "Worcester sees itself as the Western Anchor of the Massachusetts Biomedical Corridor between New England’s two largest cities. We’re experiencing a strong shift westward as companies seek lower costs and congestion, while retaining access to a strong workforce and Worcester’s 10 colleges and universities.
He continued, "The collaborative team in Worcester is actively complementing the growth of the cluster, and has recently focused on supporting biomanufacturing with the creation of the 44 acre Worcester Biomanufacturing Park in partnership with the Baker/Polito Administration Open for Business Program."