Mustang Bio Announces Expansion into CAR T-cell Therapy for Autoimmune Diseases

Mustang Bio has been developing MB-106, an autologous chimeric antigen receptor (CAR) T-cell therapy, in collaboration with Fred Hutch Cancer Research Center for 7 years. The program began with an investigator-sponsored phase 1 trial at Fred Hutch, which recently completed enrollment of its 50th and final patient.

In part 1 of an interview with HCPLive, Manuel Litchman, MD, president and CEO of Mustang Bio, discusses their recent foray into the autoimmune space.

They initiated a multicenter trial, including 6 centers, to replicate the data from a single-center trial and expand into additional indications not initially included in the single center study at Fred Hutch.

Additionally, ensuring their own manufacturing capability was crucial for US Food and Drug Administration (FDA) compliance. They have successfully manufactured cells for every patient in these multicenter trials, ensuring consistent results across different malignancies. From a safety perspective, they have had no grade 3 or higher cytokine release syndrome or immune effector cell-associated neurotoxicity.

“In fact, it's been so safe that most of our 6 centers are equipped to be able to do administer this as an outpatient,” Litchman explained. “The protocol is written as outpatient therapy, with the exception of in dose escalation, which means a quick reinfusion of the cells, 4 hours of observation and then [patients can] go home.”

Litchman reiterated the program has been successful both in terms of safety and efficacy, as demonstrated by various posters presented at conferences including the American Society of Hematology (ASH).

He and his team are now positioned to explore the potential of MB-106 in autoimmune diseases, leveraging their extensive experience and robust database of 70 patients (50 at Fred Hutch and 20 at Mustang Bio). Despite financial considerations, the collaboration with Fred Hutch has enabled Mustang Bio to conduct an investigator-sponsored trial to evaluate MB-106's efficacy and safety in autoimmune diseases, tapping into a significant market opportunity while ensuring financial viability for the company.

Disclosures: Litchman is the CEO of Mustang Bio.