Mustang Bio Inc. (NASDAQ:MBIO) has announced preliminary results of its ongoing phase 1/2 MB-106 clinical trial. MB-106 is a CD20-targeted autologous CAR T cell therapy the company is developing in partnership with Fred Hutchinson Cancer researcher Centre for treatment of refractory/relapsed B-cell non-Hodgkin lymphoma (NHL) patients.
Mustang presents MB-106 study data at ASH meeting
Associate Professor Mazyar Shadman, Clinical Researcher Division of Fred Hutch, presented the data at the Annual 62ns American Society of Haematology (ASH) meeting. The presentation included safety data from the original and modified cell manufacturing processes and efficacy day from the modified process. There was a favorable safety profile observed after 28 days of evaluation in all the 16 patients without an immune effector cell-related neurotoxicity syndrome. Only two patients experienced cytokine release syndrome with a single grade 3 occurrence in form of unexplained alkaline phosphatase elevation in a fever setting in a patient treated before cell process modification.
Equally the overall response rate was 89% with a complete response rate being 44% in nine patients who received modified process treatment. Interestingly, in follicular lymphoma patients, the overall response rate was 85% with a complete response of 57%.
Shadman said that they are delighted to observe a favorable safety profile with complete and partial responses in the modified cell manufacturing process for MB-106. Most importantly as of the ASH presentation date, all complete responders were still in remission.
Mustang to file IND for MB-106 in Q1 2021
The company’s CEO Manuel Litchman said that the preliminary data presented at the ASH meeting shows a favorable safety profile with compelling clinical activity demonstrated by MB-106 in r/r B-cell NHL. Litchman said that the responses observed in patients that received modified cell manufacturing process treatment are highly encouraging. He said that the company is looking forward to advancing the CD20-targeted CAR T cell therapy.
Mustang will file an Investigational New Drug in Q1 2021 to enable it to initiate a multi-center second phase MB-106 trial. The company is currently enrolling CD20+ NHL patients in the on-going phase 1/2 study which is modified to include chronic lymphocytic leukemia patients.