- The stock price of Mustang Bio Inc (NASDAQ: MBIO) increased by over 7% pre-market. These are the details.
The stock price of Mustang Bio Inc (NASDAQ: MBIO) increased by over 7% pre-market. Investors are responding positively to Mustang Bio announcing updated interim data from the ongoing Phase 1/2 clinical trial investigating the safety and efficacy of MB-106 CD20-targeted, autologous CAR T cell therapy for high-risk B-cell non-Hodgkin lymphomas (B-NHL) and chronic lymphocytic leukemia (CLL). And MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Research Center.
The data presented in an e-poster session at the European Hematology Association 2021 Virtual Congress (EHA2021) by Mazyar Shadman, M.D., M.P.H., Associate Professor, Clinical Research Division of Fred Hutch, included safety and efficacy data from the cell manufacturing process that was modified to combine the culture of CD4+ and CD8+ cells. In the 15 patients treated, the overall response rate was 93% (14/15) with a complete response (CR) rate of 67% (10/15).
In 11 patients with follicular lymphoma, ORR, and CR were 91% (10/11) and 82% (9/11), respectively. As of the time of the e-poster submission to EHA2021, all patients who achieved CR remained in remission.
And one patient with FL had an initial partial response with a later disease progression, had a spontaneous CR, and remains in remission. The patient with CLL also had a CR and undetectable measurable residual disease in peripheral blood and bone marrow by flow cytometry (10-4) (uMRD4) on day 28. CAR T persistence was seen in all dose levels (DL) and, while the expansion was faster in higher DL, the levels were comparable by day 28.
Based on a safety profile perspective, cytokine release syndrome (CRS) occurred in 6 patients (40%): 3 patients with grade 1 and 3 patients with grade 2. Only 1 patient (6.5%) experienced grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) and none of the 11 patients with FL experienced ICANS of any grade. No grade 3 or higher CRS or ICANS were seen in any patient.
“MB-106 continues to demonstrate a very favorable safety and efficacy profile, as well as sustained complete responses. This compelling clinical activity, including the complete remissions in 67% of the patients in the trial, demonstrates the potential of MB-106 as a viable CD20-targeted CAR T cell therapy. We are pleased that all complete responders continue to remain in remission, and we continue to enroll all eligible CD20+ NHL and CLL patients into this trial.”
— Dr. Mazyar Shadman, M.D., M.P.H., Associate Professor, Clinical Research Division of Fred Hutch
“We are encouraged by the updated MB-106 safety and efficacy data presented by Dr. Shadman today. As reported last month, the FDA has accepted Mustang’s IND application to initiate a multicenter Phase 1/2 clinical trial investigating the safety, tolerability and efficacy of MB-106 for relapsed or refractory B-NHL and CLL. We look forward to commencing the trial later this year and further advancing MB-106 for patients with B-NHL and CLL who are in need of new treatment options.”
— Manuel Litchman, M.D., President and Chief Executive Officer of Mustang
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.