On November 2, 2023 Mustang Bio, Inc. ("Mustang") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, reported that interim Phase 1/2 data from Mustang’s multicenter clinical trial of MB-106, a CD20-targeted, autologous CAR-T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") and chronic lymphocytic leukemia ("CLL"), have been selected for a poster presentation at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting, taking place December 9-12, 2023 in San Diego (Press release, Mustang Bio, NOV 2, 2023, View Source [SID1234636778]). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center ("Fred Hutch").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The abstract posted today on the ASH (Free ASH Whitepaper) Annual Meeting website reported on four patients who received MB-106 at dose level 1 ("DL1"), 3.3×106 cells/kg: two patients with follicular lymphoma ("FL") who achieved complete response as demonstrated by both PET-CT and bone marrow biopsy, one patient with Waldenstrom macroglobulinemia ("WM") who achieved a very good partial response ("VGPR"), and one patient with transfusion-dependent hairy cell leukemia variant ("HCL-v") who continued to have stable disease with decreased bone marrow disease and who achieved complete transfusion independence which is ongoing at 6 months. All patients displayed MB-106 expansion, with peak levels between 7-14 days post-infusion, and CAR-T cell persistence is ongoing at 6 months. From a safety perspective, 3 patients experienced Grade 1 cytokine release syndrome and no occurrences of immune effector cell-associated neurotoxicity syndrome were reported. Dose-limiting toxicities ("DLT") were monitored through day 28, and no DLTs were observed at DL1. Because of this favorable safety profile, MB-106 is infused in the outpatient setting if allowed by the institution, except for the first patient in each DL cohort, who is kept for overnight observation after MB-106 administration.

All four patients were heavily pre-treated, with a median of 5.5 prior lines of treatment. The WM patient in particular had nine prior treatments, including autologous stem cell transplant, and a high disease burden, and the patient’s VGPR was notable for complete metabolic response by PET-CT, morphologic clearance of lymphoma in bone marrow and resolution of the immunoglobulin M paraprotein. Other high-risk features were observed in each of the two FL patients: progression of disease within 24 months of first-line treatment in one patient and prior CD19-targeted CAR-T therapy in the other. Finally, the HCL-v patient received non-conforming material following FDA authorization.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We’re encouraged by the promising initial safety and efficacy data from our ongoing Phase 1/2 multicenter MB-106 clinical trial, which align with the data from the ongoing Phase 1/2 single-institution clinical trial at Fred Hutch. MB-106 continues

to demonstrate a favorable safety and efficacy profile, including complete responses from both trials in patients previously treated with CD19-targeted CAR-T cell therapy. In particular, we are excited about the very good partial response in WM, our lead indication for MB-106 and a disease where complete responses are extremely rare. We look forward to the upcoming presentation at the ASH (Free ASH Whitepaper) Annual Meeting, during which we anticipate sharing additional data from the Phase 1 indolent NHL arm, including all patients treated at the second and final dose level, 1×107 cells/kg, who have had at least 28-day follow-up. Looking beyond this meeting, we expect to treat the first patient in the pivotal Phase 2 WM trial in mid-2024, which could enable disclosure of top-line data from this trial as early as mid-2026."

Details of the presentation are as follows:

Title: Efficacy and Safety of a Third Generation CD20 CAR-T (MB-106) for Treatment of Relapsed/Refractory Indolent B-Cell Non-Hodgkin Lymphoma: Phase-1 Results from a Multicenter Trial

Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I

Date and Time: Saturday, December 9, 2023, 5:30 pm – 7:30 pm PT

Location: San Diego Convention Center, Halls G-H

Abstract Number: 2102

Presenter: Mazyar Shadman, M.D., M.P.H., Study Chair, Innovators Network Endowed Chair at Fred Hutch, Associate Professor and physician at Fred Hutch and University of Washington

For more information, please visit the 65th ASH (Free ASH Whitepaper) Annual Meeting and Exposition website at View Source