Autolus Therapeutics to present clinical data updates at ASH meeting

Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the online publication of three posters with updates from three Phase 1 clinical trials to be presented at the American Society of Hematology Annual Meeting, December 10-13, 2022. Posters to be presented: Title: Safety, Efficiency and Long-Term Follow-up of AUTO1, a Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia and Other B-Cell Malignancies. Summary: In the B-ALL cohort, 7 out of 20 patients were observed to be in ongoing Complete Remission at median follow up of 36 months post-AUTO1 without the need for additional anti-leukemia therapy. Ongoing long-term remissions appear to be associated with CAR-T persistence, which was also observed in these 7 patients at their last follow-up. One patient with a subsequent stem cell transplant also achieved long term remission but lost CAR T persistence after SCT. In the B-cell non-Hodgkin lymphoma/chronic lymphocytic leukemia cohorts, AUTO1 continues to display a favorable tolerability profile with no immune effector cell-associated neurotoxicity syndrome or Grade greater than or equal to 3 cytokine release syndrome across different indications. Of 25 patients with NHL/CLL evaluable for efficacy, the best overall response rate was 23/25. AUTO1 was observed to be well-tolerated and active in diffuse large B-cell lymphoma, with 7 of 8 patients in ongoing CR at last follow-up. In CLL, 4 of 5 treated patients achieved undetectable minimal residual disease in the bone marrow, ongoing at last follow-up. While no relapses were seen in DLBCL patients, late CD19+ relapses were seen in follicular lymphoma, and ongoing CAR-T persistence appears to be important. Title: Dual Antigen Targeting with Co-Transduced CD19/22 CAR T Cells May Prevent Antigen-Negative Relapse after CAR T Cell Therapy for Relapsed/Refractory ALL: Summary: AUTO1/22 demonstrated a strong level of activity with 83% MRD negative complete remissions and a favorable tolerability profile in a very challenging patient population. AUTO1/22 showed excellent expansion, with a median 7.5 months duration of persistence of CD22 CAR. No antigen negative relapse was seen in responding patients. At a median follow up of 8.7 months, five of 10 responding patients were in MRD negative complete response with two after further therapy for early loss of CAR T persistence. Title: First in Human Study of AUTO4, a TRBC1-Targeting CAR T-Cell Therapy in Relapsed/Refractory TRBC1-Positive Peripheral T-Cell Lymphoma: Summary: Having shown proof of concept at EHA in June 2022, AUTO4 treatment for peripheral T-cell Lymphoma continues to be observed to be well tolerated with no dose-limiting toxicities. Ongoing responses at 9- and 12-months post-dosing at the highest dose tested are encouraging, and suggests a potential clinical benefit for patients. No CAR T cell expansion was observed in peripheral blood, but CAR T cells were detected in an on-treatment lymph node biopsy. Optimization of the AUTO4 manufacturing process has been performed, resulting in a product candidate with a more naive and central memory phenotype. The study is ongoing, with additional patients due to be treated to define the recommended Phase 2 dose.