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Autolus Autolus Therapeutics Reports Third Quarter 2021 Financial Results and Operational Progress November 3 , 2021 Conference call to be held on November 3 , 2021 , at 8:30 am ET / 12 : 30 pm GMT LONDON , Nov. 03 , 2021 ( GLOBE NEWSWIRE ) -- Autolus Therapeutics plc ( Nasdaq : AUTL ) , a clinical - stage biopharmaceutical company developing next - generation programmed T cell therapies , today announced its operational and financial results for the third quarter ended September 30 , 2021 . " We continue to make good progress on the clinical evaluation of obe - cel in the Phase 2 portion of the FELIX study and remain on track to deliver primary endpoint data in the middle of 2022. We are also pleased to update that the response rate and safety data from patients in the multi - center Phase 1b cohort are consistent with the data reported from the academic ALLCAR19 study of obe - cel in relapsed / refractory adult B - acute lymphoblastic leukemia ( ALL ) , " said Dr. Christian Itin , chief executive officer of Autolus . " In addition , we expect a busy end of the year with clinical data at the upcoming 63rd Annual Meeting of the American Society of Hematology ( ASH ) , including an oral presentation , where we will provide early clinical data from the Phase 1b trial , as well as a poster presentation covering clinical data from the ALLCAR19 extension trial and a poster with initial clinical data for AUTO1 / 22 . " Key Pipeline Updates : • Obecabtagene autoleucel ( obe - cel ) in relapsed / refractory ( r / r ) adult ALL . - • FELIX Study Autolus continues to enroll patients in the Phase 2 portion of the FELIX study . The multi - center study is progressing well , with consistent one - month complete response rate and safety data observed from the initial 16 patients in the Phase 1b cohort as compared to data reported from the academic ALLCAR19 study of obe - cel in r / r adult ALL . Autolus expects to present early clinical data from the Phase 1b portion of the FELIX trial at the 63rd ASH Meeting in December 2021. The Company reiterates its expectation of pivotal data in 2022 . • ALLCAR19 Study - Data were published in the Journal of Clinical Oncology ( JCO ) in September 2021 from the ALLCAR19 trial in r / r adult ALL patients . Obe - cel demonstrated a manageable adverse events profile , with no patients experiencing high grade ( ≥ grade 3 ) cytokine release syndrome ( CRS ) , despite the majority having a high disease burden prior to lymphodepletion¹ . CAR T cell concentration reached very high levels at peak ( mean peak CAR T concentration ( Cmax ) by quantitative polymerase chain reaction ( qPCR ) was 127,152 copies / µg genomic DNA¹ ) and persistence in peripheral blood was evident in 15/20 ( 75 % ) patients at a median of 166.5 days , with 4/20 ( 20 % ) patients having follow - up duration over 2 years , and 3/4 of these patients with ongoing CAR persistence at the data cut - off date of February 26 , 20211. B - cell aplasia was ongoing in 15/20 patients at the last observation date of February 26 , 20211. Of the 20 patients , 85 % patients achieved minimal residual disease ( MRD ) negative complete response ( CR ) at month 11. Duration of response remains highly encouraging . With a data cut - off date of May 17 , 2021 , and as presented at the European Hematology Association ( EHA ) Virtual Congress in June 2021 , event free survival ( EFS ) at 12 months and 24 months was 50.2 % , with median EFS not reached across all patients treated² . 1 Roddie et al . " Durable responses and low toxicity after fast off - rate CD19 CAR - T therapy in adults with relapsed / refractory B - ALL . " DOI : 10.1200 / JCO.21.00917 Journal of Clinical Oncology - published online before print August 31 , 2021 2Roddie et al . " Early Safety and Efficacy Findings of AUTO1 ( CAT19 ) , a Fast - Off Rate CD19 CAR , in Relapsed / Refractory Indolent B Cell Lymphomas . " EHA annual meeting , June 11 2021 , abstract EP788 . EHA Investor slide presentation • Obe - cel in r / r B - NHL - ALLCAR19 extension • The latest data of obe - cel were presented by Autolus at EHA in June 2021 in r / r B - NHL ( Follicular Lymphoma and Mantle Cell Lymphoma ) patients . The trial is progressing well and Autolus plans to present updated data from the ALLCAR extension trial at the ASH Meeting in December 2021 . • AUTO4 in Peripheral T Cell Lymphoma • The AUTO4 Phase 1 clinical trial is progressing through dose escalation and Autolus expects to provide its next data update from the trial in the first half of 2022 . • AUTO8 in Multiple Myeloma • The Company is on track to start a Phase 1 trial in the fourth quarter of 2021 . Operational Highlights :