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Autolus Autolus Therapeutics Reports Second Quarter 2021 Financial Results and Operational Progress August 5 , 2021 - Conference call to be held on August 5 , 2021 at 8:30 am ET / 1 : 30 pm BST - LONDON , Aug. 05 , 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 quarter ended June 30 , 2021 . " We are very encouraged by the obe - cel data in adult acute lymphoblastic leukemia ( ALL ) and in B - cell non - Hodgkins Lymphoma ( B - NHL ) presented at the European Hematology Association ( EHA ) Virtual Congress in June . In adult patients with ALL , event - free survival stabilized at 50 % with 12 months follow up and was sustained at 24 months . These data indicate that obe - cel may be the first stand - alone therapy in adult ALL with curative potential in a last line setting . The FELIX trial is progressing well , and we expect pivotal data during 2022 , " said Dr. Christian Itin , chief executive officer of Autolus . " Additional data were presented at EHA for obe - cel in indolent B - NHL indicating a high level of clinical activity combined with a well manageable safety profile . Further data in patients with aggressive B - NHL and chronic lymphocytic leukemia ( CLL ) are expected by the end of the year . " Key Pipeline Updates : • Obe - cel in relapsed / refractory ( r / r ) adult B - Acute Lymphocytic Leukemia ( ALL ) . o Data presented at EHA in June 2021 from the ALLCAR19 trial in r / r adult ALL patients demonstrated that obe - cel was generally well tolerated , with no patients experiencing Grade 3 or higher cytokine release syndrome ( CRS ) . Three patients ( 15 % ) , all of whom had high leukemia burden ( > 50 % blasts ) , experienced Grade 3 immune effector cell - associated neurotoxicity syndrome ( ICANS ) that resolved swiftly with steroids . Of the 20 patients treated with obe - cel , 17 ( 85 % ) achieved minimum residual disease ( MRD ) -negative complete remission ( CR ) at one month . Most notably , as of the data cutoff date of May 17 , 2021 , the durability of remissions is encouraging . Across all treated patients , event free survival ( EFS ) at twelve months and twenty - four months was 50.2 % with median EFS not being reached . • Obe - cel in other relapsed / refractory B - NHL - ALLCAR19 extension ( Cohort D ) o Data presented at EHA in June 2021 in r / r B - NHL ( Follicular Lymphoma ( FL ) and Mantle Cell Lymphoma ( MCL ) ) patients demonstrated that , as of the data cut - off date of May 17 , 2021 , 9 r / r B - NHL patients ( 7 FL , 2 MCL ) infused with obe - cel achieved a complete metabolic remission and , apart from one , all evaluable patients remained in CR . Obe - cel has a tolerable safety profile in adult patients with r / r FL and MCL , despite high disease burden . Grade 1 CRS was reported in 4 patients and Grade 2 CRS in 1 patient . No ICANS of any grade was observed in the trial . • Obe - cel in high grade B - NHL and CLL - ALLCAR19 extension ( Cohorts B & C ) o The ALLCAR extension trial also involves two cohorts of patients with high grade B - NHL ( DLBCL ) and CLL . These cohorts are progressing well and Autolus plans to present updated data at the 63rd American Society of Hematology ( ASH ) Meeting in December 2021 . • Autolus received preferred regulatory access for obe - cel from UK Medicines and Healthcare products Regulatory Agency ( MHRA ) and European Medicines Agency ( EMA ) : • Autolus received an innovative licensing and access pathway ( ILAP ) designation from the MHRA for obe - cel being investigated in the ongoing FELIX trial in ALL . o Autolus received PRIority Medicines ( PRIME ) designation from the EMA . • These designations are designed to accelerate the review of a promising therapy targeting an unmet medical need . Data from the FELIX trial is expected in 2022 , which , if positive , could enable Autolus to file for accelerated approval . • AUTO4 in Peripheral T Cell Lymphoma ( PTCL ) . • Autolus received ILAP designation from the MHRA for AUTO4 being investigated in PTCL . • AUTO4 Phase 1 clinical trial is progressing through dose escalation and Autolus expects to provide a next data update in the first half of 2022 . Operational Highlights :