Exhibit 99.1
Initial Results from Autolus Therapeutics’ ALLCAR19 Phase 1/2 Trial in Adult
Acute Lymphoblastic Leukemia Presented at the AACR Annual Meeting
Initial results from the trial show 88% molecular complete response at one month with well-tolerated safety profile
Management to Hold Conference Call on April 2, 2019 at 8:00am ET / 1:00pm BST
LONDON, UK, April 1, 2019 — Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced that Claire Roddie MB, PhD, FRCPath, honorary senior lecturer, Cancer Institute, University College London (UCL), presented today initial data from the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult acute lymphoblastic B cell leukemia (ALL) as a late-breaking poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2019 in Atlanta, Georgia.
Relapsed / refractoryB-cell acute lymphoblastic leukemia (r/rB-ALL) in adults is an area of significant unmet clinical need. Notably, no CD19 CAR T cell therapeutic has been approved to date for adults with r/rB-ALL. The key challenges identified in clinical studies testing standard CD19 CART-cells therapies in this setting are considerable toxicity associated with severe cytokine release syndrome (CRS) and high-grade neurological toxicity.
AUTO1 uses a novel CD19 binder that allows the CAR T cells to disengage rapidly after target cell encounter and kill. Preliminary data from the ongoing Phase 1/2 CARPALL trial of AUTO1 in pediatric ALL presented at the 1st European CAR T Meeting organized by European Hematology Association (EHA) in February 2019 indicated that AUTO1 has a well-tolerated safety profile and did not induce high grade CRS in pediatric patients.
As of the data cutoff date of March 18, 2019 in the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult ALL patients, 13 patients were leukapheresed, and products for 12 patients were manufactured, including 7 with Autolus’ semi-automated, fully enclosed manufacturing process. Two patients are pending infusion. Among the 10 infused patients to date, the median age is 41 and 70% were male, with median lines of treatment of 4 (the range is2-7). Five of the ten treated patients had³ 50% BM blasts and were considered to be high-risk for severe CRS. Patients received a split dose based on disease burden for a total dose of up to 410 million cells.
Safety results
Using the Lee criteria, there were no patients with severe CRS (³ Grade 3), and 2 of 10 patients (20%) with Grade 2 CRS. Tocilizumab was used in 2 of 10 patients (20%). None of the patients were admitted to intensive care due to CRS. One patient developed delayed Grade 3 neurotoxicity following high levels of CAR T expansion, which was quickly reversed with steroids. Four patients died while enrolled in the trial, two due to progression of leukemia and two due to sepsis, a common complication of advanced ALL.
