Syncona updates on Autolus – Autolus Therapeutics, a key holding for Syncona, has announced additional data regarding its ongoing Phase 1/2 clinical trial of its next-generation programmed T cell therapy, AUTO3, to treat adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL). The data is to be presented in a keynote lecture titled “Improved CAR T cell approaches for lymphoid malignancies,” by Dr. Martin Pulé, clinical senior lecturer in the Dept. of Hematology at UCL Cancer Institute and chief scientific officer of Autolus Therapeutics, at the EHA-EBMT 2nd European CAR T Cell Meeting to be held on January 30, 2020 at 17:15 P.M. CET in Stiges (Barcelona), Spain.
“The incremental update in the AUTO3 trial presented at the 2nd European CAR T Cell Meeting continue to support the encouraging early indications of durability and high level of activity previously reported. Together with the encouraging signs of a manageable safety profile in adult patients with DLBCL, these early data for AUTO3 show the potential for a differentiated product profile,” said Dr. Christian Itin, chairman and chief executive officer of Autolus.
As of the data cut-off date of January 21, 2020 (data availability as of January 28, 2020), 18 patients in the ALEXANDER Phase 1/2 clinical trial of AUTO3 (see below) were evaluable for safety and efficacy.
In the cohorts dosed at 450 x 10(6) AUTO3 cells plus pembrolizumab, five out of seven patients achieved a response (complete response + partial response) and four out of seven patients achieved a complete response.
Across all dose levels, seven out of eight complete responders had ongoing complete responses at a median follow up of six months.
Seven out of seven complete responders treated with AUTO3 and pembrolizumab have ongoing complete responses as of January 21, 2020.
AUTO3 was generally well tolerated, with no patients experiencing dose limiting toxicity, and there were no treatment-related deaths. One patient experienced a Grade 4 lung infection due to para-influenza virus that was possibly considered to be related to treatment and the patient is recovering. Such infections are a common event in late stage DLBCL patients. No patients experiencing Grade 3 or higher Cytokine Release Syndrome (CRS) were reported with primary treatment (one patient experienced Grade 3 CRS on retreatment), and one of 18 patients experienced a Grade 3 neurotoxicity that resolved swiftly with administration of steroids. As of the data cut-off, no patient has experienced neurotoxicity of any grade in cohorts treated with AUTO3 and pembrolizumab.
Auto 3 is the first investigational CAR-T cell therapy containing two independent chimeric antigen receptors targeting (cancer markers) CD19 and CD22. By simultaneously targeting two antigens, AUTO3 is designed to minimize relapse due to single antigen loss in patients with B cell malignancies. AUTO3 is currently being tested in adult diffuse large B cell lymphoma in the ALEXANDER clinical trial and in pediatric ALL in the AMELIA clinical trial.
SYNC : Syncona updates on Autolus