On September 18, 2017 UCL Business spinout company, Autolus Limited, a clinical-stage biopharmaceutical company focused on the development and commercialisation of next-generation engineered T-cell therapies, reported initiation of both the AMELIA and ALEXANDER phase I/II studies of its novel, dual-targeting, AUTO3 Chimeric Antigen Receptor (CAR) T-cell therapy (Press release, UCLB, SEP 18, 2017, View Source [SID1234520559]).
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AUTO3 is an autologous T-cell product, genetically modified to express two separate CARs which recognise CD19 and CD22; two antigens expressed by cancer cells in B-cell leukaemia and lymphoma. AUTO3 is designed to minimise the risk of relapse due to antigen loss, a key mechanism of resistance shown in single antigen targeting CAR-T therapies.
The AMELIA and ALEXANDER Studies are dose-escalation phase I/II studies in paediatric Acute Lymphocytic Leukaemia (ALL) and adult Diffuse Large B-Cell Lymphoma (DLBCL) in which cohorts of patients receive ascending doses of AUTO3 to determine the maximum tolerated dose and establish a recommended dose. The second part of the study is an expansion phase where patients receive AUTO3 to further evaluate the safety, tolerability and clinical activity at this recommended dose. In addition to the effects of AUTO3 alone, combination with short-duration use of a checkpoint inhibitor is also being evaluated in the ALEXANDER study.
Dr Martin Pule, Autolus’ Founder and Chief Scientific Officer said:
"Our approach at Autolus is to understand how tumours defend against T-cells and then design and programme CAR-T cell products which specifically address those defence and escape mechanisms. The AUTO3 programme seeks to overcome two limitations of current therapies by introducing dual targeting CARs and addressing checkpoint mediated inhibition."
Professor Persis Amrolia, Professor of Transplantation Immunology, Great Ormond Street Hospital, London commented:
"The advent of CD19 CAR-T cell based therapy is an exciting and revolutionary advancement in the treatment of children with relapsed ALL. However, in approximately a third of the patients the disease reoccurs by losing CD19 antigen. AUTO3, a dual targeting CAR, addresses this challenge by independently targeting CD19 and CD22 antigen, which has the promise of reducing antigen escape."
Dr Anas Younes, Chief, Lymphoma Service at Memorial Sloan Kettering Cancer Center, New York commented:
"CD19-directed CAR-T cell therapies already offer the possibility of an important new treatment option for patients with relapsed and refractory DLBCL. AUTO3 is a novel approach which simultaneously targets a second clinically relevant antigen, CD22. The field is looking forward to seeing how patients respond to AUTO3 in clinical trials and whether dual antigen targeting CAR-T cell therapy offers the possibility of deeper initial and more sustained responses."