Spinout News
UCL spinout Autolus Therapeutics has received marketing authorisation from the European Commission for its next-generation CAR T-cell therapy to treat adults with an aggressive blood cancer
23 July 2025
The personalised therapy, named Obecabtagene autoleucel (obe-cel) and marketed as AUCATZYL®, is for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (‘ALL’).
This latest authorisation means Aucatzyl will now be available in all 27 European Union Member States, Iceland, Norway and Liechtenstein. It follows similar approvals from the UK’s Medicines and Healthcare products Regulatory Agency the U.S. Food and Drug Administration (FDA).
Autolus Therapeutics was founded by Dr Martin Pule who leads the UCL CAR-T cell programme, which is supported by the National Institute for Health and Care Research UCLH Biomedical Research Centre (BRC).
The company was established with the support of UCL Business (UCLB), UCL’s commercialisation company.
UCLB worked with the Autolus team from the start, helping protect the IP for the CAR-T obe-cel technology and attracting investment to enable the business to take AUCATZYL® through clinical trials. It has raised over $1bn and invested significantly in the UK, including building a state-of-the-art manufacturing facility, The Nucleus in Stevenage, employing 450 people.
“The close relationship between Autolus and UCLB has spanned more than a decade since UCLB helped establish the company in 2014. I’m delighted about the approval of AUCATZYL in the EU, which represents a huge milestone in Autolus’ success story. It also underscores the important role of long-term capital investment and other support in helping university spinouts bring advanced therapeutics from the research lab to the market where they can benefit patients.”
Around 8,400 new cases of ALL are diagnosed every year in the US and EU. Of these, over 3,000 will either relapse or not respond to standard treatment. For adult patients with r/r ALL, prognosis is poor with a median overall survival of eight months.
The EC approval was based on the results of the FELIX study, an open-label, multi centre, single arm study in adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia. The results were published in the New England Journal of Medicine in November 2024. In the pivotal cohort of patients, (cohort IIA (n=94)), the Complete Response/Complete Response with Incomplete Haematological Recovery (CR/CRi) for patients who received at least one infusion of obecabtagene autoleucel was 76.6%. Median response duration for all infused patients was 21.2 months. Median event-free survival (EFS) was 11.9 months and the estimated 6- and 12-month event-free survival rates were 65.4% and 49.5%, respectively.
What is CAR T-cell therapy?
CAR T-cell therapy involves collecting a patient’s own white blood cells (T-cells, responsible for fighting infection), ‘reprogramming’ them in the laboratory to seek and ‘fight’ the cancer cells and giving them back to the patient via infusion.
Patients’ T-cells are genetically programmed to make an artificial protein called a CD19 chimeric antigen receptor (CAR) on their surface, directing them to specifically recognise cancerous cells.
Development of obe-cel/AUCATZYL®
Aucatzyl modifies T-cells to produce a new type of CAR called obecabtagene autoleucel or obe-cel, which overcomes two common constraints associated with ‘first generation’ CAR T-cell therapies. One was that the immune system became over-activated, causing a toxic reaction and the other problem was that T-cells became exhausted and were not able to persist in a patient’s body.
Obe-cel was designed by scientists from UCL Cancer Institute, along with collaborators at the UCL Great Ormond Institute of Child Health and UCLH.
AUCATZYL will be manufactured at Autolus’ commercial manufacturing site in Stevenage, which will supply the therapy globally. The manufacture of obe-cel was developed at the Centre for Cell, Gene & Tissue Therapeutics, Royal Free Hospital. Clinical development in adult B-ALL was built on the ALLCAR19 clinical study, led by UCL and UCLH, and supported by grant funding from the NIHR.
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Image credit: Autolus Therapeutics