Autolus Therapeutics announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia

UCL spinout, Autolus Therapeutics, an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for AUCATZYL® (obecabtagene autoleucel, obe-cel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

The foundational research underpinning obe-cel was conducted at UCL and led by Martin Pule and his collaborators at the Cancer Institute and Great Ormond Street Institute of Child Health.  In 2018, UCLB and Autolus entered into a licence agreement for patent rights relating to obe-cel.

Additionally, UCL, through its Cancer Trials Centre, have a long term strategic collaboration with Autolus and have conducted obe-cel clinical studies in pediatric and adult patients with r/r B-ALL and in patients with r/r B-cell Non-Hodgkin’s Lymphoma.

Obe-cel was approved by the FDA based on results from the Autolus FELIX clinical trial in adult patients with r/r B-ALL. Marketing authorisation applications (MAAs) for obe-cel in adult r/r ALL are being reviewed by the regulators in both the EU and the UK.

UCL Business (UCLB) has supported Autolus in protecting and licensing the obe-cel technology enabling it to attract further capital for to fund its development. “This news is a great example of industry and academic collaboration delivering real impact,” said Dr Rick Fagan, Director of BioPharm, UCL Business (UCLB). “It has been exciting to support Autolus and see its paradigm-shifting advanced therapeutic reach this hugely important stage.”

“This is a tremendous milestone for Autolus,” said Dr. Chris Williams, Chief Business Officer of Autolus. “We are grateful for the foundational work of our partners at UCL and our strategic collaboration that helped make this happen.”

For further information:

Read the announcement from Autolus Therapeutics.

About Autolus Therapeutics plc

Autolus is a biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has an FDA approved product, AUCATZYL, and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com

About UCL Business

UCLB is part of UCL, one of the world’s leading universities. We make sure the exceptional ideas and innovations generated by researchers at UCL and its associated hospitals – University College London Hospitals, Moorfields Eye Hospital, Great Ormond Street Hospital for Children and the Royal Free London Hospital – have real world impact, creating benefits for society and bringing revenue back to the university. UCLB’s track record of success includes over £2.85 billion raised in investment for UCL spinouts, bringing pioneering technologies from the laboratory to market. For more information visit www.uclb.com

Photo © Autolus