Dive Brief:
- Autolus Ltd. on April 4 announced a supply deal with the German Miltenyi Biotech GmbH, securing use of Miltenyi's automated cell-processing platform to manufacture its investigational T-cell therapies. The agreement also covers single-use equipment like reagents and disposables.
- Miltenyi's automated cell processing device, dubbed CliniMACS Prodigy, works via a magnetic field and helps engineers isolate specific T cells of interest. This type of separation could be a crucial puzzle piece in the development of more effective cancer immunotherapies, as younger phenotypes of T cells are thought to perform better.
- In addition, automation of cell processing steps could potentially lead to more sterile final products due to less frequent manual handling of the cells during production.
Dive Insight:
Miltenyi's Prodigy technology received a vote of confidence from the European Medicines Agency two years ago, when the regulatory body approved the use of device for the GMP manufacture of MolMed SpA's Zalmoxis, a T-cell based supportive therapy for leukemia. This regulatory OK marked the first time the device was to be used in a manufacturing process for a commercial drug.
Perhaps also reassuring to Autolus is the fact that Miltenyi has teamed up with big pharma in the past. In March 2016, GlaxoSmithKline plc partnered with Miltenyi on a collaboration to develop cell and gene therapies — and GSK outlined in a 2017 company presentation how use of Prodigy could help automate many of the upstream bioprocessing steps for development of T cell therapies.
GSK's enthusiasm for cell therapy, however, may have waned in the wake of a pipeline revamp led by CEO Emma Walmsley.
Miltenyi would not disclose whether it will receive a financial cut of Autolus' CARs made on the Prodigy platform should the products ever reach commercial markets.
For its part, Autolus develops novel CAR-T constructs that target two antigens. One of its assets targets both CD19 and CD22 (in the ALEXANDER trial for diffuse large B-cell lymphoma and the AMELIA trial for pediatric acute lymphoblastic leukemia) and another is directed to BCMA and TACI (in the APRIL trial for multiple myeloma).
The CARs Autolus is developing have an on/off safety switch — otherwise known as a pharmacological control switch — that theoretically turns CAR-T cell activity off unless in the presence of two specific antigens. The dual targeting is believed to allow a more controlled killing of antigens, and the dual-engineered T cells are thought to be associated with enhanced T-cell persistence, which could lead to better anti-tumor activity.
The company was founded in July 2014 as a spin-off from the University of College London and last fall secured $80 million in Series C Funding backed by several investors.
The executives at Autolus are well-versed in dual targeting. Prior to the formation of Autolus, Christian Itin, Autolus' CEO, was president and CEO of Micromet Inc., a company that was acquired in March 2012 by Amgen, Inc. for $1.2 billion. Micromet led the development of bispecific T-cell engagers (BiTEs) — also known as bispecific monoclonal antibodies — and laid the groundwork for the eventual approval by the Food and Drug Administration of Blincyto (blinatumomab), Amgen's first-in-class biologic.