TxCell and Ospedale San Raffaele have partnered up to research a new treatment for Lupus, based on engineered regulatory T-cells (CAR-Treg). 

txcell_ospedale_san_raffaele_carTxCell is developing immunotherapies based on the discovery of a type of T-cells that have anti-inflammatory properties – regulatory T lymphocytes (Tregs).

Tregs have already yielded two candidates. Osave is currently on phase IIb trial for refractory Crohn’s disease, and Col-Treg has received Orphan Drug Designation to treat autoimmune uveitis, which causes blindness.

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TxCell is now moving to its second technology platform with ENTrIA, which stands for ‘Engineered Treg for Inflammation and Autoimmunity‘. It creates engineered Tregs with chimeric antigen receptors (CAR) – the same strategy that yields CAR-T therapies for cancer.

regulatory_t_cell_mechanism_txcell_autoimmune

Fig 1: Mechanisms of regulatory T-cells to module immune response.

The first CAR-Tregs will be developed for lupus nephritis, one of the most serious complications which affects the kidneys in lupus erythmatosus – a rare autoimmune disease with high unmet medical needs.

TxCell succeeded in engineering a type of regulatory T-cell (FoxP3+ Treg), which now integrates the binding domain of a pathogenic antibody from patients suffering from lupus nephritis.

In order to advance development, TxCell will be collaborating with Ospedale San Raffaele (OSR) in Milan – one of the largest hospitals in Italy. It is also a prestigious research institution for cell and gene therapy, and is involved in projects like CARAT for CAR-T manufacturing.

The collaboration will focus on the pre-clinical development, including pharmacology and toxicology studies – in preparation for first-in-man trials.

car-treg_txcell_lupus_nephritis_autoimmune

Fig 2: Workflow of CAR-T therapies.

Besides the application in lupus, TxCell and OSR will study the biology of CAR-Treg and possible designs, that could be used to treat other autoimmune indications.

It is estimated that around 5 million people have Lupus, with 60% likely to develop kidney complications (nephritis). And autoimmune indications are also a highly desired market.

So, this new platform for biologics against autoimmune diseases is very interesting – especially if it should have the same efficacy as CAR-T for cancer.


Figure 1 credit: Jacobson and Ritz (2011) Time to put the CAR-T before the horse. Blood (doi: 10.1182/blood-2011-09-376137) [adapted]
Figure 2 credit: Vignali et al. (2008) How regulatory T-cells work. Nature Reviews Immunology (doi: 10.1038/nri2343)
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