Lupus is a chronic autoimmune disorder characterised by the body’s self-directed immune response causing pain and inflammation across a variety of vital organs such as the kidneys and lungs.

Lupus can be classified into several subtypes, with the predominant form being systemic lupus erythematosus (SLE).

SLE is characterised by its systemic impact on multiple organs and the potential for a diverse array of symptoms, rendering diagnosis challenging as the precise etiological factors initiating the disease process remain elusive.

Therefore, as there is not yet a definitive cure for the disease, currently available treatments focus on symptom management and modulation of the immune response associated with the condition.

Currently, specific drugs marketed for the treatment of lupus include GSK’s Benlysta, which was approved by the US Food and Drug Administration (FDA) in December 2011 for SLE and lupus nephritis (LN); Aurinia Pharmaceuticals’ Lupkynis, which was approved by the FDA in January 2021 for LN; and AstraZeneca’s Saphnelo, which was approved by the FDA in August 2021 for SLE.

However, in November 2022, data from a 2022 study published in Nature Medicine by German researchers found that chimeric antigen receptor (CAR) T-cell therapy could be promising in treating autoimmune diseases, including SLE.

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As this information spread across the industry, several drugmakers have revealed plans to develop cell therapies for lupus.

According to leading data and analytics company GlobalData’s Drugs Database, between January 2023 and March 2024, there were 18 CAR-T cell therapies in various stages of development (discovery to Phase III) for SLE/LN globally.

Despite the initial excitement about these therapies, some pharmaceutical companies have started to re-evaluate the development of CAR T-cell therapies in lupus.

One such company is Galapagos, which announced in February 2024 that it would be terminating its lupus CAR-T programme in refractory SLE and confirmed several layoffs for ‘strategic reasons’.

Although the exact reasons for this shift remain unclear, Galapagos’ decision to reevaluate its business development may be related to an announcement from January 2024, where the company disclosed a $27m deal to partner with BridGene Biosciences’ chemoproteomics platform for the discovery of new small molecules for cancer.

This decision might have been necessary for Galapagos as the company works to rebuild its pipeline and maximise its return on investment.

According to GlobalData, as of February 2024, the global cell and gene therapy (CGT) market value is anticipated to experience significant growth, with sales expected to increase from $5.6bn in 2023 to $66.0bn in 2029 at a compound annual growth rate of 50.8% (Figure 1).

Oncology is the leading therapy area of CGT development compared to immunology and musculoskeletal disorders, which include autoimmune disorders such as SLE.

An unmet need remains for the treatment of patients with SLE, particularly for refractory patients, as a treatment for this specific patient subgroup may help improve their quality of life, as well as be a potential cure.

However, obstacles persist in this space such as ongoing efforts to determine the cost-effectiveness of CGTs due to their high production costs.

Continued research and discussions in this space are necessary to reveal novel applications for therapies and enhance current methodologies, thereby broadening the therapeutic possibilities for patients.