Europe takes cancer science into ­immunology

Getting cancer immunotherapies approved and marketed took vast amounts of clinical trial research, which led to advancements in our knowledge of the immune system, how it works and how to manage it. Over the past few years, landmark research from European scientists has shown that CAR-T therapy – an immunotherapy first developed and approved in oncology – can induce remission in some patients with severe lupus.

The idea behind the research came from scientists such as Georg Schett and professor Ricardo Grieshaber-Bouyer, from the Uniklinikum Erlangen at Friedrich-Alexander-Universität Erlangen-Nürnberg. Scientists at University College London Hospital (UCLH) led by Claire Roddie and Maria Leandro have also been trialling the technology in humans to treat lupus.

The idea hinges around the way that CAR-T cells can be reprogrammed to attack the B-cells that are the root cause of lupus, where the immune system begins to attack the patient’s own body. Symptoms of the disease include joint pain, skin conditions and damage to organs such as the kidneys. Harvested from a patient’s own body, genetically modified, expanded and then reintroduced through infusion, the CAR-T cells reset the immune system by destroying all B cells in the body, both healthy and disease-causing. Once the treatment is over, the healthy B cells grow back, and the patient’s immune system is reset, without the symptoms of lupus.

The drawbacks: the therapy is expensive and takes a long time to make as it is tailored to each individual patient. Side effects in the Phase 1 CARLYSLE trial at UCLH were more manageable, however. Researchers observed no cases of immune effector cell-associated neurotoxicity syndrome (ICANS), a serious neurological side effect associated with some CAR-T cell therapies. Cytokine release syndrome (CRS), another common side effect of CAR-T therapy where the immune system becomes overstimulated, was limited to only low levels.

As of November 2025, nine adults with severe, treatment-resistant lupus had received the treatment, obecabtagene autoleucel, developed by London-based Autolus. All had highly active disease despite multiple previous therapies, and most had lupus nephritis, a serious form of the disease that affects the kidneys. Researchers found that five of the first six patients treated at the lower dose achieved remission according to standard lupus criteria, with improvements emerging within months of treatment. Patients also experienced rapid reductions in disease activity. For patients whose kidneys had been affected by the disease, several achieved complete or partial renal responses, with reductions in proteinuria and stabilization or improvement in kidney function over time.

It’s just one example of how expertise in cancer has begun to inform the treatment of autoimmune diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease and ulcerative colitis. Iain Kilty, CEO of UK-based biotech Sitryx, described results from CAR-T therapy in lupus as “phenomenal.” “We are seeing sustained remission as it kills the cells that are driving the disease,” he added.

However, Kilty noted that the same drawbacks that applied to CAR-T in cancer apply in immunology. While early autoimmune studies have suggested that some familiar CAR-T toxicities may be manageable, safety remains a major question, alongside a manufacturing process that is still cost- and labor-intensive. That question gained new urgency in August, when Novartis paused eight studies of its CD19 CAR-T rapcabtagene autoleucel in autoimmune and neurological diseases after three patients died from immune effector cell-associated hemophagocytic syndrome (IEC-HS), a severe inflammatory complication. The company is reviewing the cases with regulators and independent safety boards.

Pawel Szczepanski, CEO of Poland’s JJP Biologics, added: “Looking at a purely scientific perspective, the boundary from oncology and autoimmunology is increasingly porous. In cancer, immune response may be insufficient, exhausted and depressed. In autoimmune disease, responses may be persistent and misdirected toward healthy tissue. This creates a degree of target or platform symmetry – a pathway strengthened in oncology may be inhibited in immune disease.”

Technology and platforms can be transferred from oncology to autoimmune diseases, along with the knowledge and technical know-how required to discover, manufacture drugs and bring them to market. Szczepanski added: “Expertise in antibody, T-cell therapy, biomarkers and immune monitoring can be transferred. Oncology tech cannot be transferred unchanged, but the synergies exist there. I would dare to say the synergies between target platforms and portfolios are quite evident. We see examples of going from oncology into inflammation and immunology and there is also a portfolio rationale. It creates opportunities to reuse platforms in multi-indication markets.”

A growing demand

Driving the research is the demand for new drugs in autoimmune diseases and inflammation. The first generation of blockbuster autoimmune disease drugs, such as AbbVie’s Humira (adalimumab), is encountering biosimilar competition; and while they redefined treatment of many diseases, they were not perfect. They superseded medicines such as methotrexate, which are effective but come with a long list of side effects. Even with biologic therapies, remission only occurred in a fraction of patients depending on the disease area, with considerable unmet need.

Between 10% and 30% of patients fail to respond to treatment with anti-TNFs such as Humira, Kilty noted, adding that patients are also looking for convenience with either less frequent injections or medicines administered in pill form.

Inflammation and immunology continue to tick the right boxes for big pharma investment in research, according to JJP Bio’s Szczepanski. He said: “Immunology as an area has a few characteristics that large pharma tend to appreciate, the substantial disease burden, treatment demand, specialist care infrastructure and the possibility to apply one mechanism across multiple indications. Those are the characteristics that make it attractive to big pharma.”

JJP Biologics is part of a biotech ecosystem that is becoming established in Poland. The company’s most advanced clinical asset is nebaprubart, a CD89 inhibitor that is in Phase 1b development in autoimmune diseases. Research has been slowed in this receptor because it is not expressed in mice, meaning that the drug had to be proven in several different preclinical models before it was cleared for human trials. The company’s focus is not only on IgA-driven renal conditions but also on the “big four” inflammation areas: rheumatoid arthritis, inflammatory bowel disease, psoriasis and systemic lupus. Szczepanski said: “We clearly see that despite the general perception that those are crowded markets, the deeper you look, the more you challenge that perception.”

Kilty’s work at Sitryx was informed by research originally done by professor Luke O’Neill of Trinity College, Dublin, which suggested PKM2 serves as a critical metabolic switch not only in cancer, but also in chronic inflammation. In the case of diseases such as atopic dermatitis, Sitryx aims to modulate the pathway to normalize the activity of the immune system. The company’s lead drug SYX-5219 is heading for Phase 2 in atopic dermatitis, with an itaconate mimetic SYX-1042 also ready for Phase 2 in psoriasis and psoriatic arthritis.

Both Kilty and Szczepanski agree that there is a promising decade for European research into inflammatory and autoimmune diseases, driven by demand for new products and a supply of R&D know-how in academic institutions and the biotech sector. Kilty concluded: “It’s important to focus on those areas where we are differentiated. There’s lots of competition in America and China, and the speed at which they can develop drugs. We have that expertise in Europe, we have people who have progressed assets from idea to approval.”