In recent years,CAR-TCell therapy has achieved tremendous success in the field of tumor treatment and has become a powerful weapon against various malignant tumors. There are as many as six in China alone.CAR-TThe product has been approved for market launch. Moreover, beyond oncology, an increasing number of studies are demonstrating thatCAR-TCell therapy has also shown potential in the field of autoimmune diseases. CAR-TWhat is the application prospect of cell therapy in the field of autoimmune diseases? What challenges and opportunities may this field face in the future?CAR-TWhat are the therapeutic effects or functional mechanisms of cell therapy in autoimmune diseases? How is it evaluated?CAR-TMarket scale and growth potential of therapies in this area? Currently at home and abroadCAR-TWhat are the important advancements in the research and development of cell therapy for autoimmune diseases? Which pipelines are worth paying attention to?
Frost & SullivanFrost & Sullivan,Zhao Yidi, consulting manager of the Life Sciences Business Unit at Frost & Sullivan in Greater China, was interviewed by China Business News to discussCAR-TThe application prospects of cell therapy in the field of autoimmune diseases.
Daily Economic News
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Q: Approved domestically6modelCAR-TProducts, but their indications are all for tumors. TargetingCAR-TWhat are the prospects for cell therapy in the field of autoimmune diseases, and what are the views and expectations? What challenges and opportunities may this area face in the future?
CAR-TThe successful application of cell therapy has opened up new avenues for treating autoimmune diseases, especially in the context ofBIn cell-mediated autoimmune diseases, such as systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, etc., it is mediated by a profound depletionBCells, including autoreactive onesBCell cloning may restore normal immune function, achieving what is known as 'immune reset'. For recipientsCAR-TFollow-up of patients with severe refractory systemic lupus erythematosus treated with cell therapy showed that patients had aCAR-TCell infusion has good tolerance, without producing serious toxic effects.CAR-TCell therapy brings cells into the patient's bodyBCells are rapidly cleared, accompanied by a decrease in peripheral bloodCAR-TRapid cell expansion. Patients receive drug injections.3After18There are no signs of disease recurrence within the past month.
althoughCAR-TCell therapy has begun to show results in the exploration of autoimmune diseases due to its unique targeted mechanism and significant efficacy. However, in reality, research and application in this field still face many urgent challenges that need to be addressed. The most challenging issues include the potential risk of secondary malignant tumors that may occur after treatment, which undoubtedly poses a new health threat to patients;BInsufficient specificity of cell clearance may lead to disease recurrence or drug resistance; the treatment process is relatively cumbersome, increasing the difficulty and complexity of actual operation; and the high cost of treatment constitutes an unbearable economic burden for most patients, thereby triggering payment difficulties and limitingCAR-TThe widespread application of therapies.
In the face of these challenges, biotechnology companies around the world are actively engaging in the development of innovative solutions with unprecedented enthusiasm and determination. They are committed to optimizingCARDesign, improve treatment specificity, simplify operational processes, develop new pretreatment strategies, and explore production processes with higher cost-effectiveness, all aiming to fundamentally solve current problems and promoteCAR-TThe in-depth development of therapies in the field of autoimmune disease treatment.
Q: Compared with traditional treatment methods,CAR-TWhat are the therapeutic effects or functional mechanisms of cell therapy in autoimmune diseases?
Common treatment methods for autoimmune diseases include glucocorticoids, immunosuppressants, and monoclonal antibodies.
Despite the widespread use of glucocorticoids and immunosuppressants, they have significant drawbacks. Their broad immunosuppressive effects can lead to impaired immune systems, making patients more susceptible to infections and other complications.
In contrast,mAbA targeted treatment method has been provided, which has relatively good therapeutic effects. However, some patients aremAbThe response was not satisfactory, requiring repeated dosing. This not only affects the patient's compliance and cooperation but may also lead to patient dissatisfaction with the therapeuticmAbThe immune response thereby weakens its effectiveness over time.
CAR-TThe therapy utilizes antigen specificityTThe precision of cell receptors holds the promise of completely transforming the treatment landscape for autoimmune diseases. It aims to selectively target and eliminate autoreactive immune cells while preserving overall immune function, thereby minimizing the risk of opportunistic infections and other adverse reactions caused by widespread immunosuppression. In addition, customizationCAR-TThe ability of cells to target specific autoimmune antigens holds promise for achieving more durable therapeutic effects and reducing the dependence on repeated dosing, ultimately improving the treatment outcomes and quality of life for patients.
Q: Given the prevalence and treatment needs of autoimmune diseases, how do you evaluateCAR-TWhat is the market size and growth potential of therapies in this field?
Although for nowCAR-TCell therapy is still in its early stages in this field, but it has already demonstrated certain efficacy and safety, laying a solid foundation for the subsequent approval of products.CAR-TThe potential application prospects of therapies in the field of autoimmune diseases are broad. On one hand, with the continuous maturation of technology and the continuous improvement of efficacy,CAR-TTherapies are expected to make breakthroughs in treating more types of autoimmune diseases; on the other hand, with the continuous improvement of the healthcare system and the innovation of payment pathways,CAR-TThe accessibility and affordability of therapies will be further enhanced, thereforeCAR-TCell therapy has tremendous growth potential.
Q: Currently, at home and abroadCAR-TWhat are the important advancements in the research and development of cell therapy for autoimmune diseases? Which pipelines are worth paying attention to?
Overseas:
Miltenyi BiomedicineThe company has developedCAR-T MB-CART 19.1Clinical trials have also been conducted for systemic lupus erythematosus. According to follow-up results over about six months, allSLEAll patients have achieved remission and discontinued immunosuppression. In terms of safety, no grade 3 cytokine release syndrome, immune cell-associated neurotoxicity syndrome, or bone marrow suppression was observed.
CabalettDeveloped by the companyCABA-201 CAR-TClinical trials of cell therapy for autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, and generalized myasthenia gravis are currently in clinical progress.I/IIperiod. The first batch of subjects in each trialCABA-201Patients in the treatment arm completed28No cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome of any grade was observed after the dose-limiting toxicity observation window for the day.
Domestic:
Domestic enterprises' own immunityCAR-TIn research and development, we are also at the forefront of the world. Currently, our country is conducting research and development on treatments for autoimmune diseases.CAR-TThere are already more than a dozen products in the pipeline, some of which have entered the registration clinical phase, while others are still in clinical research initiated by researchers.
The first original research product of Heyuan BiologyCAR-TCell therapy product, SinoCure Diagnostics®The clinical trial application for a new drug with an additional indication in the field of autoimmune diseases for (Nakijilansai Injection) has recently been approvedCDEImplied consent is used for the treatment of refractory systemic lupus erythematosus-associated immune thrombocytopenia.
Benorubicin developed by WuXi AppTec®(Retigliflozin injection) in2023year4Monthly receiptCDEThe clinical trial for tacrolimus implicit license, used for the treatment of moderate to severe refractory systemic lupus erythematosus, is currently in clinical development.I/IIperiod.
*This interview has been published in Daily Economic News The reporter is Xu Libo, and the original title is: CAR-TCell therapy expands to autoimmune diseases: Is it good news for patients with lupus erythematosus? >>
