A variety of therapeutic antibodies and cell-based therapies have been developed for the treatment of autoimmune diseases. But the evaluation of therapeutic efficiency and safety for these new autoimmune disease therapies is quite different from that of small molecules. Therefore, Creative Biolabs has successfully integrated an innovative technology platform to provide tailor-made therapeutic outcome evaluation services for novel autoimmune disease therapy.
The human immune system defends the body from disease and pathogenic microorganism infection through complex immune reactions. Autoimmune disease occurs when the immune system reacts or attacks against its own healthy cells and tissues. Currently, autoimmune disease has emerged as one of the prevalent human diseases all over the world with high morbidity and mortality. Conventionally established therapies for autoimmune diseases mainly relied on anti-inflammatory drugs to control symptoms, non-specific immunosuppressants to inhibit immune responses, and other chemotherapeutic agents. However, autoimmune disease is a chronic disease involving multiple organs. To better control disease, high doses, long-term, and multiple drug combination treatments are often needed, which brings serious toxicity, side effects, and increased susceptibility to infections and tumors.
Therefore, specific strategies and novel effective therapy development for autoimmune disease treatment have been widely explored to reduce the risk of systemic immune suppression, decrease the toxicity and side effects, while improving immune tolerability of the host. These effective novel agents or therapies mainly include:
Fig.1 Examples of combination therapy for autoimmune disease. (Smilek, 2014)
New therapies, including therapeutic antibodies, T cell therapy, and stem cell-based therapy, all bring opportunities and hope to the treatment of autoimmune diseases. More than 10 therapeutic monoclonal antibodies have been approved by the Food and Drug Administration (FDA), and hundreds of clinical trials using stem cell therapy are in progress to treat various autoimmune diseases. However, since the standards and methods for pharmacology and safety evaluation designed for conventional drugs are not so applicable to antibody and cell-based therapies, it is necessary to find new methods to evaluate the therapeutic outcomes and safety for autoimmune diseases.
To comprehensively evaluate the efficacy and safety of autoimmune disease new therapies, both preclinical and clinical trials are needed. Evaluations in vitro, in autoimmune disease animal models, and in normal animals, all should be performed to exclude anti-disease properties and find out the most effective and safest dose for human clinical trials. In every preclinical assessment, autoantibodies levels, autoreactivity, immunocytes components, degree of tissue recovery, biochemical index, and so forth all should take into account.
To treating autoimmune diseases effectively, a full range of new immunotherapies, including therapeutic monoclonal antibodies, bispecific antibodies, regulatory T cell therapies, and cell-based therapies (such as stem cell-based therapy) have been extensively explored and developed. Creative Biolabs, which is always devoted to novel therapy discovery for human health improvement, provides highly qualified and highly tailored services for autoimmune disease therapy development.
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Creative Biolabs is a world-leading CRO that is skilled in developing novel therapies,
especially in antibody and cell therapy for autoimmune diseases.
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