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T-Cell Therapy Trial Begins for Autoimmune Diseases

Nektar Therapeutics lab

Nektar Therapeutics lab in San Francisco (Nektar Therapeutics)

27 March 2017. A biotechnology company began testing on humans an experimental drug to increase healthy T-cells in the immune system for people with autoimmune disorders. The early-stage study is testing the safety, dosage levels, and chemical activity in the body of a biologic drug code-named NKTR-358 by its developer, Nektar Therapeutics, in San Francisco.

Autoimmune diseases are disorders that arise from an erroneous immune response aimed at healthy cells and tissues in the body, instead of invading pathogens from outside. Examples of autoimmune disorders are type 1 diabetes, rheumatoid arthritis, lupus, psoriasis, Crohn’s disease, and multiple sclerosis. American Autoimmune Related Diseases Association cites data from National Institutes of Health estimating 23.5 million people in the U.S. suffer from autoimmune diseases, but the organization believes the actual number may be more than twice as high.

According to Nektar, most current treatments for autoimmune disorders are designed to suppress the immune system overall, which can have serious undesired side effects. The company instead is developing NKTR-358 to balance the overabundance of effector T-cells, white blood cells in the immune system, programmed to immediately react to perceived invaders, with more regulatory T-cells to help control over-reactions to immune-system threats.

Nektar develops treatments that combine polymer chemistry with active biological agents to control their targeting, distribution, and activity in the body, in what the company calls polymer drug conjugates. NKTR-358 aims to promote production of regulatory T-cells to correct the imbalance with auto-reactive effector T-cells, and restore the body’s self-tolerance mechanisms in people with autoimmune diseases. The company says its preclinical studies show NKTR-358 can suppress skin inflammation caused by immune-system reactions, and reduce indicators of lupus progression in lab mice.

The company is designing NKTR-358 as a self-administered injection given once or twice a month. The clinical trial is recruiting 50 healthy individuals to test the safety of NKTR-358 and its chemical activity in the body. The trial is also testing various dosage levels, with the goal of determining safe doses for future studies of NKTR-358 among people with autoimmune diseases.

The first trial of NKTR-358 in people with autoimmune diseases is expected to take place in the second half of 2017, a study of the drug among individuals with systemic lupus erythematosus, the full name for lupus. In this case, the autoimmune disease leads to inflammation in the joints, skin, and other organs including heart, lungs, and kidneys. Lupus is more common in women than men, mainly affecting people between the ages of 10 and 50.

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