SEATTLE--(BUSINESS WIRE)--The Alliance for Children’s Therapeutics (ACT), a pediatric research collaboration between Seattle Children’s Research Institute and biotech company Kineta Inc. whose goal is to speed development of new medications for children and teens with autoimmune diseases, today marked its first year anniversary with an encouraging status report on early research efforts using Kineta’s lead drug dalazatide, formerly ShK-186, for children and teens with lupus nephritis.
Lupus nephritis is an autoimmune disease which causes kidney inflammation and damage. The aim of this ACT research project is to find an alternative to the medications available today for children and teens with lupus nephritis. Current medications are effective in reducing some of the inflammation associated with the disease, but they also suppress the immune system, a side effect that is particularly undesirable in children.
“Research in lupus over the last few years has demonstrated that cells of the immune system, known as T cells, are an important player in orchestrating the autoimmune attack that occurs in lupus,” said Dr. Ernesto Muñoz of Kineta.
In particular, effector memory T cells have been associated with development of other autoimmune diseases such as psoriasis and rheumatoid arthritis and seem to play a predominant role in causing lupus nephritis. T cells secrete inflammatory mediators (cytokines) that cause tissue damage and inflammation. T cells and B cells make antibodies, which can amplify inflammatory responses.
These effector memory T cells depend on a potassium channel called Kv1.3 to function; dalazatide, a first-in-class peptide blocker specifically targets this channel.
“Over the past year, we have demonstrated that effector-memory T cells isolated from patients with lupus express higher levels of Kv1.3 than T cells from healthy controls,” said Dr. Anne Stevens, a principal investigator in the Center for Immunity and Immunotherapies at Seattle Children’s Research Institute, and an attending physician at Seattle Children's Hospital. “Moreover, patients with active flares of lupus nephritis seem to have higher levels of surface expression of Kv1.3 when compared to those patients with inactive disease. This could have important applications as a test for disease activity so that we can adjust medication intensity and identify patients who may respond to dalazatide.”
Preliminary data from the ACT collaboration also suggests that dalazatide is able to selectively block the ability of effector memory T cells to produce inflammatory cytokines implicated in disease. Ongoing ACT research seeks to expand these observations to a greater number of patient samples and test for the target of dalazatide in kidney biopsies. Future work will focus on measuring other parameters of T cell function and the evaluation of their immunomodulation by dalazatide, as well as analysis of Kv1.3 expression in the kidney cells of lupus patients. This work will serve as the foundation for the rationale to evaluate dalazatide in a proof of concept clinical trial for patients with lupus nephritis.
Bringing together one of the U.S.’s top five pediatric research institutions with a leading biotechnology company, ACT aims to speed development of medicines for children and teens with autoimmune diseases.
There are significant barriers in developing pediatric therapies and the lack of pediatric medication use information poses risks to children and teens. The shortage of appropriate formulations may deny access and expose them to medications that were not designed for their growing bodies. The challenge of recruiting sufficient numbers of pediatric patients for clinical research also delays the development of better therapies for pediatric diseases and conditions.
In 2014, the U.S. Food and Drug Administration (FDA) approved 41 new drugs; only 4 were approved for pediatric use. And of the 55,000 clinical trials conducted between 2005 and 2010, only nine percent were designed for children.
For more information, please visit the Alliance for Children’s Therapeutics Website at www.childrenstherapeutics.org.
About Kineta, Inc.
Kineta, Inc. is a Seattle-based privately held biotechnology company specializing in clinical advancement of novel drug candidates derived from leading edge scientific research. Our world-class scientists are pioneers in developing life-changing classes of new drugs designed to be more effective and safer than current medicines. Kineta seeks to improve the lives of millions of people suffering from autoimmune and viral diseases and from severe pain. Our progressive business model focuses on targeting unmet medical needs and rapid achievement of important clinical milestones. For more information on Kineta, Inc. visit our website, www.Kinetabio.com.
About Seattle Children’s Research Institute
Located in downtown Seattle’s biotech corridor, Seattle Children’s Research Institute is pushing the boundaries of medical research to find cures for pediatric diseases and improve outcomes for children all over the world. Internationally recognized investigators and staff at the research institute are advancing new discoveries in cancer, genetics, immunology, pathology, infectious disease, injury prevention and bioethics, among others. As part of Seattle Children’s Hospital, the research institute brings together leading minds in pediatric research to provide patients with the best care possible. Seattle Children’s serves as the primary teaching, clinical and research site for the Department of Pediatrics at the University of Washington School of Medicine, which consistently ranks as one of the best pediatric departments in the country. For more information, visit http://www.seattlechildrens.org/research.
Dalazatide (formerly ShK-186) has a novel mechanism of action (MOA). Preclinical and clinical data have shown that dalazatide is a selective and potent blocker of the voltage-gated Kv1.3 potassium channel - a key channel in the activation of effector-memory T cells. Effector memory T cells are implicated in the pathology of many autoimmune diseases. Dalazatide was the first specific Kv1.3 inhibitor advanced into human clinical trials. Dalazatide is being studied as a potential therapy for autoimmune diseases including lupus, ANCA Vasculitis, multiple sclerosis, psoriasis, psoriatic arthritis, rheumatoid arthritis, type 1 diabetes, inflammatory bowel diseases, asthma, atopic dermatitis and autoimmune eye diseases. The lupus, multiple sclerosis, and inflammatory bowel disease research is being conducted in conjunction with the Alliance for Children’s Therapeutics, a drug development and funding collaboration between Kineta and Seattle Children’s Research Institute.
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