Kymab, an emerging biopharmaceutical company focused on the discovery and development of fully human monoclonal antibody drugs, announce KY1005, its novel human antibody therapeutic, has successfully completed dosing of the 24th subject in its first clinical study
KY1005, a fully human monoclonal antibody, is a potential first-in-class therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions.
It binds to OX40L and blocks it from activating OX40, a protein inducing a prolonged response in T-cells, which can lead to diseases of the immune system and damaging effects on patients.
By blocking this activation, K1005 may act to bring the immune system back into balance. This could lead to a profound clinical impact and restoration of healthy organ functions in autoimmune conditions.
Autoimmune diseases affect up to 50 million Americans, according to the American Autoimmune Related Diseases Association (AARDA).
There are over 80 types of autoimmune disease, including graft-versus-host-disease (GvHD), rheumatoid arthritis, psoriasis, multiple sclerosis (MS), lupus and inflammatory bowel diseases (IBD), such as Crohn's disease and ulcerative colitis.
Current treatments for autoimmune diseases tend to suppress the immune system on a broad basis, leading to significant side effects. One of the potential advantages of KY1005 is it has the potential to be a more targeted treatment.
Dr David Chiswell, CEO of Kymab, said: "KY1005 is the first of a series of products we are developing focused on autoimmune diseases, immune-oncology, haematology and infectious disease. Our vision is to build Kymab into a major global biopharmaceutical company. This, the first of what will be a steady stream of clinical trials, is an important step towards realising our vision."
Indeed, the potential of KY1005 is such that, on its own, it could treat a number of immune and inflammatory disorders. We are confident that this will be the first of several trials on this antibody alone.
KY1005 has already shown outstanding pre clinical results in a project led by Dr Leslie Kean, Associate Director of the Ben Towne Center for Childhood Cancer Research at Seattle Children's Research Institute, published in a poster presentation at the American Society of Hematology Annual Meeting in San Diego in 2016. The experiments demonstrated that KY1005 anti-OX40L antibody has an important role in treating immune diseases.
The research showed that KY1005 dampened the exaggerated immune response that causes acute GvHD, a common and potentially deadly complication of bone marrow transplants.
Most strikingly, when combined with an established, yet on its own insufficient therapy to prevent acute GvHD, KY1005 completely prevented signs of acute GvHD. Dr Kean described the results "as unprecedented for a prophylactic approach to controlling disease following bone marrow transplant."
Professor Allan Bradley FRS, CTO and Co-Founder of Kymab, said: "Since our foundation only 7 years ago, we have generated a number of best-in-class drug candidates using our exquisite antibody platform, which we developed to contain the entire repertoire of human antibodies, making it the most comprehensive antibody development platform available.
"To now have our first antibody firmly on its clinical development pathway, with a rich pipeline of future products following, is a significant milestone and a testament to the unique qualities of the antibody drugs produced by our proprietary antibody platform as well as the performance of the Kymab team in progressing them rapidly through development and into the clinic."