• The third dosing cohort has been completed and 24 patients have now been dosed.
• KY1005-CT01 clinical study is targeting a total enrollment of 88.
• Primary completion is expected in 1H 2018.
• The study is a single and multiple ascending dose, placebo-controlled, double-blind, Phase 1 study to evaluate the safety and tolerability of KY1005 in healthy volunteers and patients with a mild-to-moderate immune system disease (psoriasis).
• KY1005 is an antagonist of OX40-Ligand (OX40L) with the potential to treat a number of immune and inflammatory disorders (autoimmune diseases).
Cambridge, UK, 31 July 2017 - Kymab, an emerging biopharmaceutical company focused on the discovery and development of fully human monoclonal antibody drugs, announces today that KY1005, its novel human antibody therapeutic, has successfully completed dosing of the 24th subject in its first clinical study.
“KY1005 is the first of a series of products we are developing focused on autoimmune diseases, immune-oncology, haematology and infectious disease,” said Dr David Chiswell, CEO of Kymab. “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.”
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.
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 that induces a prolonged response in T-cells of the immune system, 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. Current treatments for these diseases tend to suppress the immune system on a broad basis, leading to significant side effects. One of the potential advantages of KY1005 is that it has the potential to be a more targeted treatment.
“I am delighted that we have reached another important milestone for Kymab,” added Professor Allan Bradley FRS, CTO and co-founder of Kymab. “Since our foundation only seven 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.”
KY1005 has already shown outstanding preclinical 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.”
For further information contact:
Kymab:
David Chiswell, Chief Executive Officer
Anne Hyland, Chief Financial Officer
Tel: +44 (0)1223 833 301, Email: anne.hyland@kymab.com
Consilium Strategic Communications:
Mary-Jane Elliott / Jessica Hodgson / Laura Thornton
Tel: +44 (0) 20 3709 5700, Email: kymab@consilium-comms.com
