Kymab Announces Promising Results from Initial Clinical Study of New Antibody KY1005 for Treatment of Autoimmune Diseases
· Top-line Phase I data demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that support advancement of KY1005 into patient Phase 2 studies
· KY1005, a fully human monoclonal antibody, is an antagonist of OX40-Ligand (OX40L) with the potential to treat a number of immune mediated and inflammatory disorders (autoimmune diseases)
· The study demonstrated an early proof of mechanism of action, as KY1005 was seen to block T-cell-driven inflammation in the skin
Cambridge, UK; 30 July 2018: Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibody therapeutics, announces today that it has obtained positive data in its Phase I trial of KY1005 and will proceed to Phase II studies in atopic dermatitis, with additional plans to run studies in other immune-mediated diseases, such as Graft-versus-Host Disease (GvHD).
Results from the Phase I study demonstrate that KY1005 had a favorable safety profile and was well-tolerated. In addition, KY1005 was shown to block T-cell-driven inflammation in the skin of healthy volunteers. The study was a single and multiple ascending-dose, placebo-controlled, double-blind, Phase I study in 64 healthy volunteers.
“KY1005 is an exciting potential therapeutic for several indications and we are delighted to have obtained such encouraging Phase I data, paving the path to further clinical development,” said Dr. Sonia Quaratino, Chief Medical Officer. “With the initial safety and dosing information from this trial, we are now ready to begin dosing atopic dermatitis patients to further assess tolerability and preliminary efficacy.”
KY1005 targets OX40L which, with its receptor OX40, plays a central role in the development of multiple inflammatory and autoimmune diseases, making OX40L blockade an attractive therapeutic option for those diseases maintained by prolonged T-cell responses in which a “resetting” of the immune system is needed.
In its next clinical study, KY1005 will be tested in patients with atopic dermatitis, a condition in which especially high levels of OX40L are found. The Phase IIa trial in atopic dermatitis is expected to begin in late 2018.
Studies in other immune-related diseases, including GvHD, will follow. KY1005 has the potential to transform the outcome of stem cell transplantation through prevention of acute GvHD, acting to inhibit early T-cell expansion post-transplantation. In a study in 2017, KY1005 in combination with sirolimus showed extraordinary efficacy in the prevention of acute GvHD in a non-human primate model of a stem cell transplant (also known as bone marrow transplant), and clinical studies in GvHD are planned for 2019.