Pharma Focus Asia

Kymab Announces Promising Results from Initial Clinical Study of New Antibody KY1005 for Treatment of Autoimmune Diseases

Monday, July 30, 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.

Latest Issue
Get instant
access to our latest e-book
MFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Gibco Adherent Kidney Media PanelCPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024ISPE Singapore Affiliate Conference & Exhibition 2024Rehab Expo 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024