KN035 is an investigational monoclonal antibody for the treatment of cancer. It is manufactured by Alphamab and 3D Medicines is responsible for the clinical development, registration, and marketing of the product.
How KN035 works
KN035 is directed against programmed cell death ligand-1 (PD-L1), which is a transmembrane protein expressed on the surface of healthy cells. PD-L1 normally functions by binding to a receptor protein called PD1 (or programmed cell death 1) found on the surface of specialized immune cells called T-cells. The binding of PD-L1 to PD-1 limits the expansion and survival of T-cells, ensuring they do not mistakenly attack healthy cells. However, PD-L1 also is overproduced by many human cancer cells allowing them to evade immune detection.
Once administered, KN035 binds to PD-L1, blocking it from binding to PD-1. This may lead to an increase in the immune response by T-cells against cancer cells.
KN035 in clinical trials
A Phase 1 study (NCT03101488) is recruiting participants with advanced solid tumors in China to assess the tolerability and safety of KN035 as a single agent. The trial aims to recruit 36 participants and the estimated study completion date is March 2019.
An open-label, dose escalation Phase 1 study (NCT02827968) is recruiting participants in the U.S. with locally advanced or metastatic solid tumors. It also will assess the safety and tolerability of KN035 and aims to enroll 24 participants. It is estimated the study will be completed by January 2019.
A Phase 1 study (NCT03248843) will test the safety and pharmacokinetics (the movement inside the body) of KN035 injected under the skin in Japanese patients with locally advanced or metastatic solid tumors. The study is not yet open for recruitment, but plans to enroll 18 participants and be completed by December 2018.
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