Drug Detail

Information about KTN0158

Generic Name
Brand Name (US)
Drug Type
monoclonal antibody
Approval Status
Phase 1
Overall Strategy
KIT Protein and immune system
Block KIT + Stimulate the immune system
Drug Category
KIT/PDGFRA inhibitor

The Company reported today that KTN0158 has been administered to the first cancer patient in a Phase 1 clinical trial following the acceptance by the U.S. Food and Drug Administration (FDA) of an IND application for KTN0158. KTN0158 is a potential first-in-class, humanized anti-KIT monoclonal antibody drug candidate discovered at Kolltan using structural insights obtained from the laboratory of Dr. Joseph Schlessinger at Yale University. In preclinical studies, KTN0158 has exhibited highly potent and selective inhibition of KIT expressed on cancer cells and mast cells, supporting its potential use in the treatment of cancers and other mast cell-related disorders. KTN0158 is the second clinical-stage program for Kolltan and is currently in an open-label, dose-escalating Phase 1 clinical trial focused on cancer patients with gastrointestinal stromal tumors (GIST) and other tumors expressing KIT. In 2015, the Company presented preclinical data supporting the potential use of KTN0158 in cancer through its direct impact on KIT as an oncogenic driver and through its immunomodulatory effects on mast cells and myeloid-derived suppressor cells (MDSCs), thereby potentially augmenting the effectiveness of T-cell checkpoint inhibitors. The Company expects that favorable safety, pharmacokinetic, pharmacodynamic and early tumor response data later this year would support expanded clinical trials of KTN0158 in cancer patients as a monotherapy and in combination with TKIs (tyrosine kinase inhibitors) and T-cell checkpoint inhibitor drugs.