China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its pipeline candidate KYS202002A in recurrent/refractory multiple myeloma (R/R MM). This marks a significant step forward in the development of this innovative therapy targeting a challenging form of cancer.
Mechanism and Preclinical Profile
KYS202002A is a Category 1 biologic product and a monoclonal antibody (mAb) with high affinity for the CD38 protein. The antibody is designed to bind to tumor cells expressing CD38 and mediate tumor killing and apoptosis through various immune mechanisms. Preclinical pharmacodynamics studies in animal models demonstrated significant inhibitory effects on tumor growth in multiple myeloma and lymphoma models with high CD38 expression. Toxicological studies in cynomolgus monkeys showed that single and multiple administrations of KYS202002A did not cause non-specific toxic reactions, indicating good tolerability.
Market Landscape and Competitive Environment
There are currently two CD38-targeting mAbs commercially available globally: Janssen Pharmaceuticals’ Darzalex (daratumumab) and Sanofi’s Sarclisa (isatuximab). Darzalex was first approved in the US in November 2015 as a fourth-line treatment for R/R MM and later as a first-line treatment in combination with lenalidomide, dexamethasone, or bortezomib. The drug has been approved in over 70 countries and received conditional marketing approval in China in July 2019, entering the National Reimbursement Drug List (NRDL) in 2021. Sarclisa was approved in the US in March 2020 for R/R MM patients who have received at least two prior treatments, including lenalidomide and a proteasome inhibitor, in combination with pomalidomide and dexamethasone.
Future Outlook
The approval for the clinical study of KYS202002A highlights Jiangsu Kanion’s commitment to advancing novel treatments for multiple myeloma. With demonstrated preclinical efficacy and safety, KYS202002A has the potential to address significant unmet needs in the treatment of R/R MM. Jiangsu Kanion’s ongoing research and development efforts underscore its dedication to improving patient outcomes in oncology.-Fineline Info & Tech
