China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its pipeline candidate KYS202002A, focusing on recurrent/refractory multiple myeloma (R/R MM). This follows the molecule’s approval for clinical trials in China in January this year.
KYS202002A: A Monoclonal Antibody Targeting CD38
The Category 1 biologic product, KYS202002A, is a monoclonal antibody (mAb) with high affinity for the CD38 protein. It is capable of binding to tumor cells that express CD38 and mediating tumor killing and tumor cell apoptosis through various immune mechanisms. This innovative approach has the potential to transform treatment options for patients with R/R MM.
Pharmacodynamics and Toxicological Studies
Animal pharmacodynamics in vivo studies have demonstrated that KYS202002A has a significant inhibitory effect on tumor growth in multiple myeloma and lymphoma models with high expression of CD38. Toxicological studies have shown that single and multiple administrations of KYS202002A injection to cynomolgus monkeys did not result in drug-mediated non-specific toxic reactions, indicating good tolerability.
Market Context and Competition
Globally, there are two CD38 mAbs commercially available: Janssen Pharmaceuticals’ Darzalex (daratumumab) and Sanofi’s Sarclisa (isatuximab). The advancement of KYS202002A towards clinical trials positions Jiangsu Kanion Pharmaceutical to potentially join this competitive landscape, offering a new treatment option for patients with multiple myeloma.-Fineline Info & Tech
