China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced the first subject dosing in a Phase I clinical study for its in-house developed thrombopoietin receptor agonist, SCB-219M. This multi-center, dosage escalation and expansion study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic characteristics, and efficacy of SCB-219M in CIT patients. Interim safety data and Phase II recommended dose are expected during the first half of 2023.
Innovative Drug Development
SCB-219M is an innovative human thrombopoietin receptor agonist (TPO-RA) produced by CHO cells, developed through Clover’s Fc fusion protein technology platform. Preclinical studies have demonstrated that this injectable drug has a long serum half-life and favorable PK/PD characteristics, supporting the potential for weekly administration. This is a significant advancement as most standard treatments for CIT currently require daily injection or administration.
Understanding CIT and Current Treatments
Chemotherapy-induced thrombocytopenia (CIT) is an abnormal platelet count that commonly occurs in cancer patients undergoing chemotherapy. It can lead to treatment interruptions and serious bleeding events, negatively impacting the overall outcome of chemotherapy. In the United States and Europe, platelet transfusion is the primary treatment for CIT, providing only short-term platelet level stability. In China, the main treatment regimens involve the injection of recombinant human interleukin-11 (rhIL-11) and recombinant human thrombopoietin (rh-TPO). However, rh-TPO cannot be administered continuously for more than 14 days due to the risk of serious side effects from anti-drug antibodies (ADAs). Currently available TPO-RA products in China include Novartis’s Eltrombopag and Hengrui Medicine’s Herombopag, both oral small molecule non-peptide drugs requiring daily administration.-Fineline Info & Tech
