Gelonghui, December 29 | Clover Bio-B (02197.HK) announced that positive preliminary safety, efficacy, and pharmacokinetics data were obtained in a phase I clinical trial evaluating a new class of drugs SCB-219M. SCB-219M is an innovative bispecific Fc fusion protein-targeting drug containing a thrombocytopenic receptor agonist (TPO-RA) modeptide produced by CHO cells for thrombocytopenia (“CIT”) induced by chemotherapy in cancer patients.
This phase I clinical trial is a multicenter, open, dose climbing and dose amplification study to explore the safety, tolerability, immunogenicity, pharmacokinetic characteristics and efficacy of SCB-219M subcutaneous injection in CIT patients. Research centers participating in this clinical trial include the Oncology Center of West China Hospital of Sichuan University, Sichuan Provincial People's Hospital, and Chengdu Sixth People's Hospital. Clover Biotech plans to launch a phase Ib clinical trial in 2024 to evaluate repeated administration of SCB-219M in CIT and CTIT (thrombocytopenia due to tumor treatment) patients.
CIT is a serious chemotherapy-induced complication that can occur widely in cancer patients. The incidence of CIT can exceed 50% in patients receiving standardized treatment regimens, and can have serious adverse effects on treatment outcomes, leading to delayed chemotherapy or reduced chemotherapy doses, and potentially fatal bleeding events.