Chinese biotechnology company Clover Biopharmaceuticals has reported positive initial results from a Phase I clinical trial of its new therapy, SCB-219M, for chemotherapy-induced thrombocytopaenia (CIT).
The open-label dose escalation and dose expansion trial was designed to evaluate the tolerability, immunogenicity, safety, efficacy and pharmacokinetics of a subcutaneous dose of SCB-219M in cancer patients with CIT.
It enrolled nine subjects who were given chemotherapy with one dose of SCB-219M.
According to the results, the platelet counts were maintained or recovered above the CIT’s threshold level following one week, with the effect lasting for a minimum of three weeks.
In addition, SCB-219M’s pharmacokinetic and efficacy profile shows the possibility of having dosing intervals of two weeks or more.
This could allow the treatment to be administered during patients’ chemotherapy cycles, which usually last for two to three weeks.
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The treatment also showed a favourable safety and tolerability profile, with no serious adverse events or dose-limiting toxicities being recorded.
Clover Biopharmaceuticals chairman, chief scientific officer and SCB-219M inventor Dr Peng Liang said: “We are pleased to announce positive Phase I results for SCB-219M demonstrating rapid and durable efficacy along with a favourable safety profile.
“The preliminary results suggest that SCB-219M has a potentially differentiated profile compared to the current standard of care treatments for CIT and cancer treatment-induced thrombocytopaenia (CTIT).
“In contrast to current biologic treatment options for CIT in China requiring daily injectionsand globally requiring weekly injections, the durable efficacy and pharmacokinetics of SCB-219M observed to-date could enable convenient dosing synchronised with any given patient’s chemotherapy regimen.”
Clover plans to begin a Phase Ib clinical trial evaluating repeated doses of SCB-219M in CIT and CTIT patients this year.
The company currently has a diverse pipeline of drug candidates designed to reduce the vaccine-preventable disease burden.