Clover Announces Positive Phase Ⅰ Results for SCB-219M for Treatment of Chemotherapy-Induced Thrombocytopenia (CIT)
--All CIT patients maintained platelet counts >75 x 109/L at 1-week following chemotherapy plus a single dose of SCB-219M, with durable responses through at least 3-weeks--
--Durable efficacy and PK profile expected to support convenient dosing interval of ≥2-weeks, compared to daily or weekly dosing for current treatment options in
--Phase Ⅰb trial in CIT and CTIT (cancer treatment-induced thrombocytopenia) patients evaluating repeated dosing of SCB-219M is planned to initiate in 2024--
All cancer patients enrolled to-date (n=9) receiving chemotherapy plus a single subcutaneous dose of SCB-219M observed platelet counts maintained or recovered at >75 x 109/L (threshold level for CIT) after one week, with responses durable through at least three weeks (i.e. through the chemotherapy cycle). In comparison, following administration of the same chemotherapy (but without SCB-219M) in the same cancer patients prior to enrolling into the trial, all evaluable patients had observed platelet counts drop to <75 x 109/L between one and three weeks. The durable preliminary efficacy and pharmacokinetic profile observed for SCB-219M are potentially supportive of dosing intervals ≥2-weeks. If further confirmed, this profile could enable convenient dosing of SCB-219M synchronized with any given patient's chemotherapy regimen, typically 2-3 weeks per cycle. A favorable safety and tolerability profile for SCB-219M has also been observed to-date, with no serious adverse events (SAEs) and no dose-limiting toxicity (DLT) identified.
Dr.
"We are pleased to announce positive Phase Ⅰ results for SCB-219M demonstrating rapid and durable efficacy along with a favorable safety profile," said Dr.
The Phase Ⅰ trial is a multi-center, open-label, dose escalation and dose expansion study, that is exploring the safety, tolerability, immunogenicity, pharmacokinetics, and efficacy of SCB-219M administered subcutaneously in cancer patients with CIT. In addition to
CIT is a serious, chemotherapy-associated complication observed in a wide range of cancer patients. Incidence of CIT can occur in greater than 50%[3] of patients undergoing standard chemotherapy regiments, and can have detrimental impacts on treatment outcome, resulting in chemotherapy dose delay or dose reduction, and potentially fatal bleeding events.
1. TPIAO (3SBio; https://ypk.39.net/666055/manual). 2. Nplate; romiplostim (https://doi.org/10.3324/haematol.2020.251900; https://doi.org/10.1200/JCO.18.01931). 3. |
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SOURCE Clover Biopharma
Elaine Qiu, elaine.qiu@cloverbiopharma.com