Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has published results from an exploratory clinical study on its Category 1 drug CM313 in the New England Journal of Medicine. CM313 is a CD38-targeted monoclonal antibody (mAb) being investigated for the treatment of primary immune thrombocytopenia (ITP). The study is titled “A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia.”
The investigator-initiated, single-arm, open-label, exploratory study aimed to assess the safety and preliminary efficacy of CM313 in ITP patients, enrolling 22 subjects. All but one patient completed the study, receiving 8 doses of CM313 over 16 weeks. In terms of efficacy, 95.5% of patients (21/22) achieved a platelet count of ≥ 50 × 109/L within 8 weeks after the first dose, with a median cumulative time of ≥ 50 × 109/L for 23 weeks. The persistent platelet response rate, defined as 6 or more platelet counts observed in the last 8 platelet counts ≥ 50 × 109/L, was 63.6% (14/22). All 21 patients achieved an overall response (OR) during the study period, with 20 patients achieving a complete response (CR). The proportion of patients with bleeding symptoms decreased significantly from 68.2% at baseline to 4.8% in the 8th week. Most concomitant medications were discontinued as platelet counts recovered to normal or safe levels after treatment with CM313. The safety profile of the molecule was also found to be favorable.
Previously, Phase I data for CM313 in recurrent/refractory (R/R) multiple myeloma (MM) and lymphoma were presented at the 28th European Hematology Association (EHA) annual meeting in 2023.- Flcube.com
