Keymed Biosciences announces latest results from CM336 clinical trial

Overview

Keymed Biosciences Inc. (HKEX: 02162) announced that the research team of Professor Jun Shi from the Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) has recently published a research report titled "" BCMA-Targeted T-Cell Engager for Autoimmune Hemolytic Anemia after CD19 CAR T-Cell Therapy "" in the New England Journal of Medicine (NEJM), which has reported the research data on a BCMA x CD3 bispecific antibody treatment for patients with refractory autoimmune hemolytic anemia (AIHA) for the first time worldwide.

The study outcomes

• The study results showed that two patients experienced rapid disease improvement after CM336 administration, achieving partial remission on days 13 and 19, respectively. 

• Hemoglobin levels normalized on days 17 and 21, respectively, while reticulocyte counts, lactate dehydrogenase, and indirect bilirubin levels decreased significantly. 

• Prior to receiving CM336 treatment, both patients had undergone multiple treatment regimens, including glucocorticoids, splenectomy, anti-CD20 antibodies, BTK inhibitors, and CD19 CAR T cell therapies, but their disease eventually recurred or progressed to a refractory state. 

• Results of the final evaluation, 6 months after starting CM336, showed that both patients remained in sustained remission without immunosuppressive therapies or transfusions. 

• No cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or infectious events occurred throughout the treatment and follow-up period.

• The overall study showed that CM336 had demonstrated positive efficacy signals in the treatment of patients with relapsed/refractory AIHA who had previously received multiple therapies, with rapid disease control and sustained remission lasting more than half a year, while exhibiting a good safety profile, potentially making it an innovative treatment option for development in this disease.

About CM336

• CM336 is a BCMA x CD3 bispecific antibody that can simultaneously target, identify, and bind to both BCMA on the surface of target cells and CD3 receptors on the surface of T cells to recruit immune T cells near the target cells, thereby inducing T cell-dependent cellular cytotoxicity (TDCC) to eliminate them. 

• As of the date of this announcement, the Phase II clinical study of CM336 for the treatment of primary light chain amyloidosis has been approved by the Center for Drug Evaluation of the National Medical Products Administration, and clinical trials will commence shortly.

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