#None #Chengdu #Keymed Biosciences #CM336 #Autoimmune Hemolytic Anemia

Keymed Biosciences Unveils Breakthrough Findings on CM336

On June 12, 2025, Keymed Biosciences Inc. (HKEX: 02162) announced significant findings from a clinical trial of CM336, focusing on its efficacy for patients suffering from autoimmune hemolytic anemia (AIHA). This research, led by Professor Jun Shi at the Institute of Hematology and Blood Diseases of the Chinese Academy of Medical Sciences, has been detailed in the prestigious New England Journal of Medicine (NEJM).

Study Overview

The publication titled "BCMA-Targeted T-Cell Engager for Autoimmune Hemolytic Anemia after CD19 CAR T-Cell Therapy" represents a crucial development in determining effective treatment options for AIHA patients. The study reports the outcomes of two patients who had previously faced a refractory status after multiple therapies including glucocorticoids, splenectomy, anti-CD20 antibodies, BTK inhibitors, and CD19 CAR T-cell therapies.

Study Findings

Remarkably, both patients exhibited rapid improvements post-administration of CM336. By day 13 and day 19 of treatment, respectively, they entered partial remission, with their hemoglobin levels returning to normal by day 17 and day 21. Moreover, significant reductions were noted in reticulocyte counts, lactate dehydrogenase levels, and indirect bilirubin rates.

The follow-up evaluation conducted six months after the treatment initiation revealed sustained remission for both subjects without the need for immunosuppressive therapies or blood transfusions. Importantly, no adverse effects such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or infections were reported during treatment or follow-up periods.

Implications of the Study

The overall findings of this clinical study suggest that CM336 may offer a promising new avenue for patients with recurrent or refractory AIHA, demonstrating not only rapid disease control but also prolonged remission without severe side effects. Its safety profile indicates its potential as an innovative treatment option for this challenging medical condition.

About CM336

CM336 is a bispecific antibody designed to engage both BCMA on targeted cells and CD3 on T-cells, effectively recruiting immune T-cells towards the targeted cells. This mechanism induces T-cell-mediated cytotoxicity, compelling the elimination of the targeted cells. Furthermore, clinical trials are set to commence, evaluating CM336 for primary light chain amyloidosis, which has received approval from the National Medical Products Administration of China. The implications of these studies extend beyond just AIHA, showcasing the versatility and promise of CM336 in broader hematologic diseases.

In summary, the latest findings from Keymed Biosciences mark a pivotal moment in the treatment landscape for patients with autoimmune hemolytic anemia, potentially opening doors for new therapies in their ongoing battle against this condition. As research progresses, the hope is to see constructively effective health outcomes for those enduring from AIHA and possibly other related diseases in the near future.