Keymed Biosciences Unveils Promising Clinical Trial Results for CM336 in Treating Refractory AIHA

On June 12, Keymed Biosciences Inc. (HKEX: 02162) made headlines by presenting the latest findings from their clinical trial of CM336. This breakthrough in treatment focuses on autoreactive hemolytic anemia (AIHA), a complex condition that affects many patients worldwide. The research team led by Professor Jun Shi from the Institute of Hematology at the Chinese Academy of Medical Sciences has recently published a crucial paper in the prestigious New England Journal of Medicine (NEJM).

The trial reported that patients with refractory AIHA, who previously underwent multiple treatment routes—including glucocorticoids, splenectomy, anti-CD20 antibodies, BTK inhibitors, and CD19 CAR-T cell therapies—showed significant improvement upon receiving CM336. Two patients reported rapid disease improvement after treatment, achieving partial remission as early as 13 and 19 days after administration. Noteworthy was the normalization of hemoglobin levels on days 17 and 21, accompanied by significant reductions in relevant biomarkers, including reticulocyte counts, lactate dehydrogenase levels, and indirect bilirubin levels.

Before commencing CM336 treatment, both subjects faced a history of recurrent or progressive AIHA post various therapeutic efforts. Remarkably, six months after initiating CM336, both patients remained in sustained remission without the need for immunosuppressive therapies or blood transfusions. The absence of adverse effects such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or infection events throughout the treatment period was another highlight of this study, showcasing CM336's favorable safety profile.

The findings suggest that CM336 demonstrates positive efficacy signals in treating recurrent or refractory AIHA, exhibiting rapid disease control and sustained remission for over six months while maintaining safety. This places CM336 as a potential innovative treatment option for managing AIHA moving forward.

Understanding CM336

CM336 is designed as a bispecific antibody targeting BCMA (B-cell maturation antigen) and CD3 (an essential T-cell receptor component), allowing it to bind simultaneously to both the targeted BCMA on malignant cells and the T-cells. This innovative design aims to recruit T-cells to the vicinity of the target cells, thus inducing T-cell dependent cellular cytotoxicity (TDCC) to facilitate their elimination.
The promise shown in preliminary studies has led to approval for further clinical investigation; a phase II trial for treating primary light chain amyloidosis with CM336 has been approved by the National Medical Products Administration, with trials expected to commence shortly.

The outcome of this study not only offers hope to patients with AIHA but also positions CM336 as a pioneer in the ongoing battle against autoimmune diseases, challenging the limitations imposed by current therapeutic options. As clinical trials progress, the medical community eagerly anticipates more in-depth insights into this innovative treatment and its broader implications for autoimmune hemolytic conditions.