Keymed Biosciences Unveils Promising Clinical Trial Results of CM336 for Autoimmune Hemolytic Anemia
In a remarkable advancement within the medical field, Keymed Biosciences Inc. (HKEX: 02162) has disclosed notable findings from its clinical study on CM336, recently published in the prestigious New England Journal of Medicine. Conducted by Professor Jun Shi’s research team at the Institute of Hematology and Blood Diseases Hospital, this study is the first to provide insights into the efficacy of a BCMA x CD3 bispecific antibody treatment aimed at patients suffering from refractory autoimmune hemolytic anemia (AIHA).
The trial results showcase that two patients experienced swift improvements following the administration of CM336, with one achieving partial remission as early as day 13 and the other by day 19. Remarkably, the hemoglobin levels for both individuals returned to normal ranges by days 17 and 21, while key markers such as reticulocyte count, lactate dehydrogenase, and indirect bilirubin levels saw significant reductions.
Prior to their treatment with CM336, these patients had undergone numerous other therapies, including glucocorticoids, splenectomy, anti-CD20 monoclonal antibodies, BTK inhibitors, and CD19 CAR-T cell treatments, all of which were ineffective against their AIHA which either recurred or remained resistant. Follow-up evaluations after six months revealed that both patients maintained sustained remission without the need for immunosuppressive therapies or blood transfusions. Throughout the treatment and observation period, there were no occurrences of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or any infectious events.
The overall findings indicate that CM336 demonstrates promising effectiveness for patients suffering from recurrent or refractory AIHA post multiple treatment regimes. The drug not only induced rapid disease control but also resulted in lasting remission lasting over six months, while concurrently displaying a favorable safety profile. Such attributes underline CM336’s potential as an innovative treatment option for this challenging blood disorder.
For context, CM336 represents a novel BCMA x CD3 bispecific antibody designed to simultaneously target BCMA on the surface of target cells and CD3 receptors on T cells. This dual engagement recruits T cells to the vicinity of target cells, facilitating T cell-dependent cellular cytotoxicity (TDCC) to eliminate diseased cells effectively. As of this announcement, the clinical phase-II trial of CM336 for treating primary light-chain amyloidosis has been authorized by the Center for Drug Evaluation under the National Medical Products Administration, with clinical studies anticipated to commence shortly.
The implications of this study not only disrupt current paradigms of treating AIHA but may also pave the way for future developments in therapies addressing similar conditions, marking a beacon of hope for countless patients enduring the ramifications of autoimmune diseases. Keymed Biosciences stands at the forefront of innovative solutions, reinforcing their commitment to advancing medical research and developing therapies that could transform treatment standards in hematology and beyond.
The trial results showcase that two patients experienced swift improvements following the administration of CM336, with one achieving partial remission as early as day 13 and the other by day 19. Remarkably, the hemoglobin levels for both individuals returned to normal ranges by days 17 and 21, while key markers such as reticulocyte count, lactate dehydrogenase, and indirect bilirubin levels saw significant reductions.
Prior to their treatment with CM336, these patients had undergone numerous other therapies, including glucocorticoids, splenectomy, anti-CD20 monoclonal antibodies, BTK inhibitors, and CD19 CAR-T cell treatments, all of which were ineffective against their AIHA which either recurred or remained resistant. Follow-up evaluations after six months revealed that both patients maintained sustained remission without the need for immunosuppressive therapies or blood transfusions. Throughout the treatment and observation period, there were no occurrences of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or any infectious events.
The overall findings indicate that CM336 demonstrates promising effectiveness for patients suffering from recurrent or refractory AIHA post multiple treatment regimes. The drug not only induced rapid disease control but also resulted in lasting remission lasting over six months, while concurrently displaying a favorable safety profile. Such attributes underline CM336’s potential as an innovative treatment option for this challenging blood disorder.
For context, CM336 represents a novel BCMA x CD3 bispecific antibody designed to simultaneously target BCMA on the surface of target cells and CD3 receptors on T cells. This dual engagement recruits T cells to the vicinity of target cells, facilitating T cell-dependent cellular cytotoxicity (TDCC) to eliminate diseased cells effectively. As of this announcement, the clinical phase-II trial of CM336 for treating primary light-chain amyloidosis has been authorized by the Center for Drug Evaluation under the National Medical Products Administration, with clinical studies anticipated to commence shortly.
The implications of this study not only disrupt current paradigms of treating AIHA but may also pave the way for future developments in therapies addressing similar conditions, marking a beacon of hope for countless patients enduring the ramifications of autoimmune diseases. Keymed Biosciences stands at the forefront of innovative solutions, reinforcing their commitment to advancing medical research and developing therapies that could transform treatment standards in hematology and beyond.
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