The Center for Drug Evaluation (CDE) website indicates that CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody drug conjugate (ADC) co-developed by Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd, has obtained breakthrough therapy designation (BTD) status. The designation is specifically for the drug’s potential use in CLDN18.2-positive advanced gastric cancer in patients who have failed or are intolerant to first-line treatment.
Previous Designations
CMG901 previously obtained orphan drug designation (ODD) and fast-track statuses in the US in April this year for use in gastric cancer and gastroesophageal junction cancer, respectively.
Mechanism of Action
CMG901 kills tumor cells through multiple mechanisms, having been shown to stimulate cellular and soluble immune effectors to limit activation of antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, thereby targeting and killing CLDN18.2-positive cells.
Preclinical and Clinical Studies
Preclinical studies have demonstrated that CMG901 is capable of killing gastric cancer tumor cells with higher potency than zolbetuximab analog or the unconjugated antibody of CMG901. The drug has shown a favorable safety and tolerability profile. A Phase I dose escalation study has been completed, and a Phase I expansion study is currently underway.-Fineline Info & Tech
