KEYMED BIO-B (02162) has announced an update regarding its collaboration with AstraZeneca AB on the core product CMG901, also known as sonesitatug vedotin or AZD0901. As of the date of this announcement, AstraZeneca has initiated a multicenter, randomized, controlled Phase III clinical study named CLARITY-Gastric 02. This trial evaluates sonesitatug vedotin (AZD0901) in combination with capecitabine, with or without rilvegostomig, as a first-line treatment for Claudin 18.2 positive, HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. The first patient in this study has been dosed.

According to the terms of the licensing agreement, the dosing of the first patient in this clinical trial has triggered a milestone payment totaling $45 million. The group has received the payment from AstraZeneca, with the actual amount received net of bank charges.

CMG901 is an antibody-drug conjugate (ADC) targeting Claudin 18.2. It consists of a Claudin 18.2-specific antibody, a cleavable linker, and the cytotoxic payload monomethyl auristatin E (MMAE). It is the first Claudin 18.2-targeted ADC to have received clinical trial application approvals in both China and the United States. Claudin 18.2 expression is highly selective and widespread in gastric cancer, pancreatic cancer, and other solid tumors, making it an ideal target for cancer therapy.

In September 2022, CMG901 was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration for the treatment of Claudin 18.2-positive advanced gastric cancer in patients who have failed or are intolerant to first-line or later lines of therapy. Previously, CMG901 had received Orphan Drug Designation and Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory gastric cancer and gastroesophageal junction adenocarcinoma.

As of the announcement date, in addition to the trial mentioned above, AstraZeneca is conducting several other clinical studies on sonesitatug vedotin (AZD0901) for advanced solid tumors, including indications for gastric cancer, pancreatic cancer, and biliary tract cancer (only the highest clinical phase trial is listed for the same indication): (1) A multicenter, open-label, sponsor-blinded, randomized Phase III study (CLARITY Gastric 01) comparing AZD0901 monotherapy versus investigator's choice of therapy in adult subjects with Claudin 18.2-expressing advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma who have received two or more prior lines of therapy. (2) An open-label, multi-drug, multicenter Phase II study (GEMINI-PeriOp GC) evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of novel agents or combinations as perioperative treatment in subjects with locally advanced resectable gastroesophageal adenocarcinoma. (3) A Phase II, open-label, multicenter clinical study (CLARITY-PanTumour01) assessing the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of AZD0901 as a monotherapy and in combination with anti-cancer agents in subjects with Claudin 18.2-expressing advanced solid tumors, including gastric cancer/gastroesophageal junction adenocarcinoma, pancreatic cancer, and biliary tract cancer.