Jacobio Pharma’s in-house KRAS G12C inhibitor JAB-21822 has been granted breakthrough therapy designations in China.\n\n\n\nThe designations are for the second line and above treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation. The designations were granted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), based on the clinical efficacy and safety data of JAB-21822. It will help expedite the program registration to health authorities and accelerate early access to the patients.\n\n\n\nThe phase II pivotal clinical trial of Jacobio Pharma’s JAB-21822 was approved in China in September, 2022. The multi-center, single-arm, open-label study aims to evaluate the efficacy and safety of JAB-21822 as a single agent for the treatment of NSCLC patients with KRAS G12C mutation.\n\n\n\nClinical trials for Jacobio Pharma's JAB-21822 \n\n\n\nJacobio Pharma's JAB-21822 is the potential best-in-class program for KRAS G12C inhibitors. The preliminary phase I clinical data published at the 2022 annual meeting of the American Society of Clinical Oncology shows that as of April 1, 2022, 72 patients with advanced solid tumors were enrolled, and efficacy was assessed for 32 NSCLC patients with KRAS G12C mutation. The overall response rate (ORR) was 56.3% and the disease control rate (DCR) was 90.6%.\n\n\n\nJacobio Pharma's JAB-21822 has a good safety profile, and most treatment related adverse events (TRAE) were grade 1-2. Among the 72 patients, the incidences of diarrhea and vomiting were 5.6% and 6.9% respectively, and no gastrointestinal disorder higher than grade 2 was observed.\n\n\n\nCurrently, JAB-21822 is undergoing clinical trials for monotherapy and combination therapy in China, the U.S. and Europe, including the monotherapy for NSCLC patients with KRAS G12C mutation, pancreatic ductal carcinoma and colorectal cancer; the combination therapy with EGFR monoclonal antibody to treat patients with colorectal cancer; and the combination therapy with the inhouse SHP2 inhibitor JAB-3312 to treat patients with NSCLC.\n\n\n\nAbout CDE's Breakthrough Therapy Designation\n\n\n\nCDE's Breakthrough Therapy Designation (BTD) is designed to expedite the clinical development of innovative drugs presenting significant clinical advantages. A breakthrough therapy must provide effective treatment for a seriously debilitating or life-threatening condition that has no effective therapy or demonstrate substantial improvement over available therapies. According to the CDE, the breakthrough therapy designation provides opportunities for more intensive CDE guidance and discussion with respect to clinical trials and development strategy, and for priority review later.