Jacobio Pharma Announces Breakthrough Therapy Designation from China CDE for KRAS G12C Inhibitor KRAS G12C Inhibitor Glecirasib for the Treatment of Pancreatic Cancer

2023-08-07

突破性疗法临床研究

BEIJING, SHANGHAI and BOSTON, Aug. 7, 2023 /PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, today announced that Jacobio's in-house KRAS G12C inhibitor KRAS G12C inhibitor glecirasib was granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the pancreatic cancer patients with a KRAS G12C mutation who have progressed after frontline standard care treatment. This BTD was granted based on the clinical efficacy and safety data from ongoing gleciracib clinical trials. The BTD will expedite the clinical development of glecirasib and accelerate its early access to the patients. Glecirasib's pivotal study for pancreatic cancer was approved by CDE in July 2023, which became the first global pancreatic cancer KRAS G12C registrational clinical study. The pivotal clinical trial will evaluate the efficacy and safety of single agent glecirasib in KRAS G12C-mutated locally advanced or metastatic pancreatic cancer patients who have progressed on frontline standard care treatment. This is a multi-center, single-arm, open-label study. Pancreatic cancer is a highly aggressive malignancy and with a limited effective treatment currently. The five-year overall survival rate is only 5%. Pancreatic cancer is glecirasib's second BTD indication in China. In December 2022, gleciracib was granted BTD for the second line setting and beyond of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation. About CDE's Breakthrough Therapy Designation CDE'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. About Glecirasib Glecirasib is a KRAS G12C inhibitor KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. This includes a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer. About Jacobio Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform. Company Codes: HongKong:1167

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机构

Center for Drug Evaluation