KRAS p.G12C mutant pancreatic cancer

BEIJING and SAN FRANCISCO, Jan. 19, 2024 /PRNewswire/ -- Jacobio Pharmaceuticals (1167.HK), a clinical-stage oncology company focusing on undruggable targets, announced data of glecirasib in patients with pancreatic cancer and other solid tumors in the oral abstract session at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (" 2024 ASCO GI"). As of December 6, 2023, the monotherapy global study of glecirasib enrolled 52 patients with pancreatic cancer and other solid tumors harboring KRAS G12C mutation in China, the United States, Europe, Israel and other regions, including 31 patients with pancreatic cancer, and 21 patients with other solid tumors (8 with biliary tract tumors, 3 with gastric cancer, 3 with small bowel cancer, 2 with appendix cancer, and 5 with other solid tumors). Among 50 patients with evaluable solid tumors, the confirmed objective response rate (cORR) was 48% (24/50) and the disease control rate (DCR) was 90% (45/50). For second-line and above KRAS G12C mutated pancreatic cancer patients, the cORR was 41.9% (13/31) and the DCR was 93.5% (29/31). The median progression-free survival (mPFS) was 5.6 months, and the median overall survival (mOS) was 10.7 months. In other solid tumor patients, the cORR was 57.9% (11/19), DCR was 84.2% (16/19), the mPFS was 7.0 months, and the mOS has not yet matured. The above safety and efficacy data are better than the published data of similar studies. Glecirasib has good tolerability and safety characteristics, the majority of treatment-related adverse events (TRAEs)are grades 1-2, and grade 3 or above TRAEs occurred in 25% of patients. No patient has permanently withdrawn from the study due to TRAE. Professor Lin Shen, director of Peking University Cancer Hospital gastroenterology department, is the principal investigator for this trial. She introduced at the conference, "Pancreatic cancer is a highly malignant tumor, and current patients lack effective standardized treatment methods, with a five-year overall survival rate of only 5%. Every year in China, nearly 1-2% of pancreatic cancer patients carry a KRAS G12C mutation, and the mutation rate in other solid tumors is also around 1%. The clinical data of glecirasib have preliminarily confirmed the efficacy in patients with pancreatic cancer and other solid tumors. Compared with the standard chemotherapy treatment, the ORR of glecirasib is higher, and the safety and tolerance is better. It is expected that glecirasib will accelerate the clinical development in pancreatic cancer and other solid tumors, bringing a better treatment option beyond chemotherapy for patients." Jacobio continues to explore the application of glecirasib in pancreatic cancer. Glecirasib's registrational 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 study results will be used to submit NDA (New Drug Application) for pancreatic cancer. Based on the clinical efficacy and safety data from ongoing clinical trials, 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. Pancreatic cancer is a malignant tumor and there is a lack of effective treatment currently. The five-year overall survival rate is only 5%-10%. The BTD will expedite the clinical development of glecirasib and accelerate its early access to the patients. For more information, please visit the official website of the ASCO GI: Conference Call Information Jacobio will host a live conference call on Jan. 23, 2024, at 9:30-10:30 (UTC+8). Participants must register in advance of the conference call. Registration Link: About Glecirasib Glecirasib is a 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 (patients enrollment has been completed); a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer, and a registrational pivotal clinical trial in pancreatic cancer. About Jacobio Pharma 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. SOURCE Jacobio Pharma

Glecirasib is intended for the treatment of pancreatic cancer patients with the KRAS G12C mutation. Credit: Nemes Laszlo/Shutterstock.com. Jacobio Pharma has received breakthrough therapy designation (BTD) for glecirasib to treat pancreatic cancer patients with the KRAS G12C mutation. The company’s in-house KRAS G12C inhibitor received the designation from the Center for Drug Evaluation of China’s National Medical Products Administration. Recommended Reports Reports Innovation in Pharmaceuticals: Cyclosporin derivatives GlobalData Reports Innovation in Pharmaceuticals: Periodontitis drugs GlobalData View all The BTD has been granted based on the results from an ongoing pivotal, multi-centre, single-arm, open-label study that assessed the safety and efficacy of the single agent glecirasib. Patients with KRAS G12C-mutated locally advanced or metastatic pancreatic cancer who progressed on frontline standard care treatment were enrolled in the trial. In December 2022, glecirasib received the first BTD for treating advanced or metastatic non-small cell lung cancer (NSCLC) patients with the KRAS G12C mutation. Jacobio is also currently conducting a pivotal Phase I/II monotherapy study in China evaluating glecirasib in STK11 [a germline mutation] co-mutated NSCLC patients in the front-line setting. Combination therapy trials of glecirasib with SHP2 inhibitor JAB-3312 to treat NSCLC and with Cetuximab for colorectal cancer are also being carried out in the country. Other Phase I/II clinical trials of glecirasib are ongoing in Europe and the US for treating patients with advanced solid tumours harbouring the KRAS G12C mutation. The company also develops new molecules that target immune checkpoints, tumour metabolism and P53, RB and MYC-signalling pathways.

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 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 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 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