Beijing, Shanghai & Boston, Oct. 27 2023— Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, announced it has completed first patient dosage of it’s in-house KRAS G12C inhibitor glecirasib in a pivotal clinical trial for pancreatic cancer patients in leading site Peking Union Medical College Hospital.

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. This study is planned to be conducted in approximately 40 sites across the country. 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. The study results will be used to submit NDA (New Drug Application) for pancreatic cancer.

In August 2023, 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%. The BTD will expedite the clinical development of glecirasib and accelerate its early access to the patients.

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