Jacobio Receives CDE Approval for Glecirasib's Pancreatic Cancer Pivotal Study in China

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Jul 04, 2023, 09:16 ET

BEIJING, SHANGHAI and BOSTON, July 4, 2023 /PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its novel KRAS G12C inhibitor glecirasib's pivotal study for pancreatic cancer has been approved from CDE (Center for Drug Evaluation), which became the first global pancreatic cancer registrational clinical study for KRAS G12C.

The pivotal clinical trial approved in China will evaluate the efficacy and safety of Glecirasib as a single agent for the second line treatment or above of Pancreatic Cancer patients with a KRAS G12C mutation. 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.

"The pivotal study of pancreatic cancer is the second approved registrational study after non-small cell lung cancer", said gastrointestinal oncology expert Dr. Andrea Wang-Gillam, the Chief Medical Officer of Jacobio, "We hope to work with clinical study investigators to jointly advance the clinical trials and strive to bring more treatment options to cancer patients with KRAS G12C-mutated as soon as possible."

Pancreatic cancer is a malignant tumor and there is a lack of effective treatment currently. The five-year overall survival rate is only 5%. About 90% of pancreatic cancer patients have different types of KRAS mutations. Besides KRAS G12C inhibitor glecirasib, Jacobio is developing KRAS^multi, KRAS G12D and other projects, which are expected to benefit more pancreatic cancer patients.

About Glecirasib
Glecirasib is Jacobio's novel KRAS G12C inhibitor. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors harbouring KRAS G12C mutation, including a pivotal clinical trial int NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting; combination therapy trials with SHP2 inhibitor JAB-3312, anti-PD-1 antibody and Cetuximab.

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.

SOURCE Jacobio Pharma