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Jacobio Pharma receives IND approval for KRAS G12C in China

Tuesday, December 7, 2021, 18:00 Hrs  [IST]

Jacobio Pharma has received the Investigational New Drug (the "IND") approval of the combination therapy of KRAS G12C inhibitor JAB-21822 and Cetuximab injection from the Center for Drug Evaluation of China (the "CDE")  on Dec 3, 2021.

After received the approval, Jacobio will start a phase I/II, open-label, multi-center, dose-escalation and expansion clinical trial in China. The clinical trial is aiming to explore the safety, tolerability and preliminary efficacy of the combination therapy of JAB-21822 and Cetuximab in KRAS G12C mutant patients with advanced colorectal cancer.

Jacobio's preclinical study shows that the combination therapy of JAB-21822 and Cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, make tumor regression, and delay tumor re-growth after the cessation of using the drug.

JAB-21822 has been approved for five clinical trials in China and the United States, including mono therapies and combination therapies with either PD-1 antibody or Cetuximab to treat KRAS G12C mutant patients with advanced solid tumors including non-small cell lung cancer  and colorectal cancer.


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