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Jacobio Receives IND Approval for Combination Therapy of KRAS G12C and Cetuximab Injection in China
BEIJING and SHANGHAI and BOSTON, Dec. 5, 2021 /PRNewswire/ -- Jacobio Pharma (1167.HK) 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.
JAB-21822 is the Jacobio's in-house innovative small molecule anti-cancer drug, which is designed to target KRAS G12C mutation. JAB-21822 has best-in-class potential among KRAS G12C inhibitors and has been approved for clinical trials in China and the United States. Internal pre-clinical head-to-head studies have shown that JAB-21822 has a superior pharmacokinetic (PK) profile and favorable tolerability as well as potential for a superior dosing profile compared with its competitors.
Cetuximab is an IgG1 monoclonal antibody against the EGF receptor. The cetuximab injection used in the clinical trial of the combination therapy is an approved treatment for RAS wild type patients with metastatic colorectal cancer, head and neck cancers and other diseases.
Jacobio is committed to providing more products and solutions to people's health. Our mission is to provide compelling innovations for creating a pipeline of life-changing medicines. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. The company's R&D centers are in Beijing, Shanghai and Massachusetts, with a platform and expertise in developing allosteric inhibitors against protein tyrosine phosphatase, KRAS and transcriptional factors.