• EN

Jacobio Announces China CDE Clearance for Phase III Clinical Trial of KRAS G12C Inhibitor Glecirasib in Patients with Colorectal Cancer

May 10, 2024

Beijing, Shanghai, Boston, May 10, 2024—Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, today announced it received approval of registrational phase III clinical trial of the combination therapy between its novel KRAS G12C inhibitor glecirasib and cetuximab in patients with KRAS G12C-mutated colorectal cancer recently.

This approved registrational phase III trial in China aims to evaluate efficacy and safety of glecirasib in combo with cetuximab versus positive control treatment in colorectal cancer patients with unresectable or metastatic KRAS G12C mutations. In October 2022, Jacobio entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio’s KRAS G12C inhibitor glecirasib and Merck’s epidermal growth factor receptor (EGFR) inhibitor Erbitux® (cetuximab). Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement.

In June 2023, Jacobio announced clinical results of glecirasib in combination therapy with cetuximab to treat KRAS G12C mutant advanced colorectal cancer in Second JCA- AACR Precision Medicine International Conference. In a trial of glecirasib with cetuximab, the overall response rate (ORR) is 62.8% (27/43), the disease control rate (DCR) is 93% (40/43). The majority TRAEs (treatment related adverse event) are grades 1-2.

Colorectal cancer is the second most common cancer in China, with about 550,000 new cases per year, of which about 3% of colorectal cancer patients have KRAS G12C mutation. Patients with KRAS G12C mutation are insensitive to existing standard chemotherapies and targeted therapies, have rapid disease progression, short survival, and they have high unmet clinical treatment needs. Glecirasib has potential to bring effective and less toxic treatment option for 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. These include 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. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.

About ERBITUX® (cetuximab) 
ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX has  obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.

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.