On September 1, 2022 Jacobio Pharma (1167.HK) reported that the company has dosed the first non-small cell lung cancer (NSCLC) patient with KRAS G12C and STK11 co-mutation in the Phase IIa trial of KRAS G12C inhibitor JAB-21822 in China (Press release, Jacobio Pharmaceuticals, SEP 1, 2022, View Source [SID1234618957]).

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JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio utilizing the allosteric inhibitor technology, which is now used as the front-line treatment for advanced or metastatic NSCLC patients with KRAS G12C and STK11 co-mutation.

In China, there are approximately 40,000 new patients with tumors harboring KRAS G12C mutation every year. STK11 is an in-parallel biomarker of KRAS G12C. According to relevant studies, non-small cell lung cancer patients with STK11 and KRAS G12C co-mutation receiving KRAS G12C inhibitor treatment have a higher objective response rate in clinical study.

"JAB-21822 is the first and only clinical stage drug approved for first-line treatment of STK11 and KRAS G12C co-mutated non-small cell lung cancer in China. JAB-21822 is independently developed by Jacobio, which has potential to bring better treatment options to patients based on efficacy and safety," said Dr. WANG Yinxiang, Chairman and CEO of Jacobio.

JAB-21822 is the best-in-class potential project for KRAS G12C inhibitors. The preliminary clinical date of the Phase I study of JAB-21822 published at the 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) shows that as of April 1, 2022, a total of 72 patients with advanced solid tumors were enrolled, and efficacy was assessed for 32 NSCLC patients with KRAS G12C mutation. The overall response rate (ORR) was 56.3% (18/32) and the disease control rate (DCR) was 90.6% (29/32).

Currently, JAB-21822 is simultaneously undergoing clinical trials for monotherapy and combination therapy in China, the United States and Europe, including the monotherapy for NSCLC with KRAS G12C mutation, pancreatic ductal carcinoma and colorectal cancer; the combination therapy with EGFR monoclonal antibody; and the combination therapy with JAB-3312, a self-developed SHP2 inhibitor of the Company.

About JAB-21822

JAB-21822 is a KRAS G12C inhibitor independently developed by the Company. The Company has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer in the front-line setting; combination therapy with SHP2 inhibitor, anti-PD-1 monoclonal antibody and Cetuximab.