Jacobio Pharma announced that the clinical data of Glecirasib in combination with JAB-3312 was published in the form of a proffered paper presentation at the 2023 European Society for Medical Oncology Congress (ESMO 2023). Jacobio presented results of a Phase I/IIa study of glecirasib in combination With JAB-3312. The trial consisted of seven dose groups, including Glecirasib of 400 mg and 800 mg in combination with JAB- 3312 at different doses and dosing intervals, aiming to explore the safety, efficacy, and tolerability through different dose groups, and to provide a basis for a subsequent registrational clinical trial.

As of August 4, 2023, a total of 144 KRAS G12C mutant patients were enrolled, including 129 NSCLC patients, 14 patients with colorectal cancer, and 1 patient with pancreatic cancer. Among the 129 NSCLC (non-small cell lung cancer) patients involved in the trial, 107 patients had undergone at least one tumor assessment using RECIST1.1 criteria, and 58 of them were first-line therapy patients (spread across the seven dose groups), with an ORR of 65.5% (38/58) and a DCR of 100%. The ORR was 86.7% (13/15) in the dose group of 800 mg glcirasib in combinationwith 2 mg JAB-3312.

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 STK11co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer.

JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with glorectal cancer and other agents in China.