China Approves Jacobio's Phase III Trial for SHP2/KRAS G12C Combo Therapy

Jacobio Pharma, a clinical-stage oncology firm, has received approval for a registrational phase III clinical trial in China, combining its novel KRAS G12C inhibitor, glecirasib, with the innovative SHP2 inhibitor, JAB-3312. This marks the first time globally that a SHP2 inhibitor has entered a phase III study in tandem with a KRAS G12C inhibitor.

The phase III trial is designed to assess the efficacy and safety of the combined therapy for patients with non-small cell lung cancer (NSCLC) who have KRAS G12C mutations. The trial will compare the new treatment to the current standard of care, which involves a combination of PD-1 antibody therapy and chemotherapy.

Clinical trials for SHP2 inhibitors began at Jacobio in 2018. Data shared at ESMO 2023 indicated promising results. Out of 129 NSCLC patients, 58 were receiving first-line treatment across seven dosage groups. The objective response rate (ORR) was 65.5%, and the disease control rate (DCR) was 100%. Notably, in a specific dosage group, the ORR reached 86.7%. Patient enrollment for the study is ongoing.

Currently, no KRAS G12C inhibitors are approved for first-line NSCLC treatment for KRAS G12C mutations. Both JAB-3312 and glecirasib are oral medications, and their combined use represents the first phase III clinical trial for dual oral inhibitors as a first-line NSCLC treatment globally.

JAB-3312 is recognized as a highly selective SHP2 allosteric inhibitor, with the potential to be a leading product in its class. Jacobio is conducting clinical trials for JAB-3312 both as a monotherapy and in combination with other treatments, including glecirasib, across China, the United States, and Europe. The phase III study combining it with the KRAS G12C inhibitor glecirasib received approval from China's Center for Drug Evaluation in February 2024.

Glecirasib, developed by Jacobio, is undergoing several Phase I/II clinical trials for patients with advanced solid tumors that have the KRAS G12C mutation. Trials include a pivotal NSCLC study in China, a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with JAB-3312 in NSCLC and Cetuximab in colorectal cancer.

Jacobio Pharma is dedicated to developing innovative products and solutions to enhance public health. The company focuses on six major signaling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB, and MYC. Jacobio aims to be a top global leader in drug research and development, with R&D centers in Beijing, Shanghai, and Boston, utilizing the Induced Allosteric Drug Discovery Platform (IADDP) and the iADC Platform.