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Jacobio Completes First Patient Dosage of JAB-21822’s Phase II Pivotal Study in China

Sep 16, 2022

BEIJING, SHANGHAI and BOSTON, Sep. XX, 2022 -- Jacobio Pharma (1167.HK) announced it has completed first patient dosage of KRAS G12C inhibitor JAB-21822 in a Phase II pivotal study in China.

JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. The Phase II pivotal clinical trial in China will evaluate the efficacy and safety of JAB-21822 as a single agent for the treatment of NSCLC patients with a KRAS G12C mutation. This is a multi-center, single-arm, open-label study.

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) 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 Jacobio.

Jacobio aims to apply for the new drug marketing application (NDA) for JAB-21822 after the successful completion of this pivotal study.

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.

About Jacobio

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 located in Beijing, Shanghai and Boston, with a platform and expertise in developing allosteric inhibitors against protein tyrosine phosphatase, KRAS and transcriptional factors. Please visit www.jacobiopharma.com for more information.