Beijing, Shanghai and Boston, Dec. 16 2022 — Jacobio Pharma (1167. HK) announced that the Company’s in-house KRAS G12C inhibitor JAB-21822 was granted breakthrough therapy designations for the second line and above treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation was granted based on the solid clinical efficacy and safety data of JAB-21822. It will help expedite the program registration to health authority and accelerate its early access to the patients.

The Phase II pivotal clinical trial of JAB-21822 was approved in China on September 5, 2022. The multi-center, single-arm, open-label study aims to evaluate the efficacy and safety of JAB-21822 as a single agent for the treatment of NSCLC patients with KRAS G12C mutation.

JAB-21822 is the potential best-in-class program for KRAS G12C inhibitors. The preliminary phase I clinical data published at the 2022 annual meeting of the American Society of Clinical Oncology 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).

JAB-21822 has a good safety profile, and most treatment related adverse events (TRAE) were grade 1-2. Among the 72 patients, the incidences of diarrhea and vomiting were 5.6% (4/72) and 6.9% (5/72) respectively, and no gastrointestinal disorder higher than grade 2 was observed.

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 patients with KRAS G12C mutation, pancreatic ductal carcinoma and colorectal cancer; the combination therapy with EGFR monoclonal antibody to treat patients with colorectal cancer; and the combination therapy with the inhouse SHP2 inhibitor JAB-3312 to treat patients with NSCLC.

About CDE's Breakthrough Therapy Designation
CDE’s Breakthrough Therapy Designation (BTD) is designed to expedite the clinical development of innovative drugs presenting significant clinical advantages. A breakthrough therapy must provide effective treatment for a seriously debilitating or life-threatening condition that has no effective therapy or demonstrate substantial improvement over available therapies. According to the CDE, the breakthrough therapy designation provides opportunities for more intensive CDE guidance and discussion with respect to clinical trials and development strategy, and for priority review later.

About JAB-21822
JAB-21822 is an oral, small molecule 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 harbouring KRAS G12C mutation with advanced solid tumors, including pivotal clinical trial to treat NSCLC in China; monotherapy for STK11 co-mutated NSCLC in the front-line setting; combination therapy with SHP2 inhibitor JAB-3312, anti-PD-1 monoclonal antibody and Cetuximab.

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