Jacobio KRAS G12C inhibitor JAB-21822 received CDE breakthrough therapy designation

Jacobio Pharmaceuticals (1167.
HK), the KRAS G12C inhibitor JAB-21822, was awarded breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Administration of Supervision (NMPA) of China for the second-line and above treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation
.
This designation is based on the good efficacy and safety characteristics of JAB-21822 in the early stage, and the designation of breakthrough therapy will help accelerate the review and registration of drugs and accelerate the early access of patients to drugs
.

The Phase II pivotal clinical trial of JAB-21822 was approved
in China on September 5, 2022.
This multicenter, single-arm, open-label study aims to evaluate the efficacy and safety
of JAB-21822 monotherapy in patients with KRAS G12C mutation-free non-small cell lung cancer.

JAB-21822 is a potential best-in-class program
among KRAS G12C inhibitors.
Phase I clinical data of JAB-21822 presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting showed that as of April 1, 2022, a total of 72 patients with advanced solid tumors were enrolled, including 32 patients with KRAS G12C mutation with non-small cell lung cancer with efficacy evaluation, with an objective response rate (ORR) of 56.
3% (18/32) and a disease control rate (DCR) of 90.
6% (29/32).

JAB-21822 has a good safety profile, with most treatment-related adverse events of grade
1 to 2.
Among the 72 patients, the incidence of diarrhea and vomiting was 5.
6% (4/72) and 6.
9% (5/72), respectively, and there were no secondary gastrointestinal adverse reactions
.

At present, JAB-21822 is simultaneously carrying out single-agent and combination clinical studies
in China, the United States and Europe.
These include monotherapy for patients with KRAS G12C mutations in non-small cell lung cancer, pancreatic ductal carcinoma, and colorectal cancer; Treatment of colorectal cancer patients in combination with EGFR monoclonal antibody; and in combination with the self-developed SHP2 inhibitor JAB-3312 for the treatment of
patients with non-small cell lung cancer.

About CDE breakthrough therapies

CDE's Breakthrough Therapy Designation (BTD) is designed to accelerate the clinical development
of new drugs with significant clinical advantages.
Breakthrough therapy drugs must be able to provide effective treatment for diseases for which there is no effective prevention or treatment
, or there is sufficient evidence of significant clinical superiority compared with existing treatments, and are seriously life-threatening or seriously affecting the quality of life.
According to CDE, breakthrough therapy designation provides CDE with an opportunity for more in-depth guidance and discussion on clinical trials and development strategies, as well as an opportunity
for future priority reviews.

About JAB-21822

JAB-21822 is a KRAS G12C inhibitor
independently developed by Jacobio.
Jacobio has initiated a number of phase I/II clinical trials in patients with advanced solid tumors in China, the United States and many European countries, including pivotal clinical trials in China for non-small cell lung cancer, as a first-line therapy monotherapy for STK11 co-mutant non-small cell lung cancer, and in combination with SHP2 inhibitor JAB-3312, anti-PD-1 monoclonal antibody and cetuximab
.