Jacobio Pharma receives breakthrough therapy designation for glecirasib

2023-08-08

突破性疗法优先审批临床结果

Jacobio Pharma receives breakthrough therapy designation for glecirasib

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来源: Pharmaceutical Technology

Glecirasib is intended for the treatment of pancreatic cancer patients with the KRAS G12C mutation. Credit: Nemes Laszlo/Shutterstock.com.

Jacobio Pharma has received breakthrough therapy designation (BTD) for glecirasib to treat pancreatic cancer patients with the KRAS G12C mutation.

The company’s in-house KRAS G12C inhibitor KRAS G12C inhibitor received the designation from the Center for Drug Evaluation of China’s National Medical Products Administration.

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The BTD has been granted based on the results from an ongoing pivotal, multi-centre, single-arm, open-label study that assessed the safety and efficacy of the single agent glecirasib.

Patients with KRAS G12C-mutated locally advanced or metastatic pancreatic cancer who progressed on frontline standard care treatment were enrolled in the trial.

In December 2022, glecirasib received the first BTD for treating advanced or metastatic non-small cell lung cancer (NSCLC) patients with the KRAS G12C mutation.

Jacobio is also currently conducting a pivotal Phase I/II monotherapy study in China evaluating glecirasib in STK11 [a germline mutation] co-mutated NSCLC patients in the front-line setting.

Combination therapy trials of glecirasib with SHP2 inhibitor SHP2 inhibitor JAB-3312 to treat NSCLC and with Cetuximab for colorectal cancer are also being carried out in the country.

Other Phase I/II clinical trials of glecirasib are ongoing in Europe and the US for treating patients with advanced solid tumours harbouring the KRAS G12C mutation.