NEW YORK – Jacobio Pharma began a pivotal trial in China of its KRAS inhibitor glecirasib in patients with KRAS G12C-mutant advanced or metastatic pancreatic cancer.
On Monday, China's National Medical Products Administration (NMPA) granted breakthrough therapy designation to glecirasib as a potential treatment for KRAS G12C-mutant pancreatic cancer. Breakthrough therapy designations allow firms access to intensive guidance and discussion with the NMPA's Center for Drug Evaluation and the opportunity to seek priority review for regulatory applications. In the pivotal trial underway, Jacobio is studying the drug in pancreatic cancer patients who have progressed after front-line standard-of-care treatment.
Jacobio is also studying glecirasib, previously known as JAB-21822, in non-small cell lung cancer patients harboring KRAS G12C and STK11 mutations, and in combination with Eli Lilly's Erbitux (cetuximab) in KRAS G12C-mutant colorectal cancer patients.
The firm also has an ongoing Phase I/II trial in the US of glecirasib with or without Erbitux in patients with advanced KRAS G12C-mutated solid tumors.
Beijing-based Jacobio is developing several other therapies targeting the KRAS pathway, including a SHP2 inhibitor, a KRAS-multi inhibitor, an Aurora kinase A inhibitor, along with preclinical programs targeting LIF and KRAS G12D.