Jacobio Pharma (HKG: 1167), a China-based biopharmaceutical company, has announced that it has received Orphan Drug Designation (ODD) from the European Medicine Agency (EMA) for its KRAS G12C inhibitor, glecirasib, for the treatment of pancreatic cancer. This designation follows previous awards for glecirasib, including ODD in the US and Breakthrough Therapy Designation (BTD) in China for the same indication.
Glecirasib, developed in-house by Jacobio, is currently the subject of multiple studies across China, the United States, and Europe for various cancer types, including non-small cell lung cancer (NSCLC), colorectal cancer, and pancreatic cancer. The latest clinical data for glecirasib in second-line and above settings for KRAS G12C mutant pancreatic cancer have shown promising results, with a confirmed objective response rate of 41.9% (13 out of 31 patients), a disease control rate of 93.5% (29 out of 31 patients), a median progression-free survival (mPFS) of 5.6 months, and a median overall survival (mOS) of 10.7 months.
These positive clinical outcomes position glecirasib as a potential new treatment option for patients with pancreatic cancer, a disease with limited therapeutic options, and highlight Jacobio’s commitment to advancing targeted therapies for hard-to-treat cancers.- Flcube.com