Cartography receives FDA IND approval and Fast Track status for CBI-1214 in colorectal cancer
Friday, December 19, 2025
Cartography Biosciences has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for CBI-1214, the company’s lead programme. The approval allows Cartography to begin a Phase I clinical trial of CBI-1214, a T-cell engager being developed for the treatment of colorectal cancer.
Alongside the IND approval, the FDA has granted Fast Track designation to CBI-1214. This designation is intended to support the development and faster review of treatments for serious conditions with unmet medical needs. The combined milestones highlight the potential of CBI-1214 and the need for new treatment options in colorectal cancer. Cartography plans to start the Phase I trial in the first quarter of 2026.
CBI-1214 is designed to target LY6G6D, a tumour antigen that is highly specific to colorectal cancer and shows minimal expression in healthy cells. The target is mainly found in microsatellite stable and microsatellite instability-low subtypes of colorectal cancer, which account for most patients and represent a significant area of unmet need.
The therapy incorporates specific protein engineering features aimed at enhancing anti-tumour activity, supporting its potential as a targeted treatment option for patients with colorectal cancer.
Source: businesswire.com
