CBI-1214 Receives IND and FTD for Colorectal Cancer

The US FDA has approved an investigational new drug (IND) application and granted fast track designation (FTD) for CBI-1214, a T-cell engager being developed for the treatment of patients with colorectal cancer.¹

FTD is designed to facilitate the development and expedited review of drugs that treat serious conditions and fill an unmet medical need.

This approval allows Cartography Bio, the developer of CBI-1214, to initiate a phase 1 clinical trial for the drug.

“This IND approval allows us to advance CBI-1214, our novel T-cell engager, rapidly into clinical development,” said Dirk Nagorsen, MD, chief medical officer of Cartography, in a news release. “The [FTD] further validates the significant unmet need we are targeting in [colorectal cancer] and the potential impact of our approach. We look forward to expeditiously advancing our [p]hase 1 trial.”

CBI-1214 is a T-cell engager molecule that targets LY6G6D, an emerging and highly specific tumor antigen for treating patients with colorectal cancer. LY6G6D is expressed within the microsatellite stable and microsatellite instability-low subtypes of colorectal cancer. CBI-1214 has protein engineering features that are specifically designed to optimize anti-tumor activity.

Kevin Parker, CEO of Cartography Bio, said in a news release, “Receiving IND approval and [FTD] for CBI-1214 represent [2] important steps forward for Cartography, further validation of our ATLAS and SUMMIT discovery platforms, a tribute to the hard work and ingenuity of our entire team and crucial progress toward addressing the unmet needs of colorectal cancer patients.”

The ATLAS platform is a curated, fully integrated and proprietary set of single-cell RNA-based data and tissue repositories. ATLAS has 10 times the number of cells found in publicly available single-cell datasets.

The SUMMIT platform looks at multi-specific targeting to create synthetic targets.

REFERENCE

1.Cartography receives FDA investigational new drug (IND) approval and fast track designation for lead program CBI-1214 for colorectal cancer. News release. Cartography Biosciences. December 18, 2025. https://tinyurl.com/2kx2wtbf