Cartography Receives FDA Investigational New Drug (IND) Approval and Fast Track Designation for Lead Program CBI-1214 for Colorectal Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cartography Biosciences, Inc., a biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for its lead program, CBI-1214. This approval enables Cartography Bio to initiate a Phase I clinical trial for CBI-1214, a T-cell engager being developed for the treatment of colorectal cancer (CRC).

In addition to the IND approval, Cartography Bio also announced that CBI-1214 has been granted Fast Track designation by the FDA. This status is designed to facilitate the development and expedited review of drugs that treat serious conditions and fill an unmet medical need, underscoring the potential of CBI-1214 and the urgent, unmet need among patients with CRC. These milestones mark the next steps forward in bringing a potential new, highly specific, tumor antigen therapy to patients with CRC. Cartography anticipates initiating its Phase I clinical trial in the first quarter of 2026.

Kevin Parker, Cartography Bio CEO, said, “Receiving IND approval and Fast Track designation for CBI-1214 represent two 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.”

Dirk Nagorsen, MD, Cartography’s CMO, added, “This IND approval allows us to advance CBI-1214, our novel T-cell engager, rapidly into clinical development. The Fast Track designation further validates the significant unmet need we are targeting in CRC and the potential impact of our approach. We look forward to expeditiously advancing our Phase I trial.”

CBI-1214, Cartography’s lead program, is a T-cell engager molecule that targets LY6G6D, an emerging and highly specific tumor antigen for treating CRC patients. The target, which has minimal expression on healthy cells, is uniquely expressed within the microsatellite stable (MSS) and microsatellite instability-low (MSI-L) subtypes of CRC, which represent the vast majority of CRC patients and remains a major area of unmet medical need. CBI-1214 has protein engineering features that are specifically designed to optimize anti-tumor activity.

About Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer diagnosed in both men and women in the United States, and the second leading cause of cancer-related deaths globally. According to the American Cancer Society, an estimated 153,020 new cases of colorectal cancer are diagnosed annually in the U.S., leading to approximately 52,550 deaths. Despite advances in treatment, many patients face significant challenges, particularly in advanced stages, highlighting the urgent need for innovative and more effective therapeutic options.

About Cartography Biosciences

Cartography Biosciences is advancing a differentiated oncology pipeline of antibody-based therapies designed to target tumors more precisely than existing therapeutics. Cartography’s ATLAS and SUMMIT drug discovery platforms are powered by an industry-leading, fully integrated dataset spanning hundreds of thousands of cell states across the healthy body and large-scale profiling of individual cells from patient tumors. By leveraging petabytes of proprietary data, along with insights from machine learning and AI, Cartography is discovering antibodies against highly specific targets and target pairs to build a pipeline of molecules with the greatest patient impact. Cartography’s lead program CBI-1214 is a T-cell engager for CRC. To learn more about Cartography and our mission to treat every patient with cancer, visit cartography.bio and follow us on LinkedIn and X @cartographybio.

Media:
Ashlea Kosikowski, 1AB
Ashlea@1abmedia.com