Lunit announced a collaboration with Daiichi Sankyo to advance biomarker discovery and optimize translational research through integrating multiple AI-powered Lunit SCOPE digital pathology products across two of Daiichi Sanko’s oncology pipeline programs.

The collaboration announcement comes on the heels of FDA’s approval of Daiichi Sankyo’s Enhertu plus Perjeta for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer, marking the first new treatment approved in over a decade for the first-line treatment of HER2-positive breast cancer.

"Lunit SCOPE was built to unlock hidden insights from pathology slides––quantifying the tumor microenvironment, predicting molecular profiles and generating data-rich features to inform trial design," said Brandon Suh, CEO of Lunit. "SCOPE uIHC is now enabling the next generation of IHC-based biomarkers. By working with Daiichi Sankyo, we are embedding these capabilities into translational and clinical research, enabling faster biomarker discovery and more precise patient stratification. Ultimately, this means more efficient trials and better outcomes, where each patient has a greater chance of receiving the therapy that works best for them."

What are the details of the collaboration?

As part of the collaboration, Daiichi Sankyo will apply various Lunit SCOPE solutions, including SCOPE uIHC for quantitative Immunohistochemistry (IHC) analysis and SCOPE IO for immune phenotyping and spatial analysis, to explore novel biomarkers and to potentially enrich clinical trials or to potentially support precision patient stratification for select oncology pipeline programs.

Lunit SCOPE uIHC is an AI-powered digital pathology image analysis software designed to streamline IHC biomarker analysis across various cancer types and is trained on over 18 IHC stains spanning over 20 primary tumor origins, supporting CDx development for next-gen biomarkers, revealing drug target insights with high membrane and tumor specificity, and also drives translational research.²

The key features of Lunit SCOPE uIHC include:

• Continuous staining intensity quantification (0-100%) for each cell and subcellular components.
• Subcellular localization of target expression (membrane, cytoplasm, nucleus).
• Cell type identification, tumor cell, lymphocyte, and additional cell(s).
• Advanced biomarker analysis integrating quantitative intensity measurement, spatial profiling, and pattern recognition, applied individually or in combination to derive robust insights.
• Interactive visualizer enabling real-time intensity cut-off assessment.

Lunit SCOPE IO allows biopharma companies to identify tumor-agnostic, H&E-based immune biomarkers with precision and scale, accelerating biomarker development and enriching immunotherapy trials without additional stains or assays.³

It was trained on upwards of 50,000 whole-slide images and over 10 million cell annotations by hundreds of pathologists worldwide and analyzes tumor microenvironments by performing quantitative immune phenotyping and assessing the immune landscape.

The collaboration is also expected to include exploratory research projects and analyses across two oncology assets spanning multiple types of cancer, with the potential to inform future trial designs, biomarker strategies and clinical development plans.¹

Sources

1. Lunit Announces Collaboration with Daiichi Sankyo to Advance AI-Driven Biomarker Discovery and Translational Oncology Research Lunit Decmeber 15, 2025 https://www.prnewswire.com/news-releases/lunit-announces-collaboration-with-daiichi-sankyo-to-advance-ai-driven-biomarker-discovery-and-translational-oncology-research-302641994.html
2. Lunit SCOPE uIHC Information Lunit, Accessed December 16, 2025 https://www.lunit.io/en/precision-oncology/scope-ihc-suite/uihc-analysis/
3. Lunit SCOPE IO Information Lunit, Accessed December 16, 2025 https://www.lunit.io/en/precision-oncology/scope-io/