Nucleai to Showcase Expanded Suite of ADC Biomarker Scoring Solutions at ASCO 2025

• Nucleai’s industry-leading solutions for AI-driven spatial analysis and quantitative biomarker scoring will be on display for biopharma companies exploring a biomarker-driven approach for their ADC trials
• Expanded ADC suite includes optical density (OD)-based quantitative biomarker scoring to analyze subcellular expression of target proteins and spatial proximity analyses to model a drug’s potential bystander effect, both of which could be correlated to patient response

Nucleai, an AI-powered spatial biomarker and diagnostics company, will showcase its expanded suite of solutions for antibody-drug conjugate (ADC) clinical trials at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held this week from May 30-June 3 in Chicago, IL. Recent studies have demonstrated that AI-powered computational pathology and spatial biomarkers can predict ADC treatment response more accurately than standard pathological scores, enabling ADC developers to derisk their drug development programs by designing biomarker-informed clinical trials. Nucleai’s commercially available ADC suite of solutions unlocks unparalleled granularity for ADC developers, including high sensitivity for low levels of biomarker expression as well as detecting subcellular protein expression.

At ASCO, Nucleai will demo their OD-based quantitative biomarker scoring solution, which solves the challenges of manual visual scoring of immunohistochemistry (IHC) images by pathologists, which could lead to inconsistent results and an incomplete understanding of drug efficacy. The analysis suite also includes spatial biomarker scoring methods to model a drug’s potential bystander effect, with implications for patient stratification and trial design. In addition to these applications, biopharma partners developing ADC and immunotherapy combination therapy strategies can evaluate tumor immunogenicity and identify specific immune cell subsets in the tumor microenvironment using Nucleai’s multimodal capabilities, which combine IHC data with hematoxylin and eosin (H&E) stained biopsy slides.

Demand has continued to rise for AI-powered quantitative biomarker scoring, especially for ADC development, where the exact mechanism of action (MOA), treatment response, and resistance mechanisms have not been fully established. For example, in some studies, researchers have concluded that high levels of protein expression on the surface of tumor cells are correlated to patient outcomes, but in other studies, treatment response is correlated to higher expression of the protein in the cell’s cytoplasm. On the other hand, in some indications, there is no clear correlation between protein expression levels in the patient and their response to the drug. In addition to supporting drug development, clinicians are also in need of better biomarkers to help guide the sequence of treatment in indications like hormone receptor (HR)-positive breast cancer, where multiple ADCs with similar cytotoxic payloads have been approved in recent years.

Nucleai, which has pioneered the use of AI for spatial biomarker analysis, has been working with leading ADC developers to evaluate their trials with this expanded suite of capabilities. As an add-on to these capabilities, Nucleai will also unveil an AI-driven analysis studio that enables easier extraction of actionable MOA and biomarker insights from complex computational pathology and spatial biology data. With this advancement, biopharma partners now have faster access to actionable insights, which can be applied to clinical trials and companion diagnostics in the future.

The expanded ADC suite also includes a novel spatial proteomics dataset with over 200 tumor and normal samples, across 30 biomarkers and 3 indications to profile ADCs, bispecific antibody targets, the tumor immune microenvironment, and for credentialing potential combination therapy strategies.

"Biomarker exploration often stops at identifying correlations, but the promise of AI-based spatial biomarkers and diagnostics is to move beyond this limited understanding," said Avi Veidman, CEO and co-founder of Nucleai. "With this expanded suite of ADC solutions, researchers can shift from passive observation to active investigation with an interactive interface, helping to bridge the gap from correlation to causality. This approach enables our biopharma partners to accelerate development by deriving clinically meaningful insights from complex data."

Next week at ASCO (booth #IH02), the Nucleai team will be sharing specific applications of the ADC solutions suite with demos that cover target identification, credentialing of bispecific targets and combination strategies, OD-based quantitative biomarker scoring, and spatial scoring to model a drug’s potential bystander effect. The demos will show how Nucleai is reducing the burden on bioinformatics and pathology teams by providing intuitive tools for real-time interaction with data.

Poster Presentation: Biomarkers of Immunotherapy Response in Melanoma

Also at ASCO, Nucleai’s AI-powered spatial biomarker technology combined with Lunaphore (a Bio-Techne brand)���s high-throughput, hyperplex COMET™ platform will be featured in a poster presentation in collaboration with Dr. Paolo A. Ascierto, Director of the Melanoma and Cancer Immunotherapy Unit at the National Cancer Institute in Naples.

The poster, titled “Application of a novel multiplex imaging-based immunotherapy panel and AI-powered analysis solution for predictive spatial biomarker identification on immunotherapy-treated melanoma patients,” will be presented on Sunday, June 1 from 9:00 AM – 12:00 PM CDT in Hall A - Posters and Exhibits.

For more information, visit nucleai.ai/asco2025.

About Nucleai

Nucleai is a leading AI-powered spatial biomarker and diagnostics company, advancing drug development and clinical decision-making through the analysis of cellular interactions and spatial relationships within tissue samples. By adapting geospatial analytical methods initially developed for military purposes, Nucleai applies these capabilities to biospatial analysis in oncology. This enables precise mapping of cellular interactions within tissue samples, which is needed for developing complex therapeutics such as bispecific antibodies and antibody-drug conjugates (ADCs). Nucleai’s approach mitigates risks in drug development by improving the accuracy of biomarker identification, optimizing patient selection, and ultimately increasing the probability of clinical success. The company is backed by investors including Section 32, Sanofi Ventures, M Ventures, Vertex Ventures, and Debiopharm Innovation Fund. For more information, visit www.nucleai.ai.

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