Federal Register #2026-16441

Licensing and Co-Development Opportunity for Cancer Treatment and Diagnostic Technologies from NCI

The National Cancer Institute (NCI), part of the Department of Health and Human Services (HHS), is offering licensing and co-development opportunities for innovative cancer treatment and diagnostic technologies. - Government Buyer: - Department of Health and Human Services (HHS) - National Institutes of Health (NIH) - National Cancer Institute (NCI) - Technologies Available for License and Collaboration: - Drug-Regulatable, Inducible Membrane-Bound Interleukin 12 (DRIM-IL-12) Platform - Part Number: E2172023 - Enhances anti-tumor efficacy and safety in adoptive cell therapy (engineered T-cells: CAR, TCR, TILs) - Features tightly regulated, drug-responsive membrane-bound IL-12 cytokine - DNA Methylation-Based Cancer Diagnostic Platform - Part Number: E10520230 - Enables accurate classification of CNS, kidney, and hematopoietic tumors - Improves diagnostic confidence and clinical decision-making - Includes software tool (MethylScape Analysis) for tumor classification - Monoclonal Antibody (RO4) Targeting Mesothelin - Reacts with juxta-membrane region of mesothelin - Intended for treatment of mesothelin-expressing cancers - Notable Requirements: - Technologies are at pre-clinical or prototype stage - Opportunity includes licensing and co-development for commercial applications - Potential for external validation, assay standardization, integration into clinical workflows, and expansion to additional tumor types - No specific OEMs or commercial vendors are named; inventions are government-owned and available for commercial development.

Description

This technology is a DNA methylation-based diagnostic platform designed to improve the accuracy and consistency of cancer classification, particularly for tumors of the central nervous system, kidney, and hematopoietic system. It identifies disease-specific methylation signatures to reduce interobserver variability and enhance diagnostic confidence. The platform includes a central nervous system classifier built from 16,567 methylation profiles, organizing tumors into 22 families and 133 diagnostic classes, including 21 new methylation classes. Validation across multiple cohorts demonstrated robust performance, influencing final diagnosis in 74.4% of cases. The classifier is deployed as a user-facing software tool, MethylScape Analysis, to streamline classification workflows.

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