HHS Notice: NCI Seeks Partners for Novel Anti-CE1 Antibodies in Liver Cancer Treatment

What this means for your practice

For telehealth brands, medspas, dental practices, and chiropractic offices, this notice primarily offers insight into the broader landscape of biomedical innovation and future therapeutic trends. While it does not directly impact current regulatory compliance or operational protocols for these specialties, it highlights the ongoing federal investment in developing advanced therapeutic options, particularly in oncology. Operators in fields adjacent to oncology, or those considering future expansion into integrated care models or clinical research partnerships, may find value in tracking such developments. Understanding the progression of novel treatments like these anti-CE1 antibodies can inform long-term strategic planning, particularly concerning future referral pathways for patients with complex conditions like hepatocellular carcinoma, or potential advancements in supportive care that might eventually integrate with telehealth services. It also underscores the potential for future M&A activities or strategic partnerships in the biopharmaceutical space for larger healthcare organizations, signaling areas of active research and development that could shape the future of patient care.

Washington, D.C. – The Department of Health and Human Services (HHS) has announced through the National Institutes of Health (NIH) that the National Cancer Institute (NCI) is actively seeking research co-development partners and/or licensees. The focus of this initiative is a novel collection of human anti-CE1 antibodies designed for the treatment of liver cancer.

The Urgent Need in Liver Cancer Treatment

Liver cancer represents a significant global health challenge, ranking as the sixth most common cancer and the third leading cause of cancer-related death worldwide. Hepatocellular carcinoma (HCC) is the most prevalent form of liver cancer in adults, characterized by its aggressive nature and increasing incidence and mortality rates globally. Current methods for early detection, surveillance, and treatment of HCC are widely recognized as suboptimal. This inadequacy is largely attributed to the complex etiologies of the disease, underscoring a critical need for more effective therapeutic interventions.

Discovery of the Anti-CE1 Antibodies

NIH investigators previously identified a novel viral peptide antigen, termed CE1. This peptide, associated with the rhinovirus and enterovirus families (NIH Reference Number: E-023-2024), has demonstrated a dominant humoral response linked to a reduced incidence and mortality of HCC. Building upon this discovery, NCI inventors utilized phage display technology from a human single-chain fragment variable (scFv) phage library to isolate two distinct human antibodies: B9 and B10, both specifically targeting the CE1 viral peptide.

These newly constructed human anti-CE1 B9 and B10 antibodies have shown promising results in pre-clinical studies. They exhibited specific binding to liver cancer cell lines and clinical tumor tissues. Crucially, in both in vitro and in vivo models, these antibodies demonstrated the ability to inhibit HCC tumor growth by inducing NK cell-mediated antibody-dependent cellular cytotoxicity. This mechanism suggests a potent anti-tumor effect.

Potential Therapeutic Applications and Commercial Advantages

The anti-CE1 antibodies (B9 and B10) are considered to have significant potential as liver cancer therapeutics. They can be utilized either as standalone treatments or as the targeting domain within immunoconjugates, opening various avenues for drug development. The NCI is actively seeking collaborators to advance these pre-clinical stage assets through further development.

Potential Commercial Applications include: * Development of new cancer therapeutics, particularly those capable of overcoming PD-1/PD-L1 checkpoint blockade resistance. * Creation of alternative or combination immunotherapies specifically for checkpoint-refractory tumors. * Preclinical screening platforms for evaluating such alternative or combination immunotherapies. * Evaluation of cancer therapeutic strategies for cancers exhibiting defective antigen processing/presentation or loss of MHC-I expression. * Development of companion models for comparing checkpoint-resistant MC38 B2m KO tumors against checkpoint-responsive wild-type MC38 tumors.

Competitive Advantages highlighted by the NCI include: * The antibodies uniquely model a clinically relevant checkpoint-resistance mechanism. * They leverage the well-established and regulatorily de-risked MC38 colon cancer model. * The model is unique in permitting the interrogation of abrogated responses to anti-PD-1 and anti-PD-L1 treatment.

Licensing Opportunity and Contact Information

This notice is issued in accordance with 37 CFR 404.4, which outlines the Authority to grant licenses for government-owned inventions. The provisional patent for these antibodies was filed on August 8, 2025 (NIH Reference Number: E-021-2025). The development stage is currently pre-clinical, with in vivo validation already demonstrated.

Parties interested in exploring this licensing or co-development opportunity are encouraged to direct their inquiries to:

Michael Pollack, Ph.D. Unit Supervisor, NCI, Technology Transfer Center Email: [email protected] Phone: 240-276-5519

The notice was dated August 7, 2026, and signed by Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute.

Key Facts

| Detail | Value | |---|---| | Issuing Agency | National Institutes of Health, HHS (National Cancer Institute) | | Action | Notice seeking research co-development partners and/or licensees | | Product Type | Therapeutic (Human anti-CE1 antibodies B9 and B10) | | Therapeutic Area(s) | Gastroenterology, Oncology (Liver Cancer/Hepatocellular Carcinoma) | | Development Stage | Pre-clinical (in vivo validation) | | Patent Status | Provisional Patent filed on August 8, 2025 (NIH Ref: E-021-2025) |

Frequently Asked Questions

What is the NCI offering for licensing?

The NCI is offering a collection of anti-CE1 antibodies (B9 and B10) that target a novel viral peptide, CE1, for the treatment of liver cancer, specifically hepatocellular carcinoma (HCC).

What stage of development are these antibodies in?

These anti-CE1 antibodies are currently in the pre-clinical development stage, having undergone in vivo validation.

What are the potential uses for these antibodies?

They have potential as liver cancer therapeutics, either on their own or as the targeting domain of an immunoconjugate. They are also relevant for developing cancer therapeutics that overcome checkpoint blockade resistance, alternative immunotherapies, and for preclinical screening.

Who should contact NCI regarding this opportunity?

The NCI seeks research co-development partners and/or licensees interested in advancing these anti-CE1 antibodies for liver cancer treatment.

What regulation authorizes NCI to offer this license?

This Notice is in accordance with 37 CFR 404.4, which grants the authority to license government-owned inventions.

Source: HHS — Notice: Government Owned Invention Available for License: Human Antibodies Targeting Beneficial Viral Peptide in Liver Cancer · 2026-08-12