Notice2026-03338
Government Owned Inventions Available for License: Novel Human Immunogenic Epitopes of the Human Endogenous Retrovirus ERVMER34-1
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 20, 2026
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Cancer Institute (NCI), an institute/center of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the license opportunity for the invention listed below, which is owned by an agency of the U.S. Government and is available to achieve expeditious commercialization of results of federally-funded research and development.
Full Text
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<title>Federal Register, Volume 91 Issue 34 (Friday, February 20, 2026)</title>
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[Federal Register Volume 91, Number 34 (Friday, February 20, 2026)]
[Notices]
[Pages 8260-8261]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03338]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government Owned Inventions Available for License: Novel Human
Immunogenic Epitopes of the Human Endogenous Retrovirus ERVMER34-1
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The National Cancer Institute (NCI), an institute/center of
the National Institutes of Health (NIH), Department of Health and Human
Services (HHS), is giving notice of the license opportunity for the
invention listed below, which is owned by an agency of the U.S.
Government and is available to achieve expeditious commercialization of
results of federally-funded research and development.
FOR FURTHER INFORMATION CONTACT: Inquiries related to this license
opportunity should be directed to: Michael Pollack, Ph.D., Unit
Supervisor, NCI, Technology Transfer Center, Email:
<a href="/cdn-cgi/l/email-protection#c9a4a0aaa1a8aca5e7b9a6a5a5a8aaa289a7a0a1e7aea6bf"><span class="__cf_email__" data-cfemail="dbb6b2b8b3babeb7f5abb4b7b7bab8b09bb5b2b3f5bcb4ad">[email protected]</span></a> or Phone: 240-276-5519.
SUPPLEMENTARY INFORMATION: The NCI seeks research co-development
partners and/or licensees for the clinical translation of novel
peptide-based therapeutic cancer vaccines derived from ERVMER34-1, a
human endogenous retrovirus (HERV) antigen, offering a unique
opportunity to address a significant unmet need in the treatment of
various carcinomas.
HERVs, remnants of ancient retroviral germline infections that
comprise ~8% of the human genome, represent a promising yet
underexplored frontier in targeted cancer therapy. Although typically
epigenetically silenced in normal adult tissues, select HERV
components, including RNAs and envelope proteins, are frequently
overexpressed in various carcinomas due to epigenetic dysregulation--a
hallmark of cancer. The challenge lies in identifying specific, highly
immunogenic HERV targets that elicit potent anti-tumor immune responses
without triggering autoimmunity. Addressing this need is critical to
advancing broadly applicable cancer immunotherapies.
Inventors at the NCI have developed and characterized a novel
cancer immunotherapy platform targeting ERVMER34-1, a specific HERV
envelope protein that is highly expressed across multiple human
carcinomas while exhibiting minimal expression in normal tissues. Using
transcriptomic and proteomic datasets, the team confirmed the tumor-
selective expression profile of ERVMER34-1. To improve safety and
specificity, they engineered an artificial antigen-presenting cell line
to express the full-length ERVMER34-1 protein, HLA-A2 and CD80 to
facilitate efficient priming and expansion of ERVMER34-1-reactive CD8+
T cells. To therapeutically target ERVMER34-1, they modified the
ERVMER34-1 protein by removing the signal peptide, cleavage site,
predicted immunosuppressive domain, transmembrane domain and a 170-
amino acid region homologous to human proteins. These modifications
prevent surface trafficking, antigen shedding, immune dampening, and
off-target reactivity. This modified sequence was incorporated into a
recombinant adenoviral vector as a therapeutic cancer vaccine. In
preclinical murine models (e.g., MC38 colon cancer, EMT6 breast
cancer), vaccination with this construct alone or in combination with
immune checkpoint blockade or an IL-15 superagonist elicited robust,
multifunctional CD4\+\ and CD8\+\ T cell responses. Those enhanced T
cell responses induced tumor clearance, increased intratumoral
lymphocyte infiltration, broadened neoantigen spreading and prolonged
tumor control. ERVMER34-1-reactive T cells could be expanded from both
healthy donor and cancer patient Peripheral Blood Mononuclear Cells
(PBMCs) and demonstrated specific cytolytic activity against ERVMER34-
1\+\ human carcinoma cell lines in vitro. To support peptide-based
approaches, researchers
[[Page 8261]]
developed an overlapping 15-mer peptide library spanning the modified
ERVMER34-1 protein sequence. These peptides elicited strong,
polyfunctional T cell responses in vitro--including both CD4\+\ and
HLA-A2-restricted CD8\+\ T cell activation, enabling precise epitope
mapping and facilitating future peptide vaccine design and adoptive T
cell receptor (TCR)-based therapies.
NIH Reference Number: E-159-2019-0.
Therapeutic Area(s): Oncology/Immunology.
Related Invention: E-056-2023-0.
Potential Commercial Applications:
<bullet> Peptide-based therapeutic cancer vaccines.
<bullet> Adenoviral vector-based therapeutic cancer vaccines.
<bullet> Liposome- or nanoparticle-formulated therapeutic cancer
vaccines.
<bullet> Artificial Antigen-Presenting Cell platforms expressing
ERVMER34-1 with HLA-A2 and CD80 to expand antigen-specific T cells for
adoptive cell therapies.
<bullet> Adoptive T cell therapies using ERVMER34-1-specific TCRs
isolated from PBMCs or engineered T cells redirected against shared
HERV antigens.
<bullet> Combination immunotherapies pairing the ERVMER34-1 vaccine
with checkpoint inhibitors and/or epigenetic modifiers to boost
response breadth and tumor infiltration.
<bullet> Cytokine or immuno-cytokine-enhanced combination regimens
incorporating immune-oncology agents to amplify tumor-specific T cell
activation.
<bullet> Companion diagnostic tools to identify ERVMER34-1-
expressing tumors for patient selection and treatment stratification.
Competitive Advantages:
<bullet> Broad tumor coverage across ~62% of carcinomas.
<bullet> Minimal expression in normal tissues reduces toxicity risk
and expands market potential.
<bullet> Engineered antigen design in vaccine eliminates
immunosuppressive and off-target domains, improving safety and
therapeutic precision.
<bullet> Elicits potent, multifunctional T cell responses with
cytokine production and broad epitope recognition, enhancing anti-tumor
efficacy.
<bullet> Selectively clears tumor cells based on ERVMER34-1
expression, enabling precise targeting across variable antigen levels.
<bullet> Demonstrates remarkable synergistic efficacy with immune
checkpoint inhibitors, achieving ~89% tumor clearance in established
large tumors in mouse models.
<bullet> Exhibits synergistic interaction with cytokine agonists
such as N-803 (Anktiva), significantly enhancing neoepitope-reactive T
cell responses and improving tumor control in combination therapies.
<bullet> Potential for use in combination with epigenetic
modulators to enhance expression of targeted antigen in human
carcinomas.
Patent Applications:
<bullet> Australia National Stage 2021210915; filed on 2022-08-18;
Status: Pending.
<bullet> Canada National Stage 3165251; filed on 2022-07-19;
Status: Pending.
<bullet> European Patent National Stage 21705769.4; filed on 2022-
08-18; Status: Pending.
<bullet> US National Stage 17/793,753; filed on 2022-07-19; Status:
Pending.
<bullet> Hong Kong: European patent (EP) 62023070659.5; filed on
2023-03-27; Status: Pending.
Development Stage: Pre-clinical (in vivo).
Collaboration Opportunity: Researchers at the NCI seek licensing
and/or co-development research collaborations for the clinical
translation of novel peptide-based therapeutic cancer vaccines derived
from ERVMER34-1, a human endogenous retrovirus (HERV) antigen, offering
a unique opportunity to address a significant unmet need in the
treatment of various carcinomas.
Publications:
<bullet> Maldonado MDM, et al. Combination of a therapeutic cancer
vaccine targeting the endogenous retroviral envelope protein ERVMER34-1
with immune-oncology agents facilitates expansion of neoepitope-
specific T cells and promotes tumor control (PMID: 40360436).
<bullet> Gracia-Hernandez M, et al. Combination Therapy Approaches
to Enhance the Efficacy of ERV-Targeting Vaccines in Cancer (PMID:
40387511).
Dated: February 17, 2026.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2026-03338 Filed 2-19-26; 8:45 am]
BILLING CODE 4140-01-P
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