GeNeuro Wins European Patent for GNK-301, an Anti-HERV K Antibody Targeting ALS
核心洞察
GeNeuro, Inc. (搜索), a subsidiary of NRx Pharmaceuticals, has been awarded European Patent EP 3 570 878 B1 covering the anti-HERV K Envelope antibody GNK-301 for ALS.
The patent rests on the finding that the HERV K Envelope protein appears in the spinal fluid of more than 75% of people with ALS and is highly neurotoxic.
GNK-301 was developed with the US National Institute of Neurological Disorders and Stroke under a Cooperative Research and Development Agreement and is now in cGMP manufacture.
GeNeuro, Inc. (搜索), a subsidiary of NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), announced on Sept. 14, 2026 the award of European Patent EP 3 570 878 B1, entitled "Anti HERV K Envelope Antibody and Uses Thereof," covering the company's novel monoclonal antibody GNK-301 for amyotrophic lateral sclerosis (搜索) (ALS). The European grant joins two previously issued US patents (10,723,787 and 10,981,977) covering the same invention.
A Retroviral Hypothesis for ALS
The patent portfolio is built on the discovery that the envelope protein of Human Endogenous Retrovirus K (HERV K), known as K Env, is found in the spinal fluid of more than 75% of people with ALS. According to the company, K Env is highly neurotoxic and has been shown to produce the neurodegenerative findings of ALS in laboratory animals and in human motor neuron cell culture — the cells damaged by the disease.
HERVs are remnants of viruses that infected primates between 2 and 5 million years ago and are now thought to have played a role in human disease. The K Env protein is coded in the "dark genome" present in all people, and the company's working hypothesis is that ALS may be caused by its reactivation.
As described in the patents, GNK-301 has been shown to prevent the neurotoxic effects of K Env in nonclinical subjects and in human motor neuron cells.
Development Under a NIH CRADA
The discovery was made by a team of scientists from Geneuro SA (Lyon, France) and the US National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health, working under a Cooperative Research and Development Agreement (CRADA) and a subsequent patent agreement. The patents are jointly owned by GeNeuro and the US Department of Health and Human Services.
The assets of the former Geneuro SA were awarded to GeNeuro, Inc. (搜索) (Miami, FL) by the Courts of Switzerland in June 2026. GeNeuro has since initiated manufacture of GNK-301 under Good Manufacturing Practices (cGMP) and anticipates initiating human Phase 1 trials in patients with ALS in the second half of 2027 in the US and Europe. A separate company description in the announcement states that GNK-301 is anticipated to enter Phase 1 human trials in the second half of 2026.
Prior Clinical Experience With Anti-HERV Antibodies
Geneuro SA previously conducted five human trials of a related antibody, Temelimab, which targets the envelope protein of HERV W, in more than 400 human participants with multiple sclerosis (搜索), type 1 diabetes (搜索), or symptoms of long Covid (搜索). No Serious Adverse Events were reported. Temelimab was shown to cross the blood-brain barrier and to achieve a statistically significant reduction in neurodegeneration, as measured by "Black Holes" on magnetic resonance imaging, with a corresponding reduction in brain shrinkage.
The company believes these results support the potential for anti-HERV envelope antibodies to achieve clinically meaningful effects in patients with HERV-mediated neurodegenerative diseases. Temelimab has reached Phase 2 in Europe, with completed trials demonstrating statistically significant reductions in neurodegeneration in multiple sclerosis (搜索) and decreased islet cell destruction in type 1 diabetes (搜索).
The newly issued European patent adds to a portfolio of more than 25 issued and pending patents owned by GeNeuro related to the effects of HERVs and to methods of diagnosing and mitigating those effects.
Grant Funding and Scientific Convening
In August 2026, GeNeuro, in partnership with NINDS, was selected in the first round of the ALS grant competition of the Congressionally Directed Medical Research Program (CDMRP) for potential awards in Therapeutic Development and Biomarker Development, and is preparing its final bid submission.
The first annual conference on "HERVs and Humanity" is being held at the Princeton Institute for Advanced Study, bringing together an international group of clinicians and molecular biologists to prioritize research objectives and clinical priorities in the field, with portions of the conference simulcast.
"ALS is possibly the most devastating diseases one can contract, with a life expectancy of two to five years," said Dr. Jonathan Javitt, the company's CEO. "The opportunity to partner with the NIH and leading experts across the globe around a biomarker-targeted, potentially disease-modifying drug has the potential to forever change the course of this terrible disease."
GeNeuro describes its asset base as including the products of more than $180 million in funded research on HERV-targeted drugs for ALS, multiple sclerosis (搜索), type 1 diabetes (搜索), and schizophrenia (搜索). NRx Pharmaceuticals, the parent company, is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD.