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  • ||||||||||  temelimab (GNbAC1) / GeNeuro, Rituxan (rituximab) / Roche
    Journal:  HERV Dysregulation in a Case of Myalgic Encephalomyelitis and Multiple Sclerosis Responsive to Rituximab. (Pubmed Central) -  May 28, 2025   
    Limitations of the study include sub-optimal frequency of magnetic resonance imaging to monitor lesion progression, and similarly for reassessment of HERV profiles after rituximab. Overall, the coincidence of HERV alterations and the impactful response to rituximab presents the possibility of additional, more specific, therapeutic targets encoded by other HERV elements yet to be discovered.
  • ||||||||||  GNK301 / GeNeuro
    GNK-301 a therapeutic antibody neutralizing HERV-K ENV for precision medicine in sporadic ALS (Poster Hall at the Palais de Congres Montreal; 517b/c) -  Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_526;    
    Combining our therapeutic and diagnostic tools for clinical trials in sporadic ALS with principles of precision medicine is expected to allow identifying patients who could benefit from this targeted treatment and to avoid the now debated heterogeneity of ALS subtypes. However, this may also reinforce the need for using such diagnostic tests for an early detection and treatment in patients whose clinical deficits may not be reversible after a certain period and an extended loss of motoneurons.
  • ||||||||||  temelimab (GNbAC1) / GeNeuro
    Review, Journal:  Mycobacterium paratuberculosis: A HERV Turn-On for Autoimmunity, Neurodegeneration, and Cancer? (Pubmed Central) -  Sep 29, 2024   
    This article further points to MAP infection as a contributor to autoimmunity, neurodegenerative disease and cancer via the un-silencing of HERV. We examine the link between the ever-increasing number of MAP-associated diseases and the MAP/HERV intersection with these diverse medical conditions, and propose treatment opportunities based upon this association.
  • ||||||||||  temelimab (GNbAC1) / GeNeuro, Paxlovid (nirmatrelvir and ritonavir) / Pfizer
    Review, Journal:  Etiopathogenic theories about long COVID. (Pubmed Central) -  Jul 3, 2023   
    Recruiting --> Active, not recruiting The main etiopathogenic theories of long coronavirus disease (COVID) are listed and a conjunction of them is carried out with the objective of deciphering the pathophysiology of the entity, finally the main lines of treatment existing in real life are discussed (Paxlovid, use of antibiotics in dysbiosis, triple anticoagulant therapy, temelimab).
  • ||||||||||  temelimab (GNbAC1) / GeNeuro
    Journal:  CancerHERVdb: Human Endogenous Retrovirus (HERV) Expression Database for Human Cancer Accelerates Studies of the Retrovirome and Predictions for HERV-Based Therapies. (Pubmed Central) -  Jul 3, 2023   
    In our report, we provide examples of potential uses of the CancerHERVdb, such as identification of cancers suitable for off-target treatment with the multiple sclerosis-associated retrovirus (MSRV)-Env-targeting antibody GNbAC1 (now named temelimab) currently in phase 2b clinical trials for multiple sclerosis or the discovery of cancers overexpressing HERV-H long terminal repeat-associating 2 (HHLA2), a newly emerging immune checkpoint...Therefore, the CancerHERVdb database can aid in the identification of prognostic and risk markers, drivers of cancer, tumor-specific targets, multicancer spanning signals, and targets for immune therapies. Consequently, the CancerHERVdb database is of direct relevance for clinical as well as basic research.
  • ||||||||||  temelimab (GNbAC1) / GeNeuro
    Trial completion date, Trial termination, Trial primary completion date:  A Long-term Extension of Study GNC-401 (clinicaltrials.gov) -  Jul 7, 2022   
    P2,  N=33, Terminated, 
    No abstract available Trial completion date: Feb 2023 --> May 2022 | Recruiting --> Terminated | Trial primary completion date: Feb 2023 --> May 2022; Drug product unavailability
  • ||||||||||  temelimab (GNbAC1) / GeNeuro
    Review, Journal:  Promising role of temelimab in multiple sclerosis treatment. (Pubmed Central) -  Jun 9, 2022   
    Our analysis showed statistically non-significant Risk Ratio (RR) of Adverse events in Temelimab group than that in placebo group (1.01 [0.70,1.46]; p-value = 0.94; I = 0%) . Considering the effect of Temelimab on brain lesions, pooled result showed statistically significant Risk Ratio (RR) of brain lesions in placebo group than that in Temelimab group (0.75 [0.69,0.81), p-value < 0.00001, I = 0% Qualitative and quantitative analysis of the trials assessing the safety and efficacy of Temelimab demonstrate that the drug is safe as well as favourable for use in MS patients.
  • ||||||||||  temelimab (GNbAC1) / GeNeuro
    Journal:  HERV-W Envelope Triggers Abnormal Dopaminergic Neuron Process through DRD2/PP2A/AKT1/GSK3 for Schizophrenia Risk. (Pubmed Central) -  Mar 1, 2022   
    In conclusion, we uncovered a relationship between HERV-W ENV and the dopaminergic system in the DA neurons. Considering that GNbAC1, a selective monoclonal antibody to the MSRV-specific epitope, has been promised as a therapy for treating type 1 diabetes and multiple sclerosis (MS) in clinical trials, understanding the precise function of HERV-W ENV in the dopaminergic system may provide new insights into the treatment of schizophrenia.
  • ||||||||||  temelimab (GNbAC1) / GeNeuro
    New P2 trial:  A Long-term Extension of Study GNC-401 (clinicaltrials.gov) -  Sep 16, 2021   
    P2,  N=40, Recruiting, 
  • ||||||||||  temelimab (GNbAC1) / GeNeuro
    Review, Journal:  Human Endogenous Retrovirus as Therapeutic Targets in Neurologic Disease. (Pubmed Central) -  Jun 3, 2021   
    This article ends by describing new, promising therapies, targeting HERV elements, one of which, temelimab, has completed phase II trials with encouraging results in treating MS. The information gathered here may turn helpful in the design of new strategies to unveil epigenetic failures behind HERV-triggered diseases, opening new possibilities for druggable targets and/or for extending the use of temelimab to treat other associated diseases.
  • ||||||||||  opicinumab (BIIB033) / Biogen, temelimab (GNbAC1) / GeNeuro
    Clinical, Journal:  Remyelination in multiple sclerosis: from concept to clinical trials. (Pubmed Central) -  Feb 26, 2020   
    Several of the agents discussed in this review have shown a high potential as future neuroregenerative drugs. However, future trials with more sensitive clinical and paraclinical primary endpoints will be necessary to prove their effectiveness in MS.
  • ||||||||||  temelimab (GNbAC1) / GeNeuro
    Neuroprotective Effects Of Temelimab In Relapsing-remitting Ms Patientsalso Observed In Non-active Patients (Exhibit Hall A, Convention Center - Board no. P222) -  Feb 21, 2020 - Abstract #ACTRIMSForum2020ACTRIMS_FORUM_391;    
    These data are confirmed in the sub-group of patients who are defined as inactive, although not reaching statistical significance due to reduced sample size. These findings support the effects of temelimab on OPCs and microglia is independent from inflammation.
  • ||||||||||  temelimab (GNbAC1) / GeNeuro
    Review, Journal:  Infections, Vaccines and Autoimmunity: A Multiple Sclerosis Perspective. (Pubmed Central) -  Feb 6, 2020   
    Moreover, HERV-targeted therapies such as GNbAC1 (temelimab), EBV-based vaccines for treatment of MS, and the current state regarding the development of T-cell and DNA vaccination are discussed...Despite their historical underperformance, new efforts in creating MS-based vaccines are currently ongoing. MS vaccination programs follow the set back and slow recovery which is widely seen in other fields of medicine.