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Last update 08 May 2025

Temelimab (GeNeuro)

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-HERV-W humanized monoclonal antibodies(GeNeuro), Immunoglobulin G4, anti-(multiple sclerosis-associated retrovirus viral envelope protein) (human-mus musculus monoclonal gnbac1 heavy chain), disulfide with human-mus musculus monoclonal gnbac1 kappa-chain, dimer, Temelimab

+ [5]

Target

ERV-Env

Action

inhibitors

Mechanism

ERV env inhibitors(Envelope ERV derived genes inhibitors)

Therapeutic Areas

Infectious DiseasesNervous System DiseasesRespiratory Diseases

Active Indication

Post Acute COVID 19 SyndromeNeuropsychiatric syndrome

Inactive Indication

Diabetes Mellitus, Type 1Multiple SclerosisMultiple sclerosis relapse+ [1]

Originator Organization

GeNeuro SA

Active Organization

GeNeuro SAGeNeuro SA (Switzerland)

Inactive Organization

GeNeuro Australia PTY Ltd

Les Laboratoires Servier SASGeNeuro Innovation SAS

License Organization

Les Laboratoires Servier SASGeNeuro SAGeNeuro Innovation SAS

+ [1]

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Structure/Sequence

Sequence Code 1297997H

Source: *****

Sequence Code 1298001L

Source: *****

Clinical Trials associated with Temelimab (GeNeuro)

NCT05497089

/ CompletedPhase 2

Temelimab as a Disease Modifying Therapy in Patients With Neurological, Neuropsychological, and Psychiatric (=Neuropsychiatric) Symptoms in Post-COVID 19 or Postacute Sequelae of COVID-19 (PASC) Syndrome

This study is a Phase 2, 24-week, randomized, prospective, double-blind, multicenter study in patients experiencing neuropsychiatric symptoms and functional impairment in the course of PASC. The purpose of the study is to evaluate the efficacy and safety of Temelimab as a treatment for PASC neuropsychiatric symptoms in patients who had severe acute respiratory syndrome coronavirus - type 2 (SARS-CoV-2) infection but did not undergo intensive care treatment during the acute period. Patients meeting eligibility criteria will be randomized to Temelimab or placebo in a 1:1 ratio via interactive voice/web response system to obtain 182 protocol completers. The randomization will be stratified by age (≤65 years versus >65 years).

Start Date29 Aug 2022

Sponsor / Collaborator

GeNeuro SA

NCT05049161

/ TerminatedPhase 2

A Long-term Extension of Study GNC-401 With Temelimab in Patients With Relapsing Forms of Multiple Sclerosis (RMS) Under Treatment With Rituximab

This Phase II study is a monocenter, long-term extension study of study GNC-401 and will start after individual completion of Week 48 of the GNC-401 study. At entry, all patients will receive active treatment with temelimab. The patients of the placebo group in study GNC-401 will be re-randomized to temelimab 18 mg/kg, 36 mg/kg or 54 mg/kg (1:1:1), while the patients who received temelimab in study GNC-401 will continue with the same dose in study GNC-402. Following final analysis of the results of the GNC-401 study, the Sponsor may switch all patients to an optimal dose of temelimab based on safety and efficacy demonstrated in the GNC-401 study.

Start Date27 Aug 2021

Sponsor / Collaborator

GeNeuro Innovation SAS

NCT04480307

/ CompletedPhase 2

A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS)

Randomized, double-blind, placebo-controlled Phase IIa clinical study, assessing safety, tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg).
In this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.

Start Date17 Jun 2020

Sponsor / Collaborator

GeNeuro Innovation SAS

100 Clinical Results associated with Temelimab (GeNeuro)

100 Translational Medicine associated with Temelimab (GeNeuro)

100 Patents (Medical) associated with Temelimab (GeNeuro)

Literatures (Medical) associated with Temelimab (GeNeuro)

29 Jun 2023·Journal of virology

CancerHERVdb: Human Endogenous Retrovirus (HERV) Expression Database for Human Cancer Accelerates Studies of the Retrovirome and Predictions for HERV-Based Therapies.

Article

Author: Peckham-Gregory, Erin C ; Stricker, Erik ; Scheurer, Michael E

In this study, we sought to create a database summarizing the expression of human endogenous retroviruses (HERVs) in various human cancers. HERVs are suitable therapeutic targets due to their abundance in the human genome, overexpression in various malignancies, and involvement in various cancer pathways. We identified articles on HERVs from PubMed and then prescreened and automatically categorized them using the portable document format (PDF) data extractor (PDE) R package. We discovered 196 primary research articles with HERV expression data from cancer tissues or cancer cell lines. HERV RNA and protein expression was reported in brain, breast, cervical, colorectal, endocrine, gastrointestinal, kidney/renal/pelvis, liver, lung, genital, oral cavity, pharynx, ovary, pancreas, prostate, skin, testicular, urinary/bladder, and uterus cancers, leukemias, lymphomas, and myelomas. Additionally, we discovered reports of HERV RNA-only overexpression in soft tissue cancers including heart, thyroid, bone, and joint cancers. The CancerHERVdb database is hosted in the form of interactive visualizations of the expression data and a summary data table at https://erikstricker.shinyapps.io/cancerHERVdb/. The user can filter the findings according to cancer type, HERV family, HERV gene, or a combination thereof and easily export the results with the corresponding reference list. 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. In summary, the CancerHERVdb allows cross-study comparisons, encourages data exploration, and informs about potential off-target effects of HERV-targeting treatments. IMPORTANCE Human endogenous retroviruses (HERVs), which in the past have inserted themselves in various regions of the human genome, are to various degrees activated in virtually every cancer type. While a centralized naming system and resources summarizing HERV levels in cancers are lacking, the CancerHERVdb database provides a consolidated resource for cross-study comparisons, data exploration, and targeted searches of HERV activation. The user can access data extracted from hundreds of articles spanning 25 human cancer categories. 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.

25 Jun 2023·World journal of virology

Etiopathogenic theories about long COVID.

Review

Author: Del Carpio-Orantes, Luis

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).

01 Aug 2022·Multiple Sclerosis and Related Disorders

Temelimab for MS and SARS-CoV-2: Could it be a double-edged blessing?

Letter

Author: Mouliou, Dimitra S ; Dardiotis, Efthimios

A review.Human Endogenous Retroviruses (HERVs) are genetic remnants embedded in the human genome (~8%), as a result of ancient retroviral infections, amongst which the HERV-W subgroup has been thoroughly investigated.Dysimmunity and inflammation in Multiple Sclerosis (MS) have also been linked with HERV-W.Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) was identified from a cluster of pneumonia cases in Wuhan, China, and resulted in Coronavirus Disease 2019 (COVID-19) disease, being glob - ally diagnosed for more than 2 years, while global vaccination strategies are evident for more than a year, now.Temelimab (GNbAC1) is an Ig (Ig)G4 monoclonal antibody targeting HERW-W protein; this immunotherapy was revealed to have no effect on acute adaptive immune inflammation, although it did show preliminary radiol. indicators of anti-neurodegenerative benefits, and current data support that treatment for progressive MS.Medical centers are striving to evaluate temelimab as a therapeutic treatment, both to prevent immune system hyper-activation in newly infected patients and to treat severe neurol. and psychiatric syndromes in patients with long-COVID syndrome.Combining the facts that many people have been infected with SARS-CoV-2 and that certain cases show prolonged PCR test positivity, several have been vaccinated against COVID-19 and that SARS-CoV-2 may in - fluence MS disease course or clin. emergence, we highlight the need for temelimab to be urgently studied particularly for MS vaccinated and non-vaccinated patients with COVID-19.Although more studies are required to reveal the relationship of COVID-19 and MS exacerbations, current evidence suggests a potential linkage, thus may different teme - limab treatment schedules and dosages are needed.Finally, we highlight the need for the next step after temelimab clin. trials, to consider that the drug will be administered in MS cases that have been vaccinated or non-vaccinated people as well as in those with and without a history of COVID-19, thus the potential drug dosage-efficacy in MS patients could be influenced by these factors.

News (Medical) associated with Temelimab (GeNeuro)

13 Nov 2024

·www.prnewswire.com

75+ Key Companies Charting New Frontiers in Multiple Sclerosis Therapeutic Space | DelveInsight

Multiple sclerosis (MS) is a chronic neurological disorder affecting the central nervous system (CNS), particularly the brain, spinal cord, and optic nerves. Continuous research has led to new drug developments, particularly disease-modifying therapies (DMTs) that slow MS progression. Monoclonal antibodies, oral therapies, and infusion treatments are among the most promising options and drives the multiple sclerosis market. LAS VEGAS, Nov. 13, 2024 /PRNewswire/ -- DelveInsight's ' Multiple Sclerosis Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline multiple sclerosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the multiple sclerosis pipeline domain. Key Takeaways from the Multiple Sclerosis Pipeline Report DelveInsight's multiple sclerosis pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for multiple sclerosis treatment. Key multiple sclerosis companies such as Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape. Promising multiple sclerosis pipeline therapies such as GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials. In October 2024, Immunic, Inc. reported favorable results from the non-binding interim futility analysis of its Phase 3 ENSURE trial, which is evaluating its lead candidate, vidofludimus calcium (IMU-838), a nuclear receptor-related 1 (Nurr1) activator, for the treatment of relapsing multiple sclerosis (RMS). In October 2024, Immunic, Inc. announced a positive outcome of the non-binding, interim futility analysis of its Phase III ENSURE program, investigating lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned. In September 2024, Roche, secured FDA approval for an injectable form of its blockbuster multiple sclerosis treatment, Ocrevus, reducing patient treatment time and potentially helping the company stay ahead of increasing competition. In September 2024, Sanofi announced the outcomes of Phase III clinical trials of its investigational oral brain-penetrant BTK inhibitor, tolebrutinib, aimed at treating multiple sclerosis (MS). These studies, namely HERCULES, GEMINI 1, and GEMINI 2, have provided mixed results, with the HERCULES trial meeting its primary endpoint while the GEMINI trials did not. The HERCULES study focused on the efficacy and safety of tolebrutinib in individuals with non-relapsing secondary progressive MS (nrSPMS) compared to a placebo. In August 2024, Abata Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ABA-101 for the treatment of patients with progressive multiple sclerosis (MS). The FDA recently cleared ABA-101's Investigational New Drug (IND) application, and initiation of a first-in-human (FIH) Phase I study is imminent. In August 2024, TG Therapeutics announced that the FDA has cleared an investigational new drug (IND) application submitted by TG Therapeutics for azercabtagene zapreleucel (azer-cel), an investigational allogeneic chimeric antigen receptor T-cell (CAR-T) therapy, for a phase 1 clinical trial in patients with progressive multiple sclerosis (MS). In January 2024, Kyverna Therapeutics, Inc. announced it received fast-track designation by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of multiple sclerosis (MS). Request a sample and discover the recent advances in multiple sclerosis treatment drugs @ Multiple Sclerosis Pipeline Report The multiple sclerosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage multiple sclerosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the multiple sclerosis clinical trial landscape. Multiple Sclerosis Overview Multiple sclerosis is a chronic autoimmune disorder that affects the central nervous system, leading to the deterioration or permanent damage of myelin, the protective sheath surrounding nerve fibers. While the exact cause of multiple sclerosis remains unclear, it is believed to involve a combination of genetic predisposition, environmental factors, and possibly viral infections. Common symptoms of multiple sclerosis include fatigue, difficulty walking, numbness or tingling in the limbs, muscle weakness, and vision problems, which can vary significantly among individuals and may evolve over time. Diagnosis typically involves a combination of neurological examinations, magnetic resonance imaging (MRI) to detect lesions in the brain and spinal cord, and sometimes lumbar puncture to analyze cerebrospinal fluid for inflammatory markers. While there is no cure for multiple sclerosis, treatment options aim to manage symptoms, reduce the frequency and severity of relapses, and slow disease progression. This may include disease-modifying therapies (DMTs), corticosteroids for acute exacerbations, and symptomatic treatments such as physical therapy, pain management, and lifestyle modifications. Early diagnosis and a tailored treatment plan are crucial for improving the quality of life for those living with multiple sclerosis. Find out more about multiple sclerosis treatment drugs @ Drugs for Multiple Sclerosis Treatment A snapshot of the Multiple Sclerosis Pipeline Drugs mentioned in the report: Learn more about the emerging multiple sclerosis pipeline therapies @ Multiple Sclerosis Clinical Trials Multiple Sclerosis Therapeutics Assessment The multiple sclerosis pipeline report proffers an integral view of the multiple sclerosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Multiple Sclerosis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Immunomodulators, MHC class II gene modulators, Agammaglobulinaemia tyrosine kinase inhibitors, Dihydroorotate dehydrogenase inhibitors, Nuclear receptor subfamily 4 group A member 2 agonists, CD20 antigen inhibitors, Energy metabolism stimulants; Immunomodulators, Lysine-specific demethylase 1 inhibitors, Monoamine oxidase B inhibitors, Protein-arginine deiminase inhibitors, Immunostimulants Key Multiple Sclerosis Companies: Mapi Pharma, Novartis, Immunic, Biocad, Apimeds, Genentech (Roche), AB Science, Celltrion, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, BrainStorm Cell Therapeutics, NeuroSense Therapeutics, Denali Therapeutics Inc., Sanofi, MediciNova, Biogen, Tiziana Life Sciences, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Eli Lilly and Company, Axsome Therapeutics, Accure therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio-Technology Co., Ltd., ImCyse, Lucid Psycheceuticals, Immune Response BioPharma, Guangzhou Lupeng Pharmaceutical, Kyowa Kirin, Nura Bio, Bristol-Myers Squibb, ImStem Biotechnology, Hoffmann-La Roche, LAPIX Therapeutics, Motric Bio, Immunophage Biotech, NervGen, FibroBiologics, Kyverna Therapeutics, GlaxoSmithKline, PolTREG, Cyxone, Biohaven Pharmaceuticals, HuniLife Biotechnology, GlobeStar Therapeutics, Anokion, Medsenic, ZyVersa Therapeutics, Alumis Inc., Axoltis Pharma, Barricade Therapeutics, BioNxt Solutions, Eikonoklastes Therapeutics, 4D Pharma, Gossamer Bio, Pasithea Therapeutics, Synaptogenix, Monte Rosa Therapeutics, Immix Biopharma, f5 Therapeutics, Autobahn Therapeutics, Biosenic, Polpharma Biologics, Find Therapeutics, TeraImmun, AptaTargets, Trethera, Aditxt, SetPoint Medical, Sarepta Therapeutics, Nucleome Therapeutics, Vaccinex Inc., and others are evaluating new multiple sclerosis drugs to improve the treatment landscape. Key Multiple Sclerosis Pipeline Therapies:GA Depot, Remibrutinib, Tolebrutinib, IMU 838, BCD-132, Apitox, Fenebrutinib, SAR 441344, CT-P53, CNM-Au8, Orelabrutinib, Vafidemstat, Temelimab, Elezanumab, NurOwn (MSC-NTF cells), PrimeC, SAR4433820, Ibudilast, BIIB091, Foralumab, ATL1102, RC18, ATA188, PIPE-307, Pirtobrutinib, LY3541860, Solriamfetol, Act-01, SCM-010, UMSC01, IMCY-0141, Lucid-MS, NeuroVax, LP-168, NB-4746, CC-97540, IMS-001, RO7121932, BMS-986196, LPX-TI641, MTR-601, IPG-11406, IPG-1094, NVG-291, CYMS-101, KYV-101, PIPE-791, GSK 3888130B, PTG-007, T 20K, BHV-8000, HuL001, Amethyst™, ANK 700, Arscimed, A-005, NX210c, Research programme: CAR-TREG, TASIN-1, Cladribine ODF, ET-101, MRx0002, GB7208, PAS-002, Bryostatin-1, MRT-6160, NXC-201, Research Program: Cytokine reduction, ABX-002, Arsenic trioxide, LL-341070, PB018, FTX 101, TI-235, TRE 515, NT-0007, NT-0002, NVG300, and others are under different phases of multiple sclerosis clinical trials. Dive deep into rich insights for new drugs for multiple sclerosis treatment, visit @ Multiple Sclerosis Drugs Table of Contents For further information on the multiple sclerosis pipeline therapeutics, reach out @ Multiple Sclerosis Treatment Drugs Related Reports Multiple Sclerosis Market Multiple Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key multiple sclerosis companies including Immune Response BioPharma, Inc., Clene Nanomedicine, Genzyme, ImStem Biotechnology, Rho, Inc., Bristol-Myers Squibb, TG Therapeutics, Inc., Hoffmann-La Roche, Atara Biotherapeutics, Immunic AG, Celgene, Anokion SA, Sanofi, Actelion, Biogen, Supernus Pharmaceuticals, Inc., GeNeuro SA, HuniLife Biotechnology, Inc., Emerald Health Pharmaceuticals, RemeGen Co., Ltd., Antisense Therapeutics, Biocad, AB Science, Genentech, Novartis, Pipeline Therapeutics, ASLAN Pharmaceuticals, GlaxoSmithKline, Lucid Psycheceuticals, Voronoi, Hanmi Pharmaceutical, Mapi Pharma, f5 Therapeutics, Autobahn Therapeutics, AstraZeneca, ZyVersa Therapeutics, RedHill Biopharma, Gossamer Bio, Sarepta Therapeutics, BrainStorm Cell Limited, CytoDyn, Pear Therapeutics, Solstice Neurosciences, ProJenX, among others. Multiple Sclerosis Epidemiology Forecast Multiple Sclerosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted multiple sclerosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Relapsing Multiple Sclerosis Pipeline Relapsing Multiple Sclerosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key relapsing multiple sclerosis companies, including ASLAN Pharmaceuticals, GlaxoSmithKline, Lucid Psycheceuticals, Voronoi, Hanmi Pharmaceutical, among others. Relapsing-Remitting Multiple Sclerosis Pipeline Relapsing-Remitting Multiple Sclerosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMS companies, including TG Therapeutics, Novartis, Sanofi, Cinnagen, Polpharma Biologics, Immunic, Mapi Pharma, Biocad, Apimeds, Genentech (Roche), Merck, Immune Response BioPharma, Clene Nanomedicine, InnoCare Pharma, Oryzon Genomics, GeNeuro SA, AbbVie, Emerald Health Pharmaceuticals, GlaxoSmithKline, RedHill Biopharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultFast TrackCell TherapyImmunotherapy

28 Jun 2024

·www.fiercebiotech.com

GeNeuro's long COVID trial fails, triggering layoffs and search for strategic alternatives

GeNeuro joins a list of companies that have swung at long COVID and missed. GeNeuro reported (PDF) the near-total failure of its phase 2 long COVID trial Friday, telling investors it saw no effect on the primary endpoint and most secondary goals. The Swiss biotech responded by laying off staff and seeking strategic alternatives. Geneva-based GeNeuro began testing the anti-HERV-W-Env antibody temelimab, also called GNC-501, in long COVID after seeing evidence immune dysregulation drives the post-infection symptoms. One study found the W-ENV protein on lymphocytes in people hospitalized with COVID-19. If expression continued after infection, the protein could damage cells and cause long-term neurological symptoms. GeNeuro enrolled 203 people with long COVID at sites in Switzerland, Spain and Italy in the phase 2. All subjects tested positive at the start of the study for HERV-W-Env, the protein targeted by temelimab and the potential driver of long COVID’s neurological symptoms. However, targeting the protein failed to improve health outcomes. GeNeuro saw no clinically meaningful improvement compared to placebo on the primary endpoint, which assessed fatigue, or on the majority of secondary objectives. Work to understand the data and the effect of temelimab on more biomarkers is continuing. “Preliminary analyses suggest that shorter disease duration at time of inclusion, as well as the evolution of the underlying HERV-W ENV status, may have an impact on the efficacy outcome measures,” the firm said in a statement. GeNeuro needed a win. A 5 million euro ($5.3 million) financing in February extended (PDF) the biotech’s cash runway into the third quarter, but, beyond that, the picture is unclear. The board responded to the long COVID failure by further reducing GeNeuro’s workforce and spending to conserve cash as it looks for strategic alternatives. “The Swiss parent company GeNeuro SA has made redundant seven of its nine employment agreements, including all of the executive management. All employees and managers will work through their notice periods, of up to six months, to execute the strategy that will be defined by the board over the coming days,” the company said. GeNeuro joins a list of companies that have swung at long COVID and missed. Pfizer's Paxlovid recently failed in the indication. Tonix Pharmaceuticals found its drug candidate had no effect on pain symptoms. Axcella ran out of money while going after long COVID.

Phase 2Clinical Result

11 Dec 2023

·www.businesswire.com

Independent Data Monitoring Committee Recommends Continuing the Trial Evaluating Temelimab in Long COVID Without Any Modifications

GENEVA--( BUSINESS WIRE )--Regulatory News: GeNeuro (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical company focused on stopping causal factors driving the progression of neurodegenerative and autoimmune diseases such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Post-Acute Sequelae of COVID-19 (PASC, Long-COVID or post-COVID), today announced that, as planned in the Study Protocol, the Independent Data Monitoring Committee met to review the unblinded safety and efficacy data of the first 90 patients after three months of treatment. Based on the planned interim analysis of efficacy and safety data, which included an analysis for futility, the IDMC recommended to “continue the trial without any modifications”. The study “Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome" is a randomized, placebo-controlled, biomarker-based Phase 2 clinical trial evaluating the effect of temelimab treatment on the clinical course of these symptoms. This trial enrolled 203 patients in 14 clinical centers in Switzerland, Spain and Italy, who were affected by neurological syndromes post-COVID, and who tested positive to the presence of W-ENV in their blood. W-ENV is suspected to have a major role in the persistence of inflammation and in the neurological symptoms affecting these patients, and temelimab is a highly specific neutralizing anti-W-ENV-antibody. GeNeuro’s precision medicine approach allows to identify, within the millions of patients affected by long-COVID, those for whom the treatment may be relevant. Results are expected in June 2024. About Temelimab The development of temelimab (GNbAC1) is the result of more than 25 years of research into human endogenous retroviruses (HERVs), including 15 years within Institut Mérieux and INSERM before GeNeuro was founded in 2006. HERVs have been incorporated into the human genome during the evolution of mankind and typically remain “silent genes”, but may be activated under certain conditions and were found to be involved in the development of auto-immune diseases. The viral envelope protein encoded by the HERV-W family (W-ENV) has been found to be pro-inflammatory and pathogenic to nervous system cells. W-ENV is found in the brains of MS patients, and particularly in active lesions. In two Phase II multiple sclerosis trials Temelimab has shown promising results on MRI features and liquid biomarkers related to neurodegenerative processes such as brain atrophy. Temelimab is a neutralizing anti-W-ENV-antibody; by this capacity it simultaneously blocks inflammatory and neurodegenerative processes. Given that W-ENV has no known physiological function, temelimab has demonstrated a good safety and tolerability profile in the current study, with no effect on the patient’s immune system, which bears out the profile observed in all clinical trials carried out to date. About GeNeuro GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by HERVs, which represent 8% of human DNA. For more information, visit: www.geneuro.com . Disclaimer This press release contains certain forward - looking statements and estimates concerning GeNeuro’s financial condition, operating results, strategy, projects and future performance and the markets in which it operates. Such forward-looking statements and estimates may be identified by words such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions. They incorporate all topics that are not historical facts. Forward looking statements, forecasts and estimates are based on management’s current assumptions and assessment of risks, uncertainties and other factors, known and unknown, which were deemed to be reasonable at the time they were made but which may turn out to be incorrect. Events and outcomes are difficult to predict and depend on factors beyond the Company’s control. Consequently, the actual results, financial condition, performances and/or achievements of GeNeuro or of the industry may turn out to differ materially from the future results, performances or achievements expressed or implied by these statements, forecasts and estimates. Owing to these uncertainties, no representation is made as to the correctness or fairness of these forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.

Phase 2Clinical Result

100 Deals associated with Temelimab (GeNeuro)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis	Preclinical	Switzerland	GeNeuro Innovation SAS	01 Jul 2012
Multiple Sclerosis, Relapsing-Remitting	Discovery	Croatia	GeNeuro SA	01 Apr 2016
Multiple Sclerosis, Relapsing-Remitting	Discovery	Germany	Les Laboratoires Servier SAS	01 Apr 2016
Multiple Sclerosis, Relapsing-Remitting	Discovery	Estonia	Les Laboratoires Servier SAS	01 Apr 2016
Multiple Sclerosis, Relapsing-Remitting	Discovery	Spain	GeNeuro SA	01 Apr 2016
Multiple Sclerosis, Relapsing-Remitting	Discovery	Spain	Les Laboratoires Servier SAS	01 Apr 2016
Multiple Sclerosis, Relapsing-Remitting	Discovery	Germany	GeNeuro SA	01 Apr 2016
Multiple Sclerosis, Relapsing-Remitting	Discovery	Bulgaria	Les Laboratoires Servier SAS	01 Apr 2016
Multiple Sclerosis, Relapsing-Remitting	Discovery	Croatia	Les Laboratoires Servier SAS	01 Apr 2016
Multiple Sclerosis, Relapsing-Remitting	Discovery	Russia	Les Laboratoires Servier SAS	01 Apr 2016

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04480307 (ProTEct-MS, CTgov)	Phase 2	Multiple sclerosis relapse	41	temelimab 18 mg/kg (Temelimab 18 mg/kg)	(qhdyhyoeys) = mvwochyacu intmpaianj (nwjnrznrhy, wbxhhapipt - iljqqmqhjm) View more	-	07 Nov 2024
				temelimab 36 mg/kg (Temelimab 36 mg/kg)	(qhdyhyoeys) = tsooucormk intmpaianj (nwjnrznrhy, nfspwbpnoq - orweekfeml) View more
NCT04480307 (ProTEct-MS, ECTRIMS2022)	Phase 2	Multiple sclerosis relapse serum neurofilament light chain (NfL) \| glial fibrillary acidic protein (GFAP)	41	Temelimab 18mg/kg	ywetuweiyp(kjifaycodj) = ipagxehmdz lakgozwnpa (owieaffxxn )	-	12 Oct 2022
				Temelimab 36mg/kg	ywetuweiyp(kjifaycodj) = kourpuroxy lakgozwnpa (owieaffxxn )
NCT02782858 (CHANGE-MS, Pubmed) Manual	Phase 2	Multiple Sclerosis	270	temelimab	aobfkoxqqz(ffctkfzlkv): P-Value = 0.014	Negative	09 Jul 2021
				Placebo
NCT03179423 (Pubmed \| Diabetes Obes Metab) Manual	Phase 2	Diabetes Mellitus, Type 1	64	temelimab	(rsmguqaubj) = Temelimab was well tolerated without any group difference in the frequency or severity of adverse events. nxlxedtpgg (tnzgmedkfn ) View more	Positive	01 Jul 2020
				Placebo
NCT02782858 (CHANGE-MS, ECTRIMS2019)	Phase 2	Multiple Sclerosis, Relapsing-Remitting pHERV-W env	270	Temelimab 18 mg/kg	qjvbuccxdi(cvzambplqm) = jstmbzgybj hrmrjqjqbp (ivmknfdsfm )	Positive	10 Sep 2019
				Comparator Group (originally randomized to placebo)	qjvbuccxdi(cvzambplqm) = irosdhsakj hrmrjqjqbp (ivmknfdsfm )
NCT03574428 (Pubmed \| Med Lett Drugs Ther) Manual	Phase 1	Multiple Sclerosis	24	Temelimab	(nzhjlcqstt) = Temelimab was well tolerated, with no particular adverse drug reactions at any dos ugkubquuhr (ghedoahksu )	Positive	01 Sep 2019
				Placebo
GNC-003 (ACTRIMS2019)	Phase 2	Multiple Sclerosis, Relapsing-Remitting pHERV-W env	270	GNbAC1 18 mg/kg	(fkkgcilqnk) = GNbAC1 18 mg/kg maintained myelin integrity through Week 48, as measured by Magnetization Transfer Ratio (MTR), in normal-appearing white matter and cerebral cortex zpifbunfzc (ekfqrhtxku )	Positive	07 May 2019
AAN2016	Phase 2	Multiple Sclerosis MSRV-Env \| TLR4 activation markers	260	GNbAC1 6 mg/kg	wedbzefnwm(uhfusiaxoj) = rlxvghsezq temmnglrdp (qjvfpzeeie )	-	05 Apr 2016
				GNbAC1 36 mg/kg	wedbzefnwm(uhfusiaxoj) = sasunljkts temmnglrdp (qjvfpzeeie )
NCT01639300 (Pubmed \| Mult Scler) Manual	Phase 2	Multiple Sclerosis	10	GNbAC1	(dlbvqqulwx) = GNbAC1 was well tolerated in all patients. rmmqdynivl (mofkpimkuc )	Positive	01 Jun 2015
				Placebo

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