etokimab (ANB020) / AnaptysBio - LARVOL DELTA

Targeting alarmins in asthma- From the bench to the clinic. (PubMed, J Allergy Clin Immunol) - "Tezepelumab, an anti-TSLP antibody has already been approved for the treatment of severe asthma. In this review we discuss our current understanding of alarmin biology with a primary focus on allergic airway diseases. We link the mechanistic corollaries to the clinical implications and advances in drug development targeting alarmins-focusing on currently approved treatments, those under study, as well as future potential targets in the alarmin signaling pathways."

Journal • Review • Allergy • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL33 • IL5

A role for anti-IL33 strategies to limit the epithelial rhinoviral response? (ERS 2024) - " HBECs were pre-treated with 0.1-10mg/ml of anti-IL33 (Etokimab or Invivogen) antibodies or PBS vehicle control for 1hr, followed by a 24hr challenge with RV (MOI:1), 50ng/ml IL33 or both... RV infection of airway epithelial cells in an IL33 high environment drives amplified inflammation including IL8 and TSLP. Anti-IL33 directly targets RV effects on HBEC particularly in carriers of the IL1RL1 asthma genotype."

Asthma • Immunology • Infectious Disease • Inflammation • Respiratory Diseases • CXCL10 • CXCL8 • IL33 • TSLP

Biologic therapy for food allergy. (PubMed, J Food Allergy) - "A number of biologics that target key molecules known to be involved in food allergy are under investigation, including anti-immunoglobulin E therapy (omalizumab), anti-interleukin (IL) 4 receptor a (dupilumab), anti-IL-5 (mepolizumab and reslizumab), and anti-IL-5R (benralizumab), anti-IL-33 (etokimab), and peanut DNA plasmid vaccines. In the era of precision medicine, the future of food allergy looks promising, and biologics will provide treatment as well as further insights into the molecular mechanisms associated with food allergy."

Journal • Allergy • Food Hypersensitivity • Immunology • IL33 • IL5

New biologics for food allergy. (PubMed, Curr Opin Allergy Clin Immunol) - "Biologics hold promising potential for food allergy treatment. Tailoring therapeutic approaches based on shared decision-making becomes pivotal. While omalizumab remains a significant option, next-generation anti-IgE antibodies and agents targeting alarmins exhibit unique strengths. Dupilumab, despite limited success as monotherapy, shows promise as an adjunct for OIT. Careful consideration of treatment goals, patient preferences, and the evolving landscape of biologics will shape future clinical practice, offering allergists an expanded toolbox for personalized food allergy management."

Journal • Allergy • Food Hypersensitivity • Immunology • IL33 • IL4 • IL4R

Etokimab: Protection of patents related to the antibody sequence of etokimab and its variants, methods of use and related matters until Jan 2035 (AnaptysBio) - Annual Report 2023

Patent • Atopic Dermatitis • Dermatology

Application of biologicals in patients with food allergies (PubMed, Rev Alerg Mex) - "TNX-901 and omalizumab have demonstrated increased reaction thresholds, reducing adverse events in peanut-allergic patients. Dupilumab, blocking the IL-4 receptor, shows positive results in both food allergies and eosinophilic esophagitis. Antibodies against alarmins and anti-IL-5, such as etokimab and mepolizumab, have proven efficacy in preclinical studies and clinical trials. While further studies are needed to establish their practical clinical use and determine suitability for different types of food allergies, these monoclonal antibodies present a promising horizon for the treatment of such conditions."

Journal • Allergy • Eosinophilic Esophagitis • Food Hypersensitivity • Gastrointestinal Disorder • Immunology • IL4 • IL5

An overview of new and emerging antibody therapies for moderate-severe atopic dermatitis in adults. (PubMed, Expert Rev Clin Pharmacol) - "Some monoclonal antibodies, such as dupilumab (anti-IL-4 Rα) and tralokinumab (anti-IL13) are already approved for the treatment of moderate-to-severe atopic dermatitis, and numerous articles in the literature have demonstrated their efficacy and safety...Data from phase 2b and phase III clinical trials in moderate-to-severe atopic dermatitis in adults indicate that these drugs have a promising efficacy and safety profile. Monoclonal antibodies currently under investigation will be available in the coming years to enrich the therapeutic choice of new alternatives that are valid both in terms of efficacy and safety."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13 • IL4

Pathogenesis-based application of biologics for chronic rhinosinusitis: Current and future perspectives. (PubMed, Auris Nasus Larynx) - "Currently, a completed phase 3 clinical trial for biologics for severe CRSwNP with inadequate response to surgery and/or intranasal corticosteroids, including omalizumab (anti-IgE), mepolizumab (anti-IL-5), benralizumab (anti-IL-5Rα), and dupilumab (anti-IL-4Rα), have all shown efficacy. Similar phase 3 clinical trials for tezepelumab (anti-TSLP) and etokimab (anti-IL-33) are now underway and completed, respectively...A definition of complete and/or clinical remission of CRS is also needed to determine when to reduce or discontinue biologics. In addition, more precise basic research on CRS, such as endotyping and genotyping, will need to be undertaken in order to determine novel targets for biologics."

Journal • Review • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL33 • IL5

Exploring novel approaches to food allergy management. (PubMed, J Am Assoc Nurse Pract) - "Omalizumab, an anti-IgE therapy, dupilumab, an interleukin-4Ra receptor monoclonal antibody, and etokimab, an anti-IL-33, are all being studied for the treatment of food allergy. There is hope that these novel therapies for FAs will be a viable option translated to the practice setting in the near future, so that strict avoidance is not the only treatment plan for FAs. Nurse practitioners can support their patients with FAs and their families by keeping abreast of progress in food allergy research and assisting patients to consider novel treatment options, when appropriate, using shared decision making."

Journal • Allergy • Food Hypersensitivity • Immunology • Pediatrics • IL33

Not Available (PubMed, Arerugi) - No abstract available

Journal

ATLAS: Efficacy, Safety, and Pharmacokinetic Profile of Etokimab (ANB020) in Adult Participants With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=302 | Completed | Sponsor: AnaptysBio, Inc. | Unknown status ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

EGF is an important modulator of the release of the alarmin IL-33 by human keratinocytes (ISID 2023) - "Background and aims: Etokimab (an anti-IL-33 biologic) has been shown to significantly reduced the clinical severity of atopic dermatitis (AD) in a Phase 2A clinical trial, suggesting an important role for IL-33 in the pathogenesis of this disease... The effect of EGF and cetuximab (an anti-EGFR biologic) on Staphylococcus aureus secretome (SA)-induced IL-33 release induced from human keratinocytes, was assessed in vitro using RNAseq (synthesis), phosphoarray (cell signaling), ELISA and Western blot (release)... The EGFR pathway is an important modulator of IL-33 release. A better understanding of the cellular events that leading to modulation of the alarmin IL-33 by EGF may provide novel therapeutic targets in atopic dermatitis."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL33

Mapping knowledge structure and research of the biologic treatment of asthma: A bibliometric study. (PubMed, Front Immunol) - "The search strategies were as follows: topic: TS=(biologic* OR "biologic* product*" OR "biologic* therap*" OR biotherapy* OR "biologic* agent*" OR Benralizumab OR "MEDI-563" OR Fasenra OR "BIW-8405" OR Dupilumab OR SAR231893 OR "SAR-231893" OR Dupixent OR REGN668 OR "REGN-668" OR Mepolizumab OR Bosatria OR "SB-240563" OR SB240563 OR Nucala OR Omalizumab OR Xolair OR Reslizumab OR "SCH-55700" OR SCH55700 OR "CEP-38072" OR CEP38072 OR Cinqair OR "DCP-835" OR DCP835 OR Tezspire OR "tezepelumab-ekko" OR "AMG-157" OR tezspire OR "MEDI-9929" OR "MEDI-19929" OR MEDI9929 OR Itepekimab OR "REGN-3500"OR REGN3500 OR "SAR-440340"OR SAR440340 OR Tralokinumab OR "CAT-354" OR Anrukinzumab OR "IMA-638" OR Lebrikizumab OR "RO-5490255"OR "RG-3637"OR "TNX-650"OR..."

Journal • Asthma • Cough • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Systematic review of monotherapy with biologicals for children and adults with IgE-mediated food allergy. (PubMed, Clin Transl Allergy) - "There is not yet enough certainty to support offering etokimab or omalizumab widely for food allergy. Clinicians may consider the merits for individuals, but large randomised trials with standardised measures are needed to confirm the safety, efficacy and most suitable candidates, doses and durations of treatment before more universal use."

Journal • Monotherapy • Review • Allergy • Food Hypersensitivity • Immunology • Inflammation

IL-1 Family Cytokines in Inflammatory Dermatoses: Pathogenetic Role and Potential Therapeutic Implications. (PubMed, Int J Mol Sci) - "Therefore, therapeutic targeting of IL-1 pathways has been studied, and several monoclonal antibodies are currently being assessed in clinical trials. So far, promising results have been obtained with anti-IL-36R spesolimab and imsidolimab in pustular psoriasis, and their efficacy is being tested in other conditions."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Psoriasis

Comparative efficacy and safety of monoclonal antibodies and aspirin desensitization for chronic rhinosinusitis with nasal polyposis: a systematic review and network meta-analysis. (PubMed, J Allergy Clin Immunol) - "Multiple biologics and ASA-D credibly improve patient-important outcomes, with clinically important differences in effects among agents, and dupilumab uniquely ranking among the most beneficial for all outcomes studied."

Journal • Retrospective data • Review • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

"#EAACI2021 - This is fascinating! #Etokimab therapy in #foodallergy" (@winder_gill)

Food Hypersensitivity • Immunology

Novel Targeted Biological Agents for the Treatment of Atopic Dermatitis. (PubMed, BioDrugs) - "If topical therapies fail, phototherapy and systemic immunosuppressant therapies, such as ciclosporin, methotrexate, and azathioprine, can be considered...Dupilumab is the first biological agent approved for the treatment of AD in patients aged 6 years and older in the United States. Tralokinumab, lebrikizumab, and nemolizumab have also been confirmed to have significant efficacy against AD in phase III or IIb clinical trials. Also, fezakinumab was effective in severe AD patients in a phase IIa trial. However, phase II trials of ustekinumab, tezepelumab, etokimab, secukinumab, and omalizumab have failed to meet their primary endpoints. Phase II trials of GBR 830 and KHK 4083 are ongoing. In general, further studies are needed to explore new therapeutic targets and improve the efficacy of biological agents."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immune Modulation • Immunology • Inflammation • IL13 • IL17A • IL33 • TSLP

The use of biologics in food allergy. (PubMed, Clin Exp Allergy) - "The ever better knowledge of the mechanisms of food allergy allowing these developments will improve not only the perspective of patients with the most serious immediate food allergies such as anaphylaxis, but also those of patients with related diseases such as atopic dermatitis, eosinophilic esophagitis, and EGIDs. Biologics are also intended to complement OIT strategies that have developed over the years."

Journal • Review • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Eosinophilic Esophagitis • Food Hypersensitivity • Gastroenterology • Gastrointestinal Disorder • Immunology • Pediatrics • CXCL8 • IL10 • IL12A • IL13 • IL33 • IL4 • IL5 • IL6 • TSLP

[VIRTUAL] Biologics in the Pipeline for Atopic Dermatitis: Symposium for Inflammatory Skin Disease 2021® Highlights (DERF-ISDS 2021) - "Kircik also cautioned that studies for dupilumab demonstrated a small subset of patients in which dupilumab may exacerbate AD.A new emerging biologic for AD, tralokinumab (fully human monoclonal IgG4 antibody) potently binds and neutralizes IL-13. The TREBLE trial for lebrikizumab, another anti-IL13 monoclonal antibody, demonstrated 33% of patients had a clear or almost clear IGA score.Tezepelumab (human monoclonal antibody inhibiting TSLP) is an evolving treatment for AD. Etokimab, a selective IL33 inhibitor, showed ~25% were clear/almost clear on the IGA score, but further studies have not gotten far."

Allergic Rhinitis • Asthma • Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • IL5 • TSLP

AnaptysBio Drug Trial Result Disclosures Draw Shareholder Suit (Bloomberg Law) - "AnaptysBio Inc.'s leadership allegedly touted drug trial results without disclosing significant information that made the new product’s future look less rosy, shareholders allege in a new suit filed in a federal court in California."

Corporate lawsuit • Atopic Dermatitis • Dermatology • Immunology

OVERVIEW OF NEW THERAPIES IN AD (ISAD 2021) - "New topical anti-inflammatory agents include the topical phosphodiesterase inhibitor crisaborole and the aryl hydrocarbon receptor agonist tapinarof...The IL-4/ IL-13 receptor blocker dupilumab is a safe and effective treatment option with potential ocular and some on-target side effects, licensed from the age of 6 years...The IL-13-blockers tralokinumab and lebrikizumab target also the Th2 pathway...The IL-31 receptor blocker nemolizumab reduces itch excellently and improves visible lesions, too...Fezakinumab (anti-IL-22), etokimab (anti-IL-33), and tezepelumab (anti-TSLP) have been investigated in smaller proof-of-concept studies for the indication atopic dermatitis. A number of different, fast acting Janus kinase inhibitors, such as Baricitinib, Abrocitinib and Upadacitinib are emerging treatment options differing in efficacy, safety profile and licensing status. Licensed systemic antihistamines (H1R-blockers) only have limited effects on AD related itch and eczema..."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pediatrics • IL13 • IL22 • IL4

Biologics in food allergy: up-to-date. (PubMed, Expert Opin Biol Ther) - "Monoclonal antibodies targeting IgE, the IL-4/IL-13 axis, IL-5, and alarmins have been proposed and investigated for treating food allergy.Expert opinion: The clinical efficacy and safety of biologics have been demonstrated in several preclinical studies and randomized controlled trials. Future studies are still required to address current unmet needs, including the identification of the optimal dose to be used by ensuring the effectiveness of therapy."

Journal • Allergy • Food Hypersensitivity • Immunology • IL13 • IL4 • IL5

AnaptysBio Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Pipeline Updates (Streetinsider.com) - P2, N=100; ECLIPSE (NCT03614923); Sponsor: AnaptysBio, Inc.; "We discontinued further development of etokimab, our anti-IL-33 antibody previously referred to as ANB020, following review of topline week 16 data from the approximately 100-patient ECLIPSE trial in chronic rhinosinusitis with nasal polyps (CRSwNP), where patients dosed with etokimab every four (q4w) or eight weeks (q8w) failed to achieve statistically significant over placebo on either co-primary endpoint."

Discontinued • P2 data • Immunology

Etokimab in Adult Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (clinicaltrials.gov) - P2; N=105; Completed; Sponsor: AnaptysBio, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis