quilizumab (MEMP1972A) / Roche - LARVOL DELTA

Q-CAR: A first-in-class therapy selectively targeting IgE-producing cells for treatment of severe allergic disease (ASGCT 2026) - "The CAR (“Q-CAR”) antigen binding domain was derived from the anti-IgE monoclonal antibody quilizumab...The consistent and complete killing of primary human IgE-secreting cells across multiple donors demonstrates the strength of this approach in eradicating IgE production. Together with data from mouse models demonstrating the ability to kill circulating and tissue-resident IgE+ cells, these findings establish a proof of principle for CAR-T technology in allergic disease and support the development of Q-CAR as a potentially curative treatments for severe IgE- mediated disorders."

Allergy • Asthma • Chronic Spontaneous Urticaria • Food Hypersensitivity • Respiratory Diseases • Urticaria

Evidence-Based Information on Newer Drugs for Chronic Spontaneous Urticaria (AAD 2026) - " Bruton Tyrosine Kinase inhibitors, remibrutinib and fenebrutinib, are fast-acting, oral medications with a favorable safety and efficacy in CSU and greater potency in type IIb autoimmune urticaria...Quilizumab, canakinumab, Tezepelumab, and benralizumab are not beneficial in CSU. BTK inhibitors are efficacious in CSU and may be superior to omalizumab for type IIb autoimmune urticaria, where disease control is often delayed and limited with anti-IgE agents. Ligelizumab and dupilumab are safe and effective alternatives to omalizumab for anti-histamine-resistant CSU."

Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • IL4 • IL4R

Novel CAR-based Cellular Therapy Targeting Membrane-bound Immunoglobulin E (EHA-EBMT-CART 2026) - "We developed a quilizumab-derived CAR (Q-CAR), a construct based on an evaluated monoclonal antibody (mAb), that targets M1 prime segment (part of extracellular membrane-proximal domain, EMPD) of a membrane-bound IgE (mIgE)...Furthermore, we compared the cytotoxic abilities of T cells expressing either Q- or anti-CD19- CAR, confirming they were capable of killing Ramos-EMPD cells. Conclusions : We report the development of a novel Q-CAR that directs effector cells to specifically recognise and eliminate cells expressing membrane-bound IgE for potential application in IgE-mediated disorders."

Asthma • CNS Disorders • Immunology • Inflammatory Arthritis • Lupus • Myasthenia Gravis • Respiratory Diseases • Systemic Lupus Erythematosus • Urticaria

CAR-T cells targeting the human IgE-B-cell-receptor specifically abolish IgE production by human B cells and eliminate IgE+ cells in vivo (ESGCT 2024) - "To specifically target IgE expressing B cells, Genentech has developed the monoclonal antibody (mAb) Quilizumab...Since mice do not express the M1` domain we designed transgenic mice in which the murine extra membranal proximal domain (EMPD) is replaced by the human one. Q-CAR-T cells targeting membrane bound IgE are thus envisioned as a curative therapy for IgE mediated allergies, providing sustained surveillance against IgE B cell resurgence and relieving the patient from all atopic diseases."

CAR T-Cell Therapy • Preclinical • Asthma • Hematological Malignancies • Immunology • Leukemia • Respiratory Diseases

Addressing the Unmet Need in Chronic Spontaneous Urticaria: A Network Meta-Analysis of Novel and Established Therapies (EADV 2025) - "Interventions: Oral agents: Cyclosporine, fenebrutinib, hydroxychloroquine, methotrexate, remibrutinib. Subcutaneous agents: Barzolvolimab, benralizumab, dupilumab, ligelizumab, omalizumab, quilizumab, tezepelumab...Efficacy: i. All treatments except benralizumab, methotrexate, and quilizumab significantly improved UAS7, ISS7, HSS7, and DLQI vs. placebo... 1. Barzolvolimab is the most effective therapy for symptom control (UAS7/HSS7/ISS7). 2."

Retrospective data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Comparative efficacy and safety of biologics and systemic immunomodulatory treatments for chronic urticaria: Systematic review and network meta-analysis. (PubMed, J Allergy Clin Immunol) - "Among individuals with chronic urticaria refractory to antihistamines, standard-dose omalizumab and remibrutinib are among the most effective drugs across multiple patient-important outcomes with a favorable safety profile across the studied duration. Cyclosporine may be effective but may be among the most harmful. Dupilumab improves itch and wheals, but it is uncertain whether it improves angioedema or quality of life. Lower doses of omalizumab are of intermediate effectiveness and favorable safety. The net benefit of conventional immunosuppressants is uncertain."

Journal • Retrospective data • Cardiovascular • Dermatology • Immunology • Urticaria

Chimeric Antigen Receptor T Cells Targeting the IgE B Cell Receptor Specifically Eliminate Human IgE Producing B cells (ASGCT 2025) - "Our "Q CAR" construct, derived from the monoclonal antibody Quilizumab, demonstrated robust cytotoxicity against primary human IgE-secreting cells and significantly reduced IgE production in vitro...Our findings pave the way for further investigation in transgenic allergy models, with the ultimate goal of clinical translation to offer curative solutions for IgE-mediated disorders. Disease Focus of Abstract:Other Other: IgE mediated diseases"

CAR T-Cell Therapy • Asthma • Dermatology • Immunology • Oncology • Respiratory Diseases • Urticaria

Chimeric Antigen Receptor T Cells Targeting IgE B Cell Receptor Successfully Eliminate IgE-B Cells and Specifically Abolish IgE Production In Vitro (ASGCT 2024) - "In order to specifically target IgE expressing B cells, rather than free IgE, Genentech has developed the monoclonal antibody (mAb) Quilizumab...This therapeutic approach has been shown to be very successful against hematologic cancers , and we hope that it will do the same against allergy. with a single treatment the engineered cells will cure the patient from all his IgE mediated allergies, and by their ability to remain in the body will provide life long cure."

CAR T-Cell Therapy • Preclinical • Allergy • Asthma • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases

Biologics to treat anaphylaxis. (PubMed, Curr Opin Allergy Clin Immunol) - "Anaphylaxis is a potentially life-threatening acute hypersensitivity reaction affecting up to 16.8% of the U.S. population. Acute management entails swift identification, removal of the causative agent, and the prevention of cardiovascular collapse, firstly with epinephrine. Adjunctive treatments such as antihistamines work to prevent anaphylaxis from recurring. Biologic management of anaphylaxis involves the use of large-molecule drugs such as monoclonal antibodies. Omalizumab, an IgG1 monoclonal antibody targeting unbound IgE, is the most prevalent and widely studied biologic in the prevention of anaphylaxis. Other monoclonal antibodies in development or approved for other indications, such as ligelizumab, quilizumab, MEDI4212, and dupilumab, may also have potential for preventing anaphylaxis through various mechanisms."

Journal • Cardiovascular • Immunology

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

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

Anti-IgE for the Treatment of Chronic Urticaria. (PubMed, Immunotargets Ther) - "Phase 2 b results of ligelizumab have not only demonstrated efficacy and safety but also superiority to omalizumab. Whereas further development of quilizumab was discontinued, other approaches, eg UB-221 or DARPins are under investigation. Anti-IgE treatment with omalizumab represents a landmark in the treatment of chronic urticaria, with and without angioedema, and there is light on the horizon suggesting success may come with various next-generation anti-IgE approaches."

Clinical • Journal • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Urticaria

[VIRTUAL] Current and future management of chronic urticaria (WAC 2020) - "In patients unresponsive to antihistamines add on therapy with monoclonal anti-IgE antibodies (Omalizumab) is indicated, and alternatively Cyclosporine could be administered to patients who do not respond to anti-IgE or in cases where this medication is not available, although this immunosuppressor has a less favorable profile of adverse effects than Omalizumab, needing especial attention to the possibility of renal toxicity. They include other monoclonal anti-IgE antibodies such as Ligelizumab and Quilizumab, Intravenous immunoglobulins (IvIg), tumor necrosis factor alpha (TNF-) inhibitors, antiCD20 (Rituximab), IL-1 inhibitors, Syk inhibitors, PGDR2 antagonists, Btk inhibitors, and anti-Siglec-8. Potential and future therapies for refractory chronic urticaria will be discussed in this Symposium."

Dermatology • Urticaria • SYK

Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. (PubMed) - "In subjects with allergic asthma who were subjected to an allergen challenge, quilizumab treatment blocked the generation of new IgE, reduced allergen-induced early and late asthmatic airway responses by 26 and 36%, respectively, and reduced allergen-induced increases in sputum eosinophils by ~50% compared with placebo. These studies indicate that targeting of membrane IgE-expressing cells with anti-M1 prime antibodies can prevent IgE production in humans."

Preclinical • Asthma • Biosimilar • Eczema • Immunology • Inflammation

Roche: HY 2014 Results (Roche) - Anticipated NME submission in US for asthma in 2017 or later; Anticipated NME submission in EU for asthma in 2017 or later

Anticipated BLA • Anticipated EU regulatory • Asthma