Tezspire (tezepelumab-ekko) / AstraZeneca, Amgen - LARVOL DELTA

WAYPOINT: Are we there yet for patients with nasal polyposis? (PubMed, Med) - "The WAYPOINT trial demonstrated that tezepelumab treatment for chronic sinusitis with nasal polyposis was associated with statistically significant and clinically meaningful reductions vs. placebo in both objective (nasal polyp score and rates of rescue steroids or surgery) and subjective (nasal congestion, loss of smell, and sinonasal outcomes test scores) measures of disease burden at 52 weeks.1."

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

AI-Guided Design and Development of HXN-1011: A Potent Anti-TSLP Biparatopic Antibody (EAACI 2025) - "Results Epitope mapping confirmed that HXN-1011 simultaneously binds to both Site I and Site II, while other TSLP antibodies, including Tezepelumab (AstraZeneca), GSK5784283 (GSK/Hengrui), and CM326 (Keymed), bind only to Site I. HXN-1011 exhibited a binding affinity approximately 100-fold higher than Tezepelumab and achieved IC90 values 15- to 100-fold lower in functional assays...HXN-1011 also showed superior efficacy across all tested parameters in OVA+MC903-induced lung and skin inflammation...Conclusion HXN-1011 is a next-generation biparatopic antibody with exceptional potency and significant potential to improve clinical efficacy in treating TSLP-driven inflammatory diseases, such as asthma, COPD, and beyond. Preclinical studies and IND-enabling research for HXN-1011 are currently in progress."

Late-breaking abstract • Dermatitis • Immunology • Inflammation • CRLF2 • IL7R • STAT5 • STAT5AWqe • TSLP

Oscillometry and spirometry derived ratios to assess small airways dysfunction in severe asthma patients taking tezepelumab (EAACI 2025) - "Furthermore, SRM were greater for oscillometry derived ratios compared to spirometry and as such are more likely to detect a meaningful response to tezepelumab in severe asthma. Minimal clinically important differences for oscillometry ratios need to be established."

Clinical • Allergy • Immunology

Worse airflow obstruction but not type 2 biomarkers identifies super-responders to tezepelumab in a real life clinic setting (EAACI 2025) - "Conclusion Worse airflow obstruction but not type 2 biomarkers identified subsequent super-responders to tezepelumab in a real life clinic setting. Longer term follow up will be required to assess if these relationships also apply to clinical remission."

Biomarker • Clinical • Allergy • Immunology

Worse airflow obstruction but not type 2 biomarkers identifies super-responders to tezepelumab in a real life clinic setting (EAACI 2025) - "Conclusion Worse airflow obstruction but not type 2 biomarkers identified subsequent super-responders to tezepelumab in a real life clinic setting. Longer term follow up will be required to assess if these relationships also apply to clinical remission."

Biomarker • Clinical • Late-breaking abstract • Immunology

Oscillometry and spirometry derived ratios to assess small airways dysfunction in severe asthma patients taking tezepelumab (EAACI 2025) - "Furthermore, SRM were greater for oscillometry derived ratios compared to spirometry and as such are more likely to detect a meaningful response to tezepelumab in severe asthma. Minimal clinically important differences for oscillometry ratios need to be established."

Clinical • Late-breaking abstract • Immunology

A promising alternative to monoclonal antibody therapy for the treatment of severe Asthma – a Capsid virus-like particle-based vaccine displaying AI-generated TSLP antigens (EAACI 2025) - "Furthermore, we found that the vaccine-induced antibody response could compete with Tezepelumab for binding to human lfTSLP, verifying the induction of disease-specific neutralizing antibodies. Conclusion These results demonstrate that a cVLP-based vaccine targeting the N-terminal region of lfTSLP holds potential as an alternative to mAb treatment for patients with severe asthma."

Late-breaking abstract • Atopic Dermatitis • Dermatitis • Immunology • Inflammation • IL2 • TSLP

Bispecific Antibody Targeting IL-33 and TSLP for Treating Asthma and COPD (EAACI 2025) - "These antibodies demonstrated significantly enhanced activity compared to Tezepelumab in functional assays. Additionally, a series of anti-IL-33 antibodies were developed with superior potency relative to Itepekimab, as shown by IL-33 reporter assays and PBMC activation assays...Conclusion HXN-1013 is a bsAb designed to simultaneously block both TSLP and IL-33, with each arm exhibiting activity comparable to the parent antibodies. HXN-1013 has the potential to deliver more robust therapeutic effects, offering significant promise for improving clinical efficacy in the treatment of asthma and COPD."

Late-breaking abstract • Immunology • Inflammation • CRLF2 • IL13 • IL33 • IL5 • STAT5 • STAT5AWqe • TSLP

Biological therapy in severe asthma: 20 years of experience at the Hospital Universitario de Burgos (EAACI 2025) - "A total of 54 biologic therapies were prescribed: Omalizumab (78%), Dupilumab (11%), Mepolizumab (7%), and Tezepelumab (4%). The use of these therapies has progressively increased, with Omalizumab being the most widely used due to its early availability. However, the arrival of new biologics expands therapeutic options, and their use is expected to rise, enabling more personalized and effective treatment approaches."

Clinical • Late-breaking abstract • Immunology

A real-world study of tezepelumab in severe asthmatics of a French cohort (EAACI 2025) - "After 12 months, a greater reduction in annual exacerbations and a significant reduction of FeNO were observed. Further studies are needed to identify predictive factors of response."

Clinical • Real-world • Real-world evidence • Immunology

In silico system pharmacology modeling provides insights into a mechanism for greater potency of TSLP/TSLPR pathway inhibition with verekitug, a novel antibody antagonist of TSLPR, as compared to tezepelumab (EAACI 2025) - "Conclusion The semi-mechanistic PK/PD modeling using clinical pharmacodynamic data, model assumptions and parameterization, provides a mechanistic understanding for the observed greater potency of targeting TSLPR with verekitug as compared to the ligand. Whether this difference in potency translates into augmented clinical efficacy with verekitug is currently under investigation."

Immunology • CRLF2 • TSLP

Early Real-World Outcomes of Tezepelumab in Severe Asthma Patients Unresponsive to Prior Biologics (EAACI 2025) - "These outcomes were consistent across different asthma phenotypes and in the presence of comorbid NERD. Further long-term studies are needed to confirm these findings in real-world settings."

Clinical • Real-world • Real-world evidence • Immunology • TSLP

Real-life experience with tezepelumab in severe allergic asthma (EAACI 2025) - "Conclusion In the case of patients who have worse clinical predictors before starting treatment, they have an improvement in the most relevant parameters that start from less severe values. Significant results are evident between 3 and 6 months of treatment."

Clinical • Allergy • Immunology • TSLP

Clinical Effectiveness of Tezepelumab on Upper and Lower Airway Symptoms in Patients with Asthma and Co-morbid Nasal Polyposis (EAACI 2025) - "Conclusion In a real-world cohort of SA patients, tezepelumab led to significantly improved sinonasal symptom scores in patients with co-morbid CRSwNP. In addition, the effectiveness with regards to SA outcomes was significantly greater in this subgroup, highlighting TSLP as an important therapeutic target for SA patients with co-morbid CRSwNP."

Clinical • Immunology • IL5

Md (EAACI 2025) - "She was on therapy with ICS-LABA 2 puffs BD and as needed (MART) and LAMA 2 puffs OD for her asthma; and with methotrexate 20 mg weekly and methylprednisolone 12-20 mg daily for GPA...Results The patient was initiated on anti-TSLP monoclonal antibody tezepelumab, which significantly improved her asthma control, and resulted in FEV1 increase (71% predicted) and ACT score (20 points)...Conclusions We achieved the primary endpoints,treatment with anti-TSLP Ab improved asthma control and patient's quality of life. There is a need for future research to establish whether biological molecules for asthma treatment are also effective for treating various other immunological diseases."

Immunology • Vasculitis • LAMA2

Tezepelumab reduces OCS use and improves sino-nasal symptoms in OCS-dependent patients with severe asthma and comorbid chronic rhinosinusitis (overall and with nasal polyps): results from the phase 3b WAYFINDER study (EAACI 2025) - P3 | "Method WAYFINDER was an open-label, single-arm, OCS-sparing study in adults with severe asthma (across baseline blood eosinophil counts) receiving mOCS (prednisone/prednisolone 5–40 mg/day or equivalent) for ≥ 3 months before study entry. Conclusion Tezepelumab enabled patients with severe asthma and CRS (with or without NP) to reduce or discontinue their mOCS use, while improving sino-nasal symptoms. These data contribute to the growing evidence of the efficacy of tezepelumab in patients with CRS, including CRSwNP."

Clinical • P3 data • Immunology

Real-life experience after 6 months with Tezepelumab in specialized asthma units across northern Spain (EAACI 2025) - "Conclusion These results, observed in this real-world cohort, confirm that the benefits reported in clinical trials are also replicable in uncontrolled clinical settings. The contribution of this study is the significant improvement in SNOT-22 scores at six months of treatment (p = 0.001)."

Clinical • Immunology • TSLP

Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps overall and in patients with and without co-morbid asthma: results from the phase 3 WAYPOINT study (EAACI 2025) - P3 | "Improvements in NPS and NCS were also seen in those with comorbid asthma. Tezepelumab significantly reduced the need for NP surgery or SCS versus placebo in the overall severe CRSwNP population."

Clinical • P3 data • Immunology

Baseline characteristics and main clinical outcomes of patients receiving tezepelumab in the framework of use in Special Situations prior to commercialization in Spain (T-ROSS Study) (EAACI 2025) - "During follow-up, only 30.36% were severe exacerbations, the mean (SD) of predicted pre-BD FEV 1 was 68.87 (19.53) and ACT score mean (SD) was 15.71 (5.89). Conclusion In severe uncontrolled asthma patients who participated in the FMS program (patients that were not eligible to receive any of the approved biologics in Spain or with insufficient response or intolerance to these commercialized biologics), patients treated with tezepelumab reduced exacerbations while increased pulmonary function and asthma control, these findings indicate that clinically meaningful benefits of tezepelumab shown in randomized clinical studies translate into real-life practice."

Clinical • Clinical data • Immunology

Effectiveness of Tezepelumab in uncontrolled severe asthma. ADVANCAT (Advancing severe asthma care with Tezepelumab in Catalonia) (EAACI 2025) - "Conclusion The initial results of this multicenter Catalan study suggest that tezepelumab provides a rapid and sustained clinical improvement in patients with severe asthma regardless of phenotype. This registry of severe asthma in real life will allow us to delve deeper into long-term impact of tezepelumab, not only in conventional clinical variables, but also in novel biomarkers such as imaging."

Immunology • TSLP

Advancements in Biologic Therapies for Pediatric Asthma: Emerging Therapies and Future Directions. (PubMed, Cureus) - "Biologics such as omalizumab, mepolizumab, dupilumab, benralizumab, and tezepelumab have been reported to reduce severe asthma exacerbations, with reassuring short-term safety profiles among children and adolescents (pediatrics)...Literature review also highlights the emerging treatment regimens for non-T2 endotypes, such as tezepelumab, ecleralimab, and astegolimab (IL-33), which influence both T2 and non-T2 pathways...Ultimately, the continued advancement and strategic implementation of biologic therapies hold the potential to revolutionize the management of severe pediatric asthma, leading to reduced exacerbations and corticosteroid use, improved quality of life, and more precise treatment strategies tailored to individual patient profiles. Moreover, future research should continue to address the challenges related to long-term safety, cost-effectiveness, and equitable access, which are vital to realizing the true potential of biologic therapies in treating pediatric..."

Journal • Review • Asthma • Immunology • Inflammation • Pediatrics • Pulmonary Disease • Respiratory Diseases • IL33

Clinical characteristics associated with frequent asthma exacerbations whilst on treatment with tezepelumab (ERS 2025) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

Mechanisms and Treatment of Type 2 High and Low Asthma Endotypes. (PubMed, Clin Exp Allergy) - "Approved biologics for asthma management include using various interleukin antagonists and anti-immunoglobulin E, with Tezepelumab offering promising treatments for both type-2 high and type-2 low asthma patients. Novel therapeutic candidates, such as Itepekimab and depemokimab, have demonstrated promising results in a Phase 2 clinical trial in moderate-to-severe asthma patients."

Journal • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy of tezepelumab in adults with severe, uncontrolled chronic rhinosinusitis with nasal polyps and comorbid NSAID-exacerbated respiratory disease (WAYPOINT) (ERS 2025) - No abstract available

Clinical • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Tezepelumab in Uncontrolled Severe Asthma: A 3-Month Study on Small Airway Function and Symptom Control (ERS 2025) - No abstract available

Asthma • Immunology • Respiratory Diseases