GB-0895 / Generate Biomedicines - LARVOL DELTA

Late Breaking Abstract - GB-0895, a high-affinity antibody to TSLP, demonstrates potent and sustained pharmacological activity in adults with chronic obstructive pulmonary disease. (ERS 2026) - "Background: GB-0895, with ~20-fold higher affinity for thymic stromal lymphopoietin (TSLP) compared to tezepelumab and an extended half-life, is a next-generation anti-TSLP monoclonal antibody. The duration and magnitude of the broad anti-inflammatory effects were comparable to those in asthma patients, suggesting GB-0895 drives sustained TSLP inhibition in both diseases. GB-0895 was well-tolerated and induced rapid and durable suppression of PD biomarkers in COPD patients, supporting further development of GB-0895 for COPD."

Clinical • Late-breaking abstract • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL13 • IL5 • TSLP

Late Breaking Abstract - SOLAIRIA-1 and SOLAIRIA-2: Two Phase 3, global, randomized, double-blind, placebo-controlled studies of GB-0895, a next-generation long-lasting anti-TSLP antibody, in adults and adolescents with severe uncontrolled asthma (ERS 2026) - P3 | "Background: GB-0895 is a next generation anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody with ~20-fold higher affinity compared with tezepelumab and an extended half-life. A single 300 mg SC injection of GB-0895 drives rapid and durable PD biomarker suppression for at least 6 months, supporting Q6M dosing. These Phase 3 studies are evaluating the potential of GB-0895 Q6M as an adjunctive treatment for severe asthma."

Clinical • Late-breaking abstract • P3 data • Asthma • Immunology • Respiratory Diseases • IL13 • IL5 • TSLP

Late Breaking Abstract - GB-0895, a next-generation anti-TSLP mAb, demonstrates durable pharmacologic activity supporting a single subcutaneous injection every 6 months for asthma patients. (ERS 2026) - "A single 300 mg SC injection of GB-0895 was well tolerated and drives PD biomarker suppression for at least 6 months, comparable to those reported with monthly doses of tezepelumab. These findings support evaluation of GB-0895 Q6M dosing in ongoing Phase 3 asthma studies."

Clinical • Late-breaking abstract • Asthma • Immunology • Respiratory Diseases • IL13 • IL5

Lessons learned from clinical trials of thymic stromal lymphopoietin (TSLP) inhibition. (PubMed, J Allergy Clin Immunol) - "Tezepelumab is currently the only approved anti-TSLP therapy. Other TSLP-targeting agents, including ecleralimab, SHR-1905, bosakitug, verekitug, sunakiment, TAVO101, ocankitug, HBM9378, MG-ZG122, GB-0895, and solrikitug, are in clinical development."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • Urticaria • IL13 • IL5 • TSLP

GB-0895-302: A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma (SOLAIRIA-1) (clinicaltrialsregister.eu) - P2/3 | N=69 | Not yet recruiting | Sponsor: Generate Biomedicines Inc.

New P2/3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

GB-0895-302: A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma (SOLAIRIA-1) (clinicaltrialsregister.eu) - P2/3 | N=57 | Not yet recruiting | Sponsor: Generate Biomedicines Inc.

New P2/3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

GB-0895-301: A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma (SOLAIRIA-1) (clinicaltrialsregister.eu) - P2/3 | N=122 | Not yet recruiting | Sponsor: Generate Biomedicines Inc.

New P2/3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Generate Biomedicines, Inc. Reports First Quarter 2026 Financial Results and Provides Business Update (PRNewswire) - "In inflammation and immunology, Generate's GB-0895 (anti-TSLP) program continues to advance, with Phase 3 clinical trials underway in severe asthma with its global SOLAIRIA-1 and SOLAIRIA-2 replicate studies, and a Phase 1b trial is ongoing in COPD."

Trial status • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

Generate plans $425M IPO to bankroll antibody’s phase 3 asthma trials (FierceBiotech) - "The company has already earmarked $300 million of the IPO funds to complete a pair of phase 3 asthma trials for its anti-TSLP antibody GB-0895, which are expected to enroll about 1,600 patients...Generate expects an additional $100 million will be needed for its ambition to complete an ongoing phase 1b study of GB-0895 for chronic obstructive pulmonary disease and then to 'initiate the next phase of clinical development,' according to the filing."

Financing • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2) (clinicaltrials.gov) - P3 | N=786 | Recruiting | Sponsor: Generate Biomedicines | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1) (clinicaltrials.gov) - P3 | N=786 | Recruiting | Sponsor: Generate Biomedicines | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2) (clinicaltrials.gov) - P3 | N=786 | Not yet recruiting | Sponsor: Generate Biomedicines

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1) (clinicaltrials.gov) - P3 | N=786 | Not yet recruiting | Sponsor: Generate Biomedicines

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Generate:Biomedicines to Initiate Global Phase 3 Studies of GB-0895, a Long-Acting Anti-TSLP Antibody for Severe Asthma Engineered with AI (PRNewswire) - "SOLAIRIA-1 and SOLAIRIA-2 will evaluate GB-0895 in approximately 1,600 patients with severe asthma whose disease remains inadequately controlled on current therapies."

New P3 trial • Asthma • Immunology

Phase 1 Results Presented at ERS 2025 (PRNewswire) - "In this study of 96 people with mild to moderate asthma, GB-0895 was generally well tolerated across a wide dose range (10 mg to 1,200 mg), demonstrated dose-proportional pharmacokinetics with an approximately 89-day half-life, and produced sustained reductions in key biomarkers consistent with blocking TSLP for at least six months."

P1 data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology

A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD (clinicaltrials.gov) - P1 | N=156 | Active, not recruiting | Sponsor: Generate Biomedicines | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - GB-0895, a high-affinity anti-TSLP mAb, demonstrates prolonged half-life and sustained pharmacological activity supporting every 6-month dosing in asthma (ERS 2025) - "A single dose of GB-0895 drives PD biomarker suppression for at least 6 months, reflecting the broad anti-inflammatory effects of the anti-TSLP mechanism seen with tezepelumab. These results support dosing GB-0895 every 6-months for the treatment of severe asthma."

Late-breaking abstract • Asthma • Immunology • Respiratory Diseases • IL13 • IL5

A Study to Investigate GB-0895 in Adults With Mild to Moderate Asthma or COPD (clinicaltrials.gov) - P1 | N=156 | Recruiting | Sponsor: Generate Biomedicines

New P1 trial • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A long-acting high affinity anti-TSLP antibody (GB-0895) for severe asthma identified leveraging a proprietary machine learning platform (ERS 2024) - "The approved anti-TSLP antibody (tezepelumab) requires monthly administration; a longer duration treatment could improve adherence and outcomes. Conclusions GB-0895 has the potential for best-in-class dosing for patients with severe asthma. A phase 1 dose escalation trial in asthma patients is underway."

Machine learning • Asthma • Immunology • Inflammation • Respiratory Diseases