Generate:Biomedicines to Present Phase 1 Results for AI-Engineered GB-0895 in Asthma at the European Respiratory Society International Congress

GB-0895, a next-generation, ultra-high affinity anti-TSLP monoclonal antibody, demonstrated prolonged half-life and sustained pharmacology in asthma patients

GB-0895 is optimized for a single subcutaneous injection every six months

SOMERVILLE, Mass., Sept. 25, 2025 /PRNewswire/ -- Generate:Biomedicines ("Generate") today announced that results from its Phase 1 study of GB-0895 will be presented as a late-breaker at the European Respiratory Society International Congress in Amsterdam on September 28, 2025. GB-0895 is an investigational, subcutaneously administered anti–thymic stromal lymphopoietin (TSLP) antibody engineered with generative AI for the treatment of multiple respiratory diseases.

In the Phase 1 study, 96 patients with mild to moderate asthma and blood eosinophil counts ≥150 cells/µL were dosed in single ascending dose (Part A) and multiple ascending dose (Part B) cohorts. Results from Part A will be presented. GB-0895 was well tolerated across a wide dose range of 10 mg to 1200 mg and demonstrated dose-proportional pharmacokinetics with a prolonged half-life of ~89 days. Sustained reductions in eosinophils, FeNO, IL-5, and IL-13 were observed for at least six months, consistent with an anti-TSLP mechanism of action. These data support the potential for an every six-month regimen.

"Generative biology is moving drug discovery from a process of chance to one of design," said Mike Nally, chief executive officer of Generate:Biomedicines. "GB-0895 was engineered with our generative biology platform and optimized to reduce the treatment burden patients face today. The Phase 1 results are an important proof point and demonstrate progress on our path toward later-stage trials."

"GB-0895 could provide an important treatment alternative for patients with respiratory diseases, including severe asthma, building on the established benefit-risk profile associated with an anti-TSLP mechanism of action," said Professor Dave Singh, MD, Professor of Clinical Pharmacology & Respiratory Medicine at the University of Manchester, Medical Director at the Medicines Evaluation Unit in Manchester, and principal investigator of the Phase 1 study. "GB-0895 has the potential to offer the convenience of a single subcutaneous injection every six months."

European Respiratory Society International Congress presentation details

• Date/Location: 15:45–17:00, September 28, 2025, Amsterdam, the Netherlands
• Session: Cutting-edge trial data on biologic for airway diseases: asthma, COPD, chronic rhinosinusitis with nasal polyps and chronic cough
• Presentation Title: GB-0895, a high-affinity anti-TSLP mAb, demonstrates prolonged half-life and sustained pharmacological activity supporting every 6-month dosing in asthma
• Presenter: Dr. Dave Singh
• Abstract: View on ERS Congress website

About GB-0895
GB-0895 was designed with Generate:Biomedicines' generative biology platform, which integrates proprietary machine-learning models with high-throughput experimentation. GB-0895 was engineered to block thymic stromal lymphopoietin (TSLP), an epithelial cell-derived cytokine that helps initiate and amplify airway inflammation in asthma. Using a generative optimization technology stack, GB-0895 was computationally designed to improve potency and half-life while retaining specificity. Patent No. 12,110,324 has been issued by the U.S. Patent and Trademark Office.

About Generate:Biomedicines  
Generate:Biomedicines is a technology company founded at the intersection of machine learning, biological engineering, and medicine that is advancing a new era of programmable biology to engineer better medicines for patients, faster. The Generate Platform's infusion of technology into biology allows us to address historically undruggable and hard-to-drug targets as well as known targets in new and more effective ways. The platform has enabled the generation of a broad pipeline of therapies across multiple therapeutic areas and protein-based modalities, addressing health challenges out of reach of traditional approaches. Founded by Flagship Pioneering in 2018, Generate is a clinical-stage company leading a fundamental shift from drug discovery to drug generation. Learn more at www.generatebiomedicines.com or follow us on X, LinkedIn, and YouTube.

Generate Media Contact   
Megan McLaughlin 
[email protected]   

SOURCE Generate:Biomedicines