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., September 25, 2025 — 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 Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at the University of Manchester and 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 Societ y 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​.gen​er​ate​bio​med​i​cines​.com or follow us on X , LinkedIn , and YouTube . Generate Media Contact Megan McLaughlin, Media Relations Email: pr@​generatebiomedicines.​com

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