Generate Biomedicines, Inc. · NASDAQ:GENB
Generate Biomedicines — ERS Congress 2025 (Late Breaker)
11 slides from Generate Biomedicines's conference presentation, 2025
Slide 1: GB-0895, a high-affinity anti-TSLP mAb, demonstrates prolonged half-life supporting every 6-month dosing in asthma
GB-0895, a high-affinity anti-TSLP mAb, demonstrates prolonged half-life and sustained pharmacological activity supporting every 6-month dosing in asthma Dave Singh¹, Victoria Szenes², Andreas Eich³, Brian Leaker⁴, Philipp Badorrek⁵, Stanislav Ignatenko⁶, Annelize Koch⁷, Denisa Wilkes⁸, Trisha Shamp
Slide 2: Conflict of interest disclosure
Conflict of interest disclosure I have the following real or perceived conflicts of interest that relate to this presentation: Received sponsorship to attend and speak at international meetings, honoraria for lecturing or attending advisory boards from the following companies: Adovate, Almirall, Ana
Slide 3: Aims of Study
Aims of Study ▪ Thymic stromal lymphopoietin (TSLP) is a validated target in asthma that drives lung inflammation ▪ Generate:Biomedicines developed GB-0895, a next generation, anti-TSLP mAb with – ~20-fold higher affinity for TSLP compared to tezepelumab – YTE Fc modifications for extended half-life
Slide 4: GB-0895 Phase 1, Double Blind, Placebo-Controlled Clinical Trial in Mild-to-Moderate Asthma Patients
GB-0895 Phase 1, Double Blind, Placebo-Controlled Clinical Trial in Mild-to-Moderate Asthma Patients ▪ Mild-to-moderate asthma patients Part A: Single-ascending dose (SAD) | N=80 ▪ Subcutaneous administration Cohort A6 ▪ Sentinels 1:1 randomization; Cohort Remainder 3:1 randomization A5 1200 mg ▪ Bl
Slide 5: Baseline characteristics are consistent across cohorts of our Ph 1 study
Baseline characteristics are consistent across cohorts of our Ph 1 study Cohort A1 Cohort A2 Cohort A3 Cohort A4 Cohort A5 Cohort A6 Total 10mg 30mg 100mg 300mg 600mg 1200mg (N=80) (N=10) (N=10) (N=18) (N=18) (N=14) (N=10) Age, years 40 (12) 42 (12) 40 (13) 41 (13) 36 (13) 41 (11) 40 (13) Mean (SD)
Slide 6: GB-0895 has been well-tolerated
GB-0895 has been well-tolerated Safety data are summarized by blinded cohorts including active and placebo subjects ▪ 80 subjects received a single dose of GB-0895 or placebo; followed ≥ 26 weeks ▪ Most common TEAEs by PT (≥10% incidence in all treatment groups): nasopharyngitis, rhinitis, headache
Slide 7: Clinical PK data for GB-0895 show half-life of ~89 days
Clinical PK data for GB-0895 show half-life of ~89 days Cohort A1: 10mg (N=7) GB-0895 serum concentration Cohort A2: 30mg (N=7) Cohort A3: 100mg (N=13) Cohort A4: 300mg (N=13) Cohort A5: 600mg (N=9) (ng/mL) Cohort A6: 1200mg (N=7) ▪ Dose proportional PK ▪ No evidence of target mediated drug disposit
Slide 8: GB-0895 leads to sustained reductions in blood eosinophils for 6 months
A single subcutaneous administration of GB-0895 leads to sustained reductions in blood eosinophils for 6 months at 100-1200 mg doses Blood Eosinophils Placebo (Pooled, N=23) GB-0895 100mg (N=13) GB-0895 300mg (N=13) Fold Ratio from Baseline GB-0895 600mg (N=10) GB-0895 1200mg (N=7) Visit (Months) Da
Slide 9: GB-0895 leads to sustained reductions in FeNO for 6 months
A single subcutaneous administration of GB-0895 leads to sustained reductions in FeNO for 6 months at 100-1200 mg doses FeNO (PPB) Placebo (Pooled, N=23) GB-0895 100mg (N=13) Mean Change from Baseline GB-0895 300mg (N=13) GB-0895 600mg (N=10) GB-0895 1200mg (N=7) Visit (Months) Data presented is mea
Slide 10: GB-0895 leads to sustained reductions in IL-13 and IL-5 for 6 months
A single subcutaneous administration of GB-0895 leads to sustained reductions in IL-13 and IL-5 for 6 months at 100-1200 mg doses IL-13 IL-5 Placebo (Pooled, N=23) GB-0895 100mg (N=13) GB-0895 300mg (N=13) Fold Ratio from Baseline Fold Ratio from Baseline GB-0895 600mg (N=10) GB-0895 1200mg (N=7) Vi
Slide 11: Conclusions
Conclusions ▪ GB-0895 has been well tolerated ▪ GB-0895 demonstrates dose-proportional pharmacokinetics with a half-life of ~89 days ▪ A single subcutaneous dose provides 6 months of pharmacologic activity, as evidenced by reductions in EOS, FeNO, IL-5, and IL-13 ▪ Broad anti-inflammatory activity o
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