Biogen (BIIB) Piper Sandler Virtual Novel Targets in Immunology Symposium summary

Strategic focus and pipeline overview

• Prioritizing lupus due to its heterogeneity and major unmet need, with two decades of experience in the field.

• Advancing dapirolizumab and litifilimab in late-stage development for SLE and CLE, leveraging deep biological insights.

• Emphasizing the need for multiple advanced treatment options due to disease variability and patient-specific manifestations.

• Highlighting a broad immunology pipeline, including early-stage assets and plans to expand into oral therapies.

Clinical development and trial design

• Litifilimab targets BDCA2 on plasmacytoid dendritic cells, aiming to disrupt interferon-driven inflammation in SLE and CLE.

• Demonstrated efficacy in joint and skin manifestations, with breakthrough designation for CLE.

• Trials use different primary endpoints (SRI-4 for litifilimab, BICLA for dapirolizumab) based on proof-of-concept signals, with both endpoints measured in each study.

• CLE trials focus on speed of symptom resolution, with primary endpoints at 24 weeks and durability assessed at 52 weeks.

Differentiation, safety, and future landscape

• Dapirolizumab enables significant steroid tapering, with up to a fifth of patients reducing to low-dose steroids.

• Preclinical data suggest dapirolizumab does not cross the placenta or enter breast milk, potentially allowing safe use in pregnancy and postpartum.

• Anticipates a more varied treatment landscape as new oral agents approach phase III readouts, with a focus on combination and sequential therapies.