Apogee Therapeutics (APGE) Jefferies London Healthcare Conference 2024 summary

Strategic focus and innovation

• Prioritizing APG-777 for atopic dermatitis, aiming for phase II proof-of-concept data in H2 2025, with operational efficiency by integrating phase II-A and II-B into a single trial.

• Exploring combination therapies, notably APG-777 (IL-13) with APG-990 (OX40L), to enhance efficacy and address disease heterogeneity, with more details to be shared at the December R&D day.

• Targeting longer dosing intervals (three to six months) and higher efficacy compared to current biweekly standards in the $50B atopic dermatitis market.

• Pipeline includes expansion into respiratory indications, leveraging validated biology and combination strategies.

• Emphasizing capital efficiency and milestone-driven financing, with flexibility to adapt based on emerging data.

Clinical development and regulatory considerations

• Combination trial designs are informed by safety profiles of monotherapies, aiming to avoid overlapping toxicity and meet regulatory requirements.

• APG-777 monotherapy targets 30%-40% higher exposure than lebrikizumab, aiming for improved efficacy with less frequent dosing.

• Co-formulated combos allow titration of each component, offering flexibility over bispecifics and enabling optimal efficacy and safety.

• Preclinical and clinical data will guide prioritization between TSLP and IL-4 as combination partners, with decisions driven by efficacy and dosing advantages.

• Regulatory engagement and preclinical studies are ongoing to support safe clinical advancement of novel combinations.

Market differentiation and scientific rationale

• OX40L selected as a combination partner due to its demonstrated efficacy and cleaner safety profile compared to OX40, with the goal of achieving JAK-like efficacy without black box warnings.

• Co-formulation preferred over bispecifics for certain targets (e.g., IL-13/OX40L), as bispecifics are not feasible or offer no additive benefit in some indications.

• TSLP and OX40L combinations positioned to address unmet needs in respiratory diseases, especially in low-eosinophil populations.

• Biomarker-driven patient selection is being developed for atopic dermatitis, with ongoing data collection to identify responsive subgroups.

• Flexibility in pipeline allows for adaptation based on scientific and market developments, with a focus on best-in-class dosing and efficacy.