A Study of CDX-622 in Participants With Mild to Moderate Asthma

CDX-622 is a bispecific antibody that binds to stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP). Eligible participants with mild to moderate asthma will receive a single dose of CDX-622 via IV infusion. Additional follow-up visits will be required through EOS (week 12).

Key Inclusion Criteria:

• Males and females, ≥ 18 years of age
• Diagnosis of mild to moderate asthma for at least 12 months
• Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal
• Airway reversibility ≥ 12% and 200 mL improvement in FEV1
• Both males and females of child-bearing potential must agree to use contraception during the study and for 150 days after treatment
• Willing and able to comply with all study requirements and procedures

Key Exclusion Criteria:

• Females who are pregnant or nursing
• Pulmonary disease other than asthma
• Systemic diseases with elevated eosinophils other than asthma
• Hospitalization for treatment of asthma in the past 12 months or required oral corticosteroids due to asthma within the past 6 months
• History of needing ventilator support due to asthma
• Current nasal polyps
• Severe or uncontrolled asthma
• History of smoking or vaping within the past 6 months
• Tuberculosis, hepatitis B or C virus, or HIV
• Immunomodulating biologic therapies within the past 3 months for non-extended half-life biologics.
• Prior receipt of TSLP or KIT inhibitors such as tezepelumab or briquilimab

Additional protocol defined inclusion and exclusion criteria could apply.