Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)

Exclusion Criteria

• •1. For cohorts receiving E-602 and cemiplimab combination therapy:
• •1. Prior moderate or severe hypersensitivity to cemiplimab or its formulation
• •2. History of severe (≥ Grade 3) autoimmune complications or discontinuation due to toxicity following treatment with an anti-PD-(L)1 pathway therapy as a monotherapy, with the exception of asymptomatic Grade 3 elevations in lipase and/or amylase not associated with clinical manifestations of pancreatitis.
• •3. Subject has an active autoimmune disease. The following are not exclusionary: vitiligo, type 1 diabetes, autoimmune endocrinopathies that are stable on hormone replacement therapy, or psoriasis that does not require systemic treatment.
• •4. Previously received idelalisib.
• •2. History of age-related macular degeneration (AMD).
• •3. Recent surgery, treatment with another investigational agent, active infection, non-healing wound or uncontrolled bleeding/bleeding diathesis.
• •4. Received a vaccine or prior radiotherapy within 14 days prior to Cycle 1 Day 1.
• •5. Prior history of interstitial lung disease that required steroids or ≥ Grade 2 immune-related pneumonitis or has current non-infectious pneumonitis or interstitial lung disease. Subject has a history of ≥Grade 3 radiation pneumonitis, or Grade 2 radiation pneumonitis that has been active within the last 6 months.
• •6. Untreated brain metastases.
• •7. A known primary malignancy that is progressing or has required active treatment within the past 3 years.
• •8. Subject is taking the equivalent of \>10 mg/day oral prednisone or on systemic immunosuppressive therapy.
• •9. Subject has had an allogeneic tissue or organ transplantation.
• •10. History of thromboembolic event unless the event occurred \> 6 months from Cycle 1 Day 1 and the subject is on anti-coagulation treatment.