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

Prior treatment

• For cohorts receiving E-602 and cemiplimab combination therapy:
  • Prior moderate or severe hypersensitivity to cemiplimab or its formulation
  • 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.
  • 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.
  • Previously received idelalisib.
• Recent surgery, treatment with another investigational agent, active infection, non-healing wound or uncontrolled bleeding/bleeding diathesis.
• Received a vaccine or prior radiotherapy within 14 days prior to Cycle 1 Day 1.
• 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.
• Subject is taking the equivalent of \>10 mg/day oral prednisone or on systemic immunosuppressive therapy.
• Subject has had an allogeneic tissue or organ transplantation.

Other illness

• A known primary malignancy that is progressing or has required active treatment within the past 3 years.
• History of thromboembolic event unless the event occurred \> 6 months from Cycle 1 Day 1 and the subject is on anti-coagulation treatment.

Age

• History of age-related macular degeneration (AMD).

Other

• Untreated brain metastases.

• Subjects with advanced or relapsed/refractory melanoma, ovarian cancer, NSCLC, colorectal cancer, pancreatic cancer, breast cancer, gastric/esophagogastric junction (EGJ) cancer, head and neck cancer, or urothelial cancer who have failed prior therapies.
  • Subjects with melanoma, NSCLC, head and neck cancer, urothelial cancer, or mMSI-H or dMMR colorectal cancer must have had prior anti-PD-(L)1 pathway therapy and been deemed resistant (had progression on therapy or within 3 months of discontinuation of therapy).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subject has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
• Adequate bone marrow, coagulation, renal function, and liver function as determined by laboratory tests