Drug intelligence / Profile preview

GI-101

Development stage
Phase 2
Lead developer
GI Innovation
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration
Parenteral (intravenous)
01

Overview

GI-101 is a novel bispecific recombinant fusion protein designed for cancer immunotherapy. It consists of the extracellular domain of cluster of differentiation 80 (CD80) fused to an interleukin-2 variant (IL-2v), both conjugated with a human IgG4 Fc fragment. The drug is engineered to stimulate immune cell proliferation and activation, particularly cytotoxic T lymphocytes and natural killer (NK) cells, by engaging both the CD28 co-stimulatory pathway and IL-2 receptor signaling. This dual mechanism aims to enhance anti-tumor immunity while potentially overcoming resistance seen with standard PD-1/PD-L1 checkpoint inhibitors. GI-101 is being developed primarily for advanced solid tumors and hematological malignancies as monotherapy or in combination with other agents such as pembrolizumab, lenvatinib, or radiotherapy[1][3][4][5][6][7][8].

02

Targets

IL2RB (IL-2 receptor beta chain)CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)CD28 (Cluster of Differentiation 28)

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