Drug intelligence / Profile preview

GI-101A + pembrolizumab

Development stage
Unknown
Lead developer
GI Innovation
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

GI-101A + pembrolizumab is an investigational combination therapy for advanced and/or metastatic solid tumors. GI-101A is a novel bi-specific Fc fusion protein containing the CD80 ectodomain (N-terminal) and an interleukin-2 (IL-2) variant (C-terminal), joined via a human IgG4 Fc region. This design aims to stimulate the immune system (via IL-2 and CD28 co-stimulation) and block inhibitory pathways (via CD80 binding to CTLA-4), enhancing anti-tumor immunity while aiming to minimize toxicity compared to conventional anti-CTLA-4 therapy. Pembrolizumab is a PD-1–blocking monoclonal antibody (brand name Keytruda) that releases the PD-1–mediated brake on immune cells, thereby enhancing T cell–mediated tumor destruction. The combination intends to provide synergistic efficacy in solid tumors, including cases less responsive to immune checkpoint therapy, such as those with low PD-L1 expression. GI-101A is an improved, more consistent formulation of the original GI-101 protein[1][3][5][7].

Other names
GI-101A plus pembrolizumabGI101A plus pembrolizumabGI 101A plus pembrolizumab
02

Targets

IL-2R (Interleukin-2/interleukin-15 receptor complex)CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)CD28 (Cluster of Differentiation 28)PDCD1 (Programmed cell death protein 1 receptor)

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