OPRX-106

OPRX-106 is an orally administered, plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc). Developed by Protalix BioTherapeutics, it is designed as a nonabsorbable oral anti-TNFα therapy for inflammatory and autoimmune diseases. The drug consists of lyophilized Nicotiana tabacum (BY2) tobacco plant cells expressing the recombinant TNFR2-Fc fusion protein, which acts locally in the gut to modulate immune responses without systemic absorption. Its mechanism involves binding and inhibiting tumor necrosis factor alpha (TNFα), leading to reduced inflammation and favorable immune modulation, including stimulation of regulatory T lymphocytes and reduction of pro-inflammatory cytokines such as interleukin 6 and interferon gamma. Clinical trials demonstrated safety, tolerability, and efficacy in mild-to-moderate ulcerative colitis; however, development has been discontinued for all indications[1][5][6][7].