Drug intelligence / Profile preview

SYN125 + SYN004

Development stage
Unknown
Lead developer
Theriva Biologics
Modality
Recombinant Proteins and Enzymes, Small Molecules
Administration
Intravenous (SYN125), Oral (SYN004)
01

Overview

SYN125 + SYN004 is an investigational combination therapy evaluated in a clinical trial setting for patients with solid tumors, including epithelial cancers with EGFR mutations. SYN125 is designed to modulate T-cell function and support immune activation against cancer cells. SYN004 (ribaxamase) is an orally administered β-lactamase enzyme that degrades IV β-lactam antibiotics in the gastrointestinal tract, preserving gut microbiome integrity and reducing antibiotic-associated side effects. The combination is hypothesized to enhance anti-tumor immune responses by improving T-cell efficacy (SYN125) and reducing antibiotic-mediated dysbiosis/complications using SYN004[3][6]. Dose escalation trials have evaluated safety, tolerability, and incidence of dose-limiting toxicities for SYN125 alone and in combination with a fixed dose of SYN004[3][6].

Other names
SYN125 + SYN004

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