SystImmune Wins FDA IND Clearance Using Non-Animal Test Methods
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Redmond – September 22, 2026 -- SystImmune Inc. has secured U.S. Food and Drug Administration clearance for its Investigational New Drug application for SI-B037, a bispecific antibody, marking the first time the company has built a regulatory submission entirely on New Approach Methodologies (NAMs) rather than traditional animal toxicology studies.
SystImmune replaces animal testing with human organ-on-chip models
The IND package for SI-B037 relied on human organ-on-chip systems and primary human tissue models instead of conventional animal studies to assess nonclinical safety. Dr. Jahan Khalili, Senior Vice President of Research at SystImmune, said the human-relevant models provided a more direct read on a molecule engineered to engage multiple human pathways simultaneously.