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SystImmune Receives FDA Clearance of IND Application for Bispecific Antibody SI-B037
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Fusion42 · 22 September 2026 · Fusion42 review
The FDA has cleared SystImmune's IND application for SI-B037, a bispecific antibody developed using New Approach Methodologies (NAMs) including human organ-on-chip systems, marking a pioneering step in human-centric nonclinical safety testing and advancing to Phase 1/1b trials.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 22 Sep 2026 and 25 Sep 2026.
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Cancer drug developers must reassess nonclinical safety strategies now that FDA endorsement of human-centric models opens a faster path to first-in-human trials. You can cut reliance on animal tests to pace your IND timelines and gain competitive translational insights.
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2 sources · first reported 22 Sep 2026 · latest 25 Sep 2026
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