FDA Clears IND Application for SystImmune's Bispecific Antibody SI-B037
1 report, 1 independent
Updated Sep 22
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What happened
The U.S. Food and Drug Administration cleared the Investigational New Drug application for SI-B037, a bispecific antibody developed by SystImmune. This clearance is significant because it was the company's first IND application to utilize New Approach Methodologies (NAMs) in its nonclinical safety assessment.
From prnewswire.com
Why it matters
The approval signals a shift toward human-centric, non-animal testing alternatives encouraged by regulatory authorities worldwide. SI-B037 is designed as a novel therapeutic option for patients with advanced solid tumors refractory to standard therapies.
From prnewswire.com
Who's involved
- FDARegulatory agency that cleared the Investigational New Drug application