On September 22, 2026 SystImmune Inc. (SystImmune), a clinical-stage biotechnology company advancing next-generation multi-specific antibodies and antibody-drug conjugates (ADCs), reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SI-B037, a bispecific antibody targeting immunosuppression and other synergistic mechanisms.
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The FDA clearance marks SystImmune’s first IND application utilizing New Approach Methodologies (NAMs) as part of its integrated nonclinical safety and translational assessment package. It also underscores the company’s role at the forefront of the global paradigm shift toward modern, human-centric, non-animal testing alternatives encouraged by regulatory authorities worldwide.
"We used human organ-on-chip systems and primary human tissue models, in place of conventional animal toxicology studies," said Dr. Jahan Khalili, Senior Vice President of Research at SystImmune. "Human-relevant models gave us a more direct read on a molecule designed to engage multiple human pathways in the nonclinical package, built around New Approach Methodologies."
"Patients with advanced solid tumors refractory to standard therapies remain in urgent need of novel therapeutic options with coordinated mechanisms of action," said Dr. Anand Achanta, Senior Vice President, Regulatory Affairs and Medical Writing. "We look forward to initiating the Phase 1/1b trial to determine optimal dosing and characterize the clinical activity of SI-B037, while continuing to collaborate closely with regulatory agencies to refine translational endpoints and human-relevant safety models in future studies."
(Press release, SystImmune, SEP 22, 2026, View Source [SID1234671006])