SystImmune Gains FDA IND Clearance for Bispecific Antibody SI-B037
核心洞察
The FDA has cleared SystImmune (搜索)'s Investigational New Drug application for SI-B037 (搜索), a bispecific antibody designed to target immunosuppression and other synergistic mechanisms.
The clearance is SystImmune (搜索)'s first IND supported by New Approach Methodologies, using human organ-on-chip systems and primary human tissue models instead of conventional animal toxicology studies.
SystImmune (搜索) plans to initiate a Phase 1/1b trial of SI-B037 (搜索) in patients with advanced solid tumors (搜索) refractory to standard therapies, evaluating dosing and clinical activity.
SystImmune (搜索) Inc. said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for SI-B037 (搜索), a bispecific antibody targeting immunosuppression and other synergistic mechanisms. The Redmond, Washington-based clinical-stage company develops multi-specific antibodies and antibody-drug conjugates.
The clearance is SystImmune (搜索)'s first IND application built on New Approach Methodologies (NAMs) as part of its integrated nonclinical safety and translational assessment package. The company said the package used human organ-on-chip systems and primary human tissue models in place of conventional animal toxicology studies, a shift toward non-animal testing alternatives that regulators worldwide have encouraged.
SystImmune (搜索) said it intends to begin a Phase 1/1b trial of SI-B037 (搜索) to determine optimal dosing and characterize clinical activity in patients with advanced solid tumors (搜索) refractory to standard therapies. The company added that it will continue working with regulatory agencies to refine translational endpoints and human-relevant safety models in future studies.
Source: PR Newswire