SystImmune Receives FDA Clearance of IND Application for Bispecific Antibody SI-B037
SystImmune Inc., a clinical-stage biotechnology company based in Redmond, Washington, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for SI-B037, a bispecific antibody targeting immunosuppression and other synergistic mechanisms. This marks the company's first IND application that employs New Approach Methodologies (NAMs), which are part of its integrated nonclinical safety and translational assessment package.
The FDA's approval highlights SystImmune's commitment to advancing modern testing methods that prioritize human-centric, non-animal alternatives, a shift supported by regulatory authorities globally. "We used human organ-on-chip systems and primary human tissue models, in place of conventional animal toxicology studies," stated 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."
Dr. Anand Achanta, Senior Vice President of Regulatory Affairs and Medical Writing, emphasized the urgency for new treatment options, stating, "Patients with advanced solid tumors refractory to standard therapies remain in urgent need of novel therapeutic options with coordinated mechanisms of action." The company plans to initiate a Phase 1/1b trial to establish optimal dosing and assess the clinical activity of SI-B037, while working closely with regulatory agencies to enhance translational endpoints and safety models in future studies.
SystImmune specializes in the development of innovative cancer treatments, focusing on bispecific and multi-specific antibodies, as well as antibody-drug conjugates (ADCs). The company is involved in several clinical trials for both solid tumor and hematologic indications and maintains a robust preclinical pipeline of potential cancer therapeutics in various stages of development.
The release also contains forward-looking statements concerning the initiation and design of the Phase 1/1b clinical trial of SI-B037 and the ongoing application of New Approach Methodologies (NAMs). These statements are subject to risks and uncertainties that may lead actual results to differ from projections, and SystImmune does not assume any obligation to update these statements.