FDA Clears SystImmune IND for Bispecific Antibody SI-B037, First to Use Organ-on-Chip Toxicology Package
核心洞察
The FDA has cleared SystImmune (搜索)'s IND for SI-B037 (搜索), an investigational bispecific antibody for advanced solid tumors (搜索) that progressed on or are refractory to standard therapies.
The clearance enables a Phase 1/1b first-in-human study to determine optimal dosing and characterize initial clinical activity of the antibody.
It 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.
SystImmune (搜索) has received US FDA clearance of its investigational new drug application for SI-B037 (搜索), an investigational bispecific antibody for advanced solid tumors (搜索), allowing the Redmond, Washington-based company to begin a Phase 1/1b first-in-human study. The trial will enroll patients whose disease has progressed on or become refractory to standard therapies, and will evaluate dosing and characterize initial clinical activity.
The company has not disclosed the molecular targets of SI-B037 (搜索), describing the antibody only as targeting immunosuppression and other synergistic mechanisms. SystImmune (搜索) is the US subsidiary of Chengdu-based Sichuan Biokin Pharmaceutical (搜索) and serves as the group's US development arm.
A Nonclinical Package Built on New Approach Methodologies
The IND is SystImmune (搜索)'s first to rely on New Approach Methodologies (NAMs) as part of an integrated nonclinical safety and translational assessment package, replacing conventional animal toxicology studies with human organ-on-chip systems and primary human tissue models.
"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 (搜索). "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."
The company said the models were intended to provide a more human-relevant assessment of a molecule designed to engage multiple pathways, and that it plans to continue working with regulators on translational endpoints and safety models.
Regulatory and Clinical Rationale
SystImmune (搜索) framed the clearance as part of a broader shift toward human-centric, non-animal testing alternatives encouraged by regulatory authorities worldwide.
"Patients with advanced solid tumors (搜索) 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 (搜索), while continuing to collaborate closely with regulatory agencies to refine translational endpoints and human-relevant safety models in future studies."
Pipeline Context
SystImmune (搜索) develops bi-specific and multi-specific antibodies and antibody-drug conjugates, with several assets in various stages of clinical trials for solid tumor and hematologic indications. Its more advanced programs include izalontamab brengitecan, an EGFR (搜索)×HER3 (搜索) bispecific ADC partnered with Bristol Myers Squibb (搜索) outside China. The company also has a preclinical pipeline of cancer therapeutics in discovery or IND-enabling stages.