Redmond, Washington-based SystImmune, the US subsidiary of Chengdu-based Sichuan Biokin Pharmaceutical, received US FDA clearance of an investigational new drug application for SI-B037, an investigational bispecific antibody for advanced solid tumors. The clearance allows SystImmune to move the program into a Phase I/Ib first-in-human study in patients whose disease has progressed on or become refractory to standard therapies.
SystImmune has not disclosed the molecular targets of SI-B037, describing the antibody only as targeting immunosuppression and other synergistic mechanisms. The planned Phase I/Ib study will evaluate dosing and characterize initial clinical activity in advanced solid tumors.
The IND is distinguished by the nonclinical package supporting it. SystImmune said this was its first IND application to use New Approach Methodologies (NAMs), including human organ-on-chip systems and primary human tissue models, in place of conventional animal toxicology studies. 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.