Glioblastoma (GBM), the most common primary brain tumor, has median patient survival of little more than one year. Surgical resection of all enhancing tumor prolongs survival, yet successful resection is challenging because GBM tumors diffusely infiltrate the brain, which results in >90% local recurrence. Development of a next-generation fluorescent molecular imaging agent to help surgeons differentiate cancerous from normal tissue intraoperatively will help reduce the rate of local recurrence and improve patient survival outcomes. No such agent for guided surgical resection of GBM currently has US FDA approval.
In this Academic-Industrial Partnership, a team with expertise in molecular biology, neurosurgery and molecular imaging regulatory approval, will work together to translate SBK2 from a preclinical to a clinical agent. To achieve this goal, the team will need to perform cGMP synthesis and toxicology studies before obtaining FDA regulatory approval for investigational use. Upon FDA approval, the cGMP SBK2 agents will be tested in a Phase 0 eIND imaging trial during surgical resection of GBM for determination of safety profile and imaging efficacy. We expect that this translational plan for the SBK2 imaging agent will yield a new clinical imaging capability for surgeon end users to reduce tumor burden and prolong patient survival.