Advancing a New Approach
Glioblastoma (GBM) is one of the most aggressive and deadly brain cancers.
Despite surgery, radiation, and chemotherapy, outcomes have not meaningfully improved in more than two decades. Most patients experience recurrence within months.
Alpheus is advancing a new therapeutic approach designed to improve outcomes while reducing treatment burden for patients and families.
How We’re Changing the Game
Alpheus is developing a non-invasive therapy that uses a tumor-accumulating drug together with low-intensity ultrasound to create localized activity inside the brain. The goal is to treat the tumor without exposing the rest of the body to high drug levels.
Treatment is delivered in an outpatient setting while patients are awake and is designed to be repeatable. Early clinical studies have demonstrated a favorable safety profile and encouraging biological and radiographic signals. A pivotal Phase 2b clinical trial in newly diagnosed GBM is currently enrolling patients.
The Science in Action
The Alpheus investigational therapy integrates a tumor-accumulating drug with a proprietary low-intensity ultrasound system to achieve localized pharmacologic activation inside the brain.
We are pursuing a 505(b)(2) regulatory path that builds on established drug safety data while introducing a novel, energy-based activation approach. Across early-stage studies, the therapy has shown consistent signals of localized drug activation, radiographic response, and biological activity, along with a favorable tolerability profile. These findings are preliminary and require confirmation in larger, controlled studies.
About Our Therapy
The patient takes a tumor-targeted drug that is already FDA-approved for use in brain tumor surgery.
The drug preferentially accumulates inside brain cancer cells, but not in healthy tissue.
Once the tumor cells are loaded with drug molecules, low-intensity diffuse ultrasound is delivered non-invasively to the brain.
When ultrasound activates the drug inside the cancer cells, it triggers the release of reactive oxygen species that damage the tumor cells.
The damaged tumor cells stimulate an immune response that helps the body clear the broken-down cancer cells.
