Overview
SonALAsense develops sonodynamic therapy (SDT), a noninvasive drug-device combination using SONALA-001, an intravenous aminolevulinic acid formulation, with MR-guided focused ultrasound to selectively target and kill cancer cells in tumors like high-grade gliomas and blood cancers. The company is advancing SDT in clinical trials, including for recurrent glioblastoma (NCT05370508) and diffuse intrinsic pontine glioma (DIPG), with FDA Fast Track and Orphan Drug designations. Recent $46 million ARPA-H funding supports SDT development for leukemia and multiple myeloma.
Frequently asked questions
- What is SonALAsense's core technology and how does it work?
- SonALAsense's sonodynamic therapy (SDT) combines SONALA-001, a proprietary intravenous drug that accumulates in cancer cells, with MR-guided focused ultrasound. Ultrasound generates light via sonoluminescence to activate a drug metabolite, triggering cell death selectively in tumors.
- What cancers is SonALAsense targeting in clinical trials?
- SonALAsense targets high-grade gliomas including recurrent glioblastoma (NCT05370508), diffuse intrinsic pontine glioma (DIPG) with FDA Fast Track designation, and blood cancers like leukemia and multiple myeloma under $46M ARPA-H funding.
- What regulatory designations has SONALA-001 received?
- SONALA-001 has FDA Orphan Drug Designation for malignant gliomas and Fast Track Designation combined with INSIGHTEC Exablate 4000 for DIPG. SDT is in Phase 1/2 clinical trials showing good tolerability.