Berkeley, CA, December 14, 2020—SonALAsense, a pioneer with the goal of managing fatal cancers so patients can become survivors, today announced the first of its kind non-invasive sonodynamic therapy (SDT) platform technology for treating recurrent glioblastoma multiforme (rGBM) and other lethal brain cancers.

rGBM is a deadly cancer with limited treatment options. SonALAsense’s SDT aims to make rGBM manageable, rather than lethal, with a unique combination therapy where aminolevulinic acid (ALA) is taken up selectively by tumor cells. The drug is then activated by non-invasive MRI-guided ultrasound, effectively targeting only tumor cells for destruction.

Giving hope to patients through strategic collaborations

The company has entered into a Collaboration and License Agreement with Insightec to develop and commercialize its focused ultrasound technology in oncology for use in ALA SDT. The company also entered into an Agreement with the Ivy Brain Tumor Center at Barrow Neurological Institute to conduct a first-in-human clinical trial in rGBM using their innovative Phase 0 approach to rapidly assess safety, and biological and clinical efficacy of ALA SDT.

The ALA SDT process works by a dual action which quickly kills brain tumor cells and simultaneously triggers programmed tumor cell death within 48 hours in animal models. ALA is currently FDA approved as a visual aid for neurosurgeons as the selective fluorescence of its metabolite in GBM cells helps guide surgical excision. Because of ALA’s unique selectivity for gliomas as well as the precision-targeted energies of MRI-guided focused ultrasound used for SDT, we believe the treatment should be safe for normal brain tissue.

“The discovery that light-activated drugs can also be activated by focused ultrasound has led to our development of sonodynamic therapy, which is the achievement of my life’s goal, to bring renewed hope to brain tumor patients without the use of invasive procedures.” said Stuart Marcus, MD, PhD, Founder, CEO and CMO of SonALAsense. “There have been many studies and research around treating rGBM and other lethal brain tumors over the years, but none have been proven effective. ALA SDT has the potential to meaningfully improve the length and quality of patients’ lives.”

“The Ivy Brain Tumor Center strives to be at the forefront of best-in-class solutions so that we can identify early-stage therapies for accelerated development,” said Nader Sanai, MD, Director and Chief Scientific Officer of the Ivy Brain Tumor Center. “We are proud to collaborate with SonALAsense to work towards the first non-invasive drug-device combination therapy for glioblastoma and other aggressive brain tumors. This novel modality has the potential to change the lives of hundreds of thousands of patients and their families, worldwide.”

Leading with expertise

SonALAsense is led by experts with decades of deep experience in developing and commercializing drug-device systems in Photodynamic Therapy and new drug therapies for orphan disease.

Founder, CEO and CMO Stuart Marcus, MD, PhD, has pioneered photodynamic therapy systems for 33 years, with multiple FDA approved drug-device products. He has spent the past 27 years working towards this breakthrough technology that has the potential to turn rGBM patients into cancer survivors.

COO and CFO Mark de Souza, PhD, is an entrepreneur in the rare disease space and has been a biotech executive for over 15 years.

Director of Clinical Research Anna Houlihan has over 20 years of clinical operations experience, with prior experience at DUSA Pharmaceuticals and Lederle.

The company is supported by a scientific advisory board that boasts prominent physicians in the neuro-oncology, oncology, neurosurgery, ophthalmology, and radiology space, including:

Scott Plotkin, MD, PhD, Chief, Division of Neuro-Oncology, MGH, Armenise Harvard Professor of Neurology, Harvard Medical School.

Mitchel S. Berger, MD, Professor and Chairman, Neurosurgery, UCSF.

Pejman Ghanouni, MD, PhD, Associate Professor, Radiology, Stanford University Medical Center.

Robert Scott, MBBS, FRCS(Edin), FRCOphth, DM, Honorary Professor, University of Birmingham, UK

About SonALAsense

SonALAsense is a clinical-stage company developing ALA sonodynamic therapy (SDT) as a first-in-class, non-invasive drug-device combination for the treatment of recurrent glioblastoma multiforme and other deadly cancers. SDT utilizes MRI-guided focused ultrasound (the device) in combination with aminolevulinic acid (a drug) to selectively target and kill tumor cells. SonALAsense is working closely with the Ivy Brain Tumor Center to advance ALA SDT into a Phase 0/2 clinical trial in recurrent GBM.

For more information about SonALAsense, visit www.sonalasense.com.