On June 28, 2022 SonALAsense, a pioneer in the development of SONALA-001 and sonodynamic therapy (SDT), a new drug-device combination developed to manage deadly cancers so patients can become survivors, reported clinical, organizational and growth updates (Press release, SonALAsense, JUN 28, 2022, View Source [SID1234616341]). It is the only company with SDT in clinical trials .
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"At SonALAsense, we have been on a journey to develop a non-invasive treatment option for patients with rare brain cancers who often have little hope," said Mark de Souza, PhD, Founder and Chief Executive Officer. "Today we are excited to announce the culmination of our hard work as we confidently advance SDT into clinical trials as the only non-invasive drug-device combination therapy for the treatment of recurrent glioblastoma multiforme (rGBM) and diffuse intrinsic pontine glioma (DIPG)."
Clinical Update
SonALAsense is working on two trials to evaluate the therapeutic potential of SONALA-001 SDT for DIPG and rGBM. The DIPG trial is actively recruiting and the rGBM clinical trial will begin recruiting shortly.
The primary objective of the Phase 1/2 DIPG study is to evaluate the safety and tolerability of ALA SDT and determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of MR-Guided Focused Ultrasound (MRgFUS) energy in combination with SONALA-001 in patients with DIPG. This rare, and deadly, childhood brain tumor is aggressive and affects the pons or brainstem, which controls many of the body’s functions.
The Phase 2 trial in rGBM builds on positive proof of concept results from the first-in-human Phase 0/1 clinical trial of SONALA-001 SDT in recurrent high grade gliomas (rHGG) being conducted by Dr. Nader Sanai at the Ivy Brain Tumor Center. The initial results indicated that SDT rapidly led to targeted oxidative stress and cell death in human HGG tissue without off-target effects and was well tolerated in patients. The Phase 0/1 trial is continuing to enroll rHGG patients.
Growth Update
SonALAsense was founded and is led by scientific, medical and administrative professionals with decades of experience in developing and commercializing drug-device systems in photodynamic therapy and new drug therapies for rare diseases. They have assembled a diverse and exceptional team of thought leaders who are committed to improving treatment options for patients.
"We continue to expand the depth and breadth of our leadership and scientific expertise," said Stuart Marcus, MD, PhD, Founder, Chief Medical Officer, and Chief Scientific Officer at SonALAsense. "Many of my colleagues have worked alongside me for two decades, applying our accumulated knowledge as a close-knit team to efficiently bring this breakthrough technology from bench to bedside and positively impact the lives of those battling these deadly brain tumors."
Three new established individuals have joined the SonALAsense team of industry veterans. April Freeman has joined as Director of Patient Engagement and Advocacy, along with respected doctors Margaret Dugan and Graeme Woodworth who have recently joined the Scientific Advisory Board.
Ms. Freeman has more than 15 years of experience in the biotech industry, working as a patient advocate at bluebird bio and at BridgeBio where she worked closely with Dr. de Souza.
Dr. Dugan has led several drug development programs in oncology through FDA approval, including temozolomide, the standard of care in GBM. She is the former Senior VP & Global Program Head at Novartis Oncology and held clinical development positions at Schering-Plough and American Cyanamid.
Dr. Woodworth is Professor of Neurosurgery at the University of Maryland School of Medicine and Director of its Brain Tumor Treatment & Research Center. He is a leading neurosurgeon and researcher in the therapeutic potential of focused ultrasound to treat brain tumors.
Funding Update
The Company’s growth strategy continues to advance after raising $25 million funding from successful Series A and B financing rounds and a ~$2 million NCI SBIR grant to help fund the DIPG clinical trial. Proceeds from the financing have allowed the Company to build a team of R&D experts focused on advancing SDT through clinical trials for patients with rGBM and DIPG.