- In 2020, SONIRE Therapeutics was founded in Tokyo, Japan.
- The company has launched a clinical trial assessing their novel focused ultrasound device for the treatment of pancreatic cancer.
- We spoke with the SONIRE’s CEO, Tohru Satoh, about this trial and what makes their device unique.
SONIRE Therapeutics Inc. is headquartered in Tokyo, Japan, and has just announced a new clinical trial assessing their novel focused ultrasound device for the treatment of unresectable pancreatic cancer. We spoke with the company’s CEO, Tohru Satoh, about this trial and what makes their device unique.
How was the company started?
In 2020, SONIRE was founded and began developing a next-generation ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system using the technology, clinical know-how, and regulatory science experience built over a decade at Tokyo Women’s Medical University, Tohoku University, and Tokyo Medical University.
Tell us about your company structure: ownership, lead executives, and their roles.
SONIRE was established by three members, myself (Tohru Satoh as President, chief executive officer, and founder); Jun Okamoto, PhD, as Vice President, chief operating officer, and founder; and Shin Yoshizawa, PhD, as chief technology officer and technical founder. The company operates with investment from several venture capital firms.
- Tohru Satoh
I was previously involved in the overseas development of Opdivo at Ono Pharmaceutical and established and managed overseas subsidiaries as a representative. I also served as Director of Business Planning at Oncolys Biopharma, and I was a board member of Liquid Biotech USA, which was launched from the University of Pennsylvania.
- Jun Okamoto, PhD
Jun Okamoto, PhD, has been involved in the development of surgical assistance robots and smart operating theaters at the Institute for Advanced Biomedical Research and Innovation at Tokyo Women’s Medical University. He is a part-time lecturer at Tokyo Women’s University and Waseda University. He earned his PhD in mechanical engineering and was awarded the Minister of Health, Labour and Welfare Prize at the 1st Japan Innovation Awards hosted by the Cabinet Office.
- Shin Yoshizawa, PhD
Shin Yoshizawa, PhD, is a professor of Communications Engineering at Tohoku University’s Graduate School of Engineering. His expertise is in medical ultrasound and fluid engineering, development of technologies related to therapeutic ultrasound, acoustic cavitation, and ultrasound imaging of bubbles.
In general, what is the current status of your company?
SONIRE is conducting a multicenter, randomized clinical trial for unresectable pancreatic cancer in Japan. The study enrolls 90 patients divided into two groups, HIFU + chemotherapy group and chemotherapy group. Chemotherapy is used as standard therapy, Nal-IRI/FL, mFOLFIRINOX, or Gem/nab-PTX, at the physician’s choice. Since the primary endpoint of this study is overall survival, we will confirm the effect of prolonged survival by the addition of HIFU treatment.
How many years has your treatment platform or products been in development, and what are its origins? Does your focused ultrasound equipment or treatment platform have a name?
The development code of SONIRE’s focused ultrasound system, used in the clinical trial described above, is Suizenji. The system was developed based on a device used in a clinical study for pancreatic cancer in Japan in 2017.
What are some of the technical challenges your group has had to overcome?
SONIRE’s system uses cavitation bubbles to enhance treatment efficacy and visualize the treatment area in ultrasound imaging. We have been developing technologies to ensure the reproducibility of cavitation-enhanced therapy and to ensure safety in the presence of cavitation for many years, including research at universities.
What challenges do you have to tackle moving forward?
We are focused on demonstrating clinical benefit and building clinical evidence through clinical trials now. After clinical evidence has been shown, we will challenge to obtain appropriate reimbursement and position HIFU treatment in a clinical practice guideline.
What are the benefits of your technology over other companies?
The use of cavitation increases the heating efficiency, enabling thermal therapy with lower acoustic energy. In addition, the implementation of a method to reduce HIFU interference components in ultrasound images has made it possible to provide clear ultrasound images even during HIFU exposure. These are key features to achieve both safety and treatment throughput in our system.
Have you learned any lessons for watching the experience of the other companies?
We have referred to the data from oncology clinical trials not only for ultrasound therapy, but also for radiotherapy and drugs.
Do you partner with other companies or research teams?
Our company has formed a strategic business alliance with Hirata corporation, which manufactures SONIRE’s HIFU therapy system. We have continued academic partnerships with Tohoku University, Tokyo Women’s Medical University, and Tokyo Medical University since before our company was established. We are also newly collaborating with Tokyo University of Pharmacy and Life Science to accumulate data from basic experiments.
Is your system or equipment approved for commercial use in any markets? If so, how is it being used in these markets?
Our HIFU system is still under development, and we hope to file for approval with the result of the ongoing clinical trial.
Which health conditions or diseases will your technology be used for?
Our first target disease is pancreatic cancer. Following that, we would like to expand the indications to include other intractable cancers.
If applicable, tell us about your related clinical studies and the results.
The initial feasibility trial was conducted at Tokyo Medical University using SONIRE’s prototype, but the data are still under preparation for publication.