Born and raised in Japan, Takashi “Tora” Toraishi has a master's degree and a Ph.D. from the University of Tokyo, in nuclear chemistry. Before he joined Rakuten Medical, Tora worked in the molecular biology and chemistry field. He acted as a partner for McKinsey & Company, providing management consultancy in the advanced industry sector. Now, Tora, as the Co-CEO of Rakuten Medical, is leading a globally integrated team in an effort to develop more options for cancer patients based on its photoimmunotherapy-based technology platform called Alluminox™.
GeneOnline had the opportunity to interview Tora and learn more about his point of view on the unmet clinical needs in oncology. Moreover, he elaborated on how Rakuten Medical’s Alluminox platform, an investigational technology based on a cancer therapy called photoimmunotherapy, could provide cancer patients with a new treatment option. Tora also touched on the current status of the global pipeline based on the Alluminox platform and Rakuten Medical’s ultimate mission.
From Being Impressed to Leading
In 2016, the founder of Rakuten Group, Inc., Hiroshi “Mickey” Mikitani asked Tora to investigate photoimmunotherapy as a potential treatment to cure his father’s cancer, and Tora was amazed by the technology.
“As I read through the clinical data and scientific papers about photoimmunotherapy, I was impressed with a startup’s technology,” said Tora, “Treating diseases by linking specific antibodies with photosensitizers and using the antibody to target the specific cell at the same time is more than performing surgery to the (cancer) cells. It is a unique modality.”
Seeing the potential of the technology, Tora officially began his journey of co-leading Rakuten Medical (Aspyrian Therapeutics at the time) in April 2017.
“My mission is not to make big money from the company,” he said , “but to bring this unique technology to the market as early as possible to contribute to the cancer community.”
But leading a small start-up company can be challenging. Tora pointed out that there were only ten members when he joined the company. However, with the mission to benefit more cancer patients as soon as possible, he worked hard to establish a global team across the U.S., Japan, Taiwan, and Europe, and to ensure the technology’s development is completely aligned with the company's strategy.
All the hard work started to pay off when Rakuten Medical finally received its first approval in Japan for its leading drug component ASP-1929 (brand name in Japan: Akalux®) and device (BioBlade®) based on its Alluminox platform to treat head and neck cancer in 2020.
The Oncology Market Requires More Modalities
When it comes to the most urgent unmet clinical needs in oncology, Tora pointed out that, for the upcoming ten, to even thirty years, the oncology solutions (e.g., treatments, mental care, biomarkers, etc.) will be more tailor-made to reach precision medicine. In order to do that, Tora thinks having multiple modalities on hand, such as immuno-oncology drugs, cell therapies, chemotherapies, surgery, as well as photoimmunotherapy, is a must for oncologists. In addition, fully understanding the breadth of the technology is also crucial.
“When we develop a drug based on the Alluminox platform, we should know about the advancement of the surgery, because image-guided surgeries and robotics, for example, would change the positioning of our technology.”
Alluminox Platform, the Technology Innovation in Oncology
The Alluminox platform is Rakuten Medical’s investigational precision technology based on photoimmunotherapy, consisting of drug and device components. The drug component, consisting of a tumor-targeting moiety conjugated to a light activatable dye, selectively binds the surface of target cells. Illuminating the targeted cells with non-thermal red light activates the cell-bound drug, which, in pre-clinical studies, has been observed to lead to rapid and selective cell killing with minimal effects on surrounding tissues. ASP-1929, targeting EGFR, is Rakuten Medical’s lead drug component and has been marketed in Japan as Akalux®since January 2021. ASP-1929 is currently the subject of a global Phase 3 clinical trial evaluating the efficacy and safety of the compound for recurrent head and neck cancer. Rakuten Medical is also studying applications of this technology beyond head and neck cancer.
Tora believes that the oncology market desperately needs another innovative technology combination. Ongoing clinical trials involving Rakuten Medical’s Alluminox platform may confirm its potential as one of the solutions to meet unmet clinical needs.
“People often ask us what our competitive advantage is,” said Tora with confidence, “There are many technologies that can be in competition in the market in the short term, but I’m not seeing them as competitors. If I were a patient or family member of the patient, I would like to have more technologies and more tools for me to choose from. So I’m willing to develop one of the technology options available to patients.”
After Approval, the Japanese Oncology Market Has Recognized Alluminox platform
ASP-1929 (brand name Akalux in Japan) received conditional marketing approval in Japan under the indication of unresectable locally advanced or recurrent head and neck cancer from the Ministry of Health, Labour and Welfare (MHLW, 厚労省) in September 2020. In January 2021, Rakuten Medical commercialized the product. Since then, treatment using Akalux has become available at more than 100 hospitals throughout Japan. (ASP-1929 has not been approved by any regulatory body, including the FDA, outside of Japan.)
“Whenever Japanese physicians believe that the local regional control would provide benefits to patients with head and neck cancer, they can use our technology after the patients have received surgery, chemotherapy, and radiation therapy.”
Expanding Alluminox Trials Globally and Targeting New Indications
To expand the commercial success of ASP-1929 in Japan globally, Rakuten Medical is running a global Phase 3 clinical trial of ASP-1929 in recurrent head and neck squamous cell carcinoma. In the U.S., Rakuten Medical is also running a Phase 2 study with the National Cancer Institute, investigating the efficacy and safety of a single ASP-1929 photoimmunotherapy administered prior to standard of care surgical tumor resection in patients with operable primary or recurrent head and neck squamous cell carcinoma or cutaneous squamous cell carcinoma.
Rakuten Medical’s Ultimate Mission
“Ultimately, our mission is conquering cancer,” said Tora, with a smile on his face, “but I’m not saying that we conquer cancer as a company; instead, we will be a part of the journey, together with any other.”
Having around 200 employees globally, Tora hopes Rakuten Medical can run the pharmaceutical development process by itself from start to finish on a global scale, from running clinical studies, bringing other molecules to the table, and operating in different countries, with the aim to really make a difference to the industry.
Tora ended the interview with great confidence in company’s technology, “We believe that once our technology is proven to work, it will grow, and others will support it.”
Not only does Tora see great potential in Rakuten Medical’s technology, he also feels honored to lead the energized, motivated, and mission-oriented team as the Co-CEO to bring new options for cancer patients. What’s more, Tora hopes to oversee the company’s goal of providing available and accessible technologies for patients. These features will help it evolve in the oncology market and are things that Tora thinks Rakuten Medical, a small start-up, can leverage to compete with big pharmaceutical companies.
“I’m willing to create a different success model in the market, and everyone will follow us. Then we may provide some impacts on society,” said Tora, “our company is unique, which I’m proud of.”
The interview was conducted by Thomas Huang, CEO of GeneOnline, and the article was written by Aurora Mau.
