Rakuten Medical, a biotech offshoot of Japanese tech conglomerate Rakuten, is pushing to bring its photoimmunotherapy cancer treatment to the U.S., according to CEO Minami Maeda in an interview with Fortune.
'We're essentially asking surgeons to put down their knives, and pick up this lightsaber,' Maeda said, describing the technology that uses light to treat cancer.
The San Diego-headquartered firm is directing about 95% of its resources toward cracking the U.S. market. The treatment is already used for head and neck cancers in Japan, and the company is now running Phase 3 clinical trials in the U.S., with a target FDA submission in 2028.
'The U.S. is the world's biggest market, and it's also where a lot of capital is deployed,' Maeda said. 'We want to be able to treat all solid tumors, rather than stop at just head and neck cancers, that means we need significant capital to be invested into R&D.'
The technology has roots in an accidental 2011 discovery by Japanese scientist Hisataka Kobayashi and his team at the U.S. National Cancer Institute. Kobayashi had been using photoimmunotherapy to visualize cancer cells, not to treat them.
'But when they were doing an experiment, they realized that cancers were disappearing, and eventually attempted to use it for therapeutic reasons,' Maeda explained.
Rakuten Medical produces the proprietary drug Akalux and the Alluminox technology platform used to administer photoimmunotherapy. The drug binds to the epidermal growth factor receptor on cancer cells and tags them with a light-activated dye; red light is then applied to selectively kill the tagged cells. Maeda said the approach is minimally invasive and helps preserve patients' quality of life.
'In 10 years' time, I hope everybody believes that this technology could be the fifth pillar of cancer treatment, aside from surgery, radiation, chemotherapy and immunotherapy,' he said.
Adoption in Japan was slow at first. The firm treated just 30 patients in its first year there; it now treats about 700 to 800 a year across some 200 hospitals. To overcome doctors' hesitation, the company installs the Alluminox platform in hospitals free of charge and charges a minimal fee per use. Profits come mostly from sales of the Akalux drug, a strategy akin to selling printers cheaply and making money on ink.
'If your company sells both printers and ink, you can't sell both at very high prices, since the printer is an enabler,' Maeda said.
Maeda said Rakuten Medical's Japan branch is profitable, though the global entity operates at a loss due to high research spending.
In the short term, the company is looking to enter markets that acknowledge Japanese regulatory approval of Akalux, including Taiwan, Macau, Singapore, Hong Kong and Saudi Arabia. Maeda sees Macau as a gateway to mainland China, saying that treating a few dozen patients there 'opens up a gateway for the Greater Bay Area' and that building Chinese population data would help with potential partners and commercialization. He also wants to bring the technology to emerging markets in Southeast Asia, saying, 'Technology like ours, which is inexpensive and easy to deploy, could actually really help these populations.'