Carlos Garcia, Chief Technology OfficerThe company focuses on developing precision, cell-targeting investigational therapies on its Illuminox™ technology platform. Illuminox is based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and the team from the National Cancer Institute in the United States. This technology platform is just an antibody, a small molecule that represents a new form of therapy with the potential to selectively target cancer cells while sparing surrounding normal tissues through light-activatable antibody-dye conjugates.
Illuminox entails drug and laser device components. While the former consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding, the latter consists of a light source that locally illuminates the targeted cells with non-thermal light to transiently activate the drug. Used as an alternative method to fight cancer, this combination of technology identifies an antibody that binds directly to an antigen coupled with a dye. The patient initially gets treated with the drug and, the next day is treated with the device where the light is used and dosed at a particular wavelength to the tumor.
We at Rakuten Medical are focused on bringing an investigational treatment approach for our patients to provide them with one if the best options to fight cancer
One of the first drugs developed on Illuminox is ASP-1929, an antibody-drug conjugate comprised of the antibody cetuximab and a light activatable dye. ASP-1929 binds to epidermal growth factor receptors (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck cancer, esophageal cancer, lung cancer, colon cancer, and pancreatic cancer. ASP-1929 has achieved Fast Track designation from the FDA and approval from the Ministry of Health, PMDA Japan, which is considered one of the most conservative regulatory bodies globally. Currently, the drug is under investigation in a global phase 3 clinical trial for recurrent head and neck cancer.
Although Illuminox therapies are under the radar of various regulatory authorities, the company is developing a viable commercial process to work with its vendors, commercial manufacturing organizations, and collaborators. The delay in regulatory approval mainly stems from the time-consuming nature of drug evaluation and regulatory approval. As an assertion to this, Garcia adds, “When you are trying to develop a novel, innovative program, which is first in class, it is challenging. And, fortunately, we have got approval in Japan with our lead program.” In addition to this, Rakuten Medical is also moving forward with product development by conducting clinical trials of monotherapy and combination therapy with other drugs.
Garcia credits the Illuminox platform’s value proposition to the team of Rakuten Medical, led by Mikitani. Having its subject matter expertise, the company plans its expansion to other countries such as China, India, and the other Asia Pacific regions. With such technology offering in place, Rakuten Medical has gained major traction in the US. Soon, the company will enter phase three trial in the US. Moving forward, the company will build its strategy for identifying and expanding new Illuminox programs. “We are committed to developing a treatment for as many patients as possible, as soon as safely possible, with an ultimate goal of conquering cancer one day,” concludes Garcia.
Rakuten Medical Announces New Management Team to Drive the Next Phase of Growth and Innovation
Monday, August 26, 2024
•Mickey Mikitani, as sole CEO, reaffirms his commitment to the company's mission of conquering cancer for patients all over the world
•Minami Maeda has been appointed as the new President to expedite pipeline development, with a strategic focus on securing FDA approval for ASP-1929, expanding into broader Asia, and further driving commercial growth in Japan
•A new global Phase 3 clinical trial for ASP-1929 photoimmunotherapy in combination with anti-PD-1 is expected to be initiated in 2H 2024
SAN DIEGO-- Rakuten Medical, Inc. announces that Hiroshi "Mickey" Mikitani now serves as its sole Chief Executive Officer and Vice Chairman of the Board, and Minami Maeda has been appointed as its new President, effective August 9, 2024. Takashi "Tora" Toraishi has chosen to step down from his role as Co-Chief Executive Officer, President and Board Director.
The new management team is set to further advance Rakuten Medical's Alluminox™ platform and prioritize obtaining FDA approval for ASP-1929 as early as possible. The company's new global Phase 3 study of ASP-1929 photoimmunotherapy in combination with anti-PD-1 for first-line recurrent head and neck squamous cell carcinoma (HNSCC) is expected to commence first in the United States in 2H 2024.
Rakuten Medical also aims to extend its reach into Asian markets, where many countries face high unmet medical needs, by leveraging its growing expertise from commercial treatments in Japan. Asia accounts for half of the world's cancer incidence and has the highest cancer mortality rate*. Rakuten Medical's strong track record of commercial success in Japan has generated substantial scientific publications, which the company believes would help support new medical communities' better understanding of the Alluminox™ platform. In Japan, the company will continue to drive growth and vigorously support the realization of its strategic agenda in the U.S. and Asia.
Mickey Mikitani, Chief Executive Officer and Vice Chairman of the Board of Rakuten Medical, stated, "The appointment of Minami as President and the formation of our new management team underscores our unwavering commitment to advancing our innovation for patients in need. We continue striving to advance cancer treatment through our technology platform, and I am fully committed to further driving the company's vision and strategic direction."
"I am honored to take on this pivotal role at such a critical time for Rakuten Medical," said Minami Maeda, President of Rakuten Medical. "Our treatment has positively impacted patients' lives in Japan, as demonstrated by our robust commercial growth there. I am excited to collaborate with our talented team to build an even stronger company and extend our contributions to more patients and broader communities as we continue to pursue our global development efforts."
Since joining Rakuten Medical in November 2017, Maeda has demonstrated outstanding leadership and strategic acumen. Most recently serving as Chief Commercial Officer of Rakuten Medical, Inc., and Representative Director & President of Rakuten Medical K.K., he has significantly contributed to commercial growth and established a scalable business model for the company's innovative drug-device combination in Japan. His efforts have greatly enhanced the company's global growth and technological advancements. Prior to his tenure at Rakuten Medical, Maeda gained extensive experience in business and public policy through his work at McKinsey & Company's Tokyo and Johannesburg offices. He also served as Chief of Staff to Japan's Minister of Health, Labor, and Welfare.
Rakuten Medical extends its gratitude to Toraishi for his strong leadership and contributions since 2017. His tenure has been marked by significant achievements, including the successful development and the world-first approval of ASP-1929 in Japan, and the establishment of a strong foundation for future growth.
