- 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, Aug. 19, 2024 /PRNewswire/ -- Rakuten
Medical, Inc., a global biotechnology company developing and
commercializing oncology precision, cell-targeting
photoimmunotherapy through its proprietary Alluminox™ platform,
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.
Disclaimer: Rakuten Medical's therapies based on Alluminox™
platform are investigational outside of Japan.
* Bray F, Laversanne M, Sung H, Ferlay J,
Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022:
GLOBOCAN estimates of incidence and mortality worldwide for 36
cancers in 185 countries. CA Cancer J Clin. 2024
May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024
Apr 4. PMID: 38572751.
About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a
global biotechnology company developing and commercializing
precision, cell targeting therapies based on its proprietary
Alluminox™ platform, which, in pre-clinical studies, has been shown
to induce rapid and selective cell killing and tumor necrosis.
Alluminox therapies have not yet been approved outside of
Japan. Rakuten Medical is
committed to its mission to conquer cancer by delivering its
innovative treatments as quickly as possible to as many patients as
possible all over the world. The company has offices in 5
countries/regions, including the United
States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit
www.rakuten-med.com.
About Alluminox™ platform
The Alluminox™ platform is
an investigational technology platform based on a cancer therapy
called photoimmunotherapy, which was developed by Dr. Hisataka
Kobayashi and team from the National Cancer Institute
in the United States. Rakuten
Medical is developing the Alluminox platform as a technology
consisting of a drug, device, and other related components. The
drug component of the platform consists of a targeting moiety
conjugated with one or more dyes leading to selective cell surface
binding. The device component consists of a light source that
locally illuminates the targeted cells with light to transiently
activate the drug. Pre-clinical data have shown that this
activation elicits rapid and selective necrosis of targeted cells
through a biophysical process that compromises the membrane
integrity of the targeted cells. Therapies developed on the
Alluminox platform may also result in local and systemic innate and
adaptive immune activation due to immunogenic cell death of the
targeted cancer cells and/or the removal of targeted
immunosuppressive cells within the tumor microenvironment. Outside
of Japan, Alluminox therapies have not yet been approved by
any regulatory authority.
Forward Looking Statements
This press release contains
forward looking statements that correspond to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
These statements include various risks, uncertainties, and
assumptions that may cause Rakuten Medical's business plans and
results to differ from the anticipated results and expectations
expressed in these statements. These "forward looking statements"
contain information about the status and development of our
products, including the Alluminox™ platform, as well as other
regulatory and marketing authorization efforts, the potential
benefits, efficacy, and safety of therapies created using the
Alluminox platform, and the status of regulatory filings. The
approval and commercial success of the product may not be achieved.
Forward looking statements relate to the potential benefits,
efficacy, and safety of our therapies, and the status of regulatory
filings. Such statements may include words such as "expect,"
"believe," "hope," "estimate," "looks as though," "anticipate,"
"intend," "may," "suggest," "plan," "strategy," "will," and "do",
and are based on our current beliefs. In addition, this press
release uses terms such as "important," "notable," and "abnormal"
to express opinions about clinical trial data. Ongoing clinical
trial studies include various risks and uncertainties, in
particular, problems that arise during the manufacturing stage of
our therapies, the occurrence of adverse safety events, situations
in failure to demonstrate therapeutic benefits, and other various
risks and uncertainties, both reasonable and unreasonable. For this
reason, actual results, including regulatory approvals and
uncertainties in the commercialization process of our therapies,
may differ from published information. Except to the extent
required by applicable law, we undertake no obligation to publicly
update this or any other forward-looking statement, whether because
of new information, future developments or events, changes in
assumptions, changes in the factors affecting forward-looking
statements. If one or more forward-looking statement(s) is updated,
no inference should be drawn that additional updates will be made
to those or other forward-looking statements.
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SOURCE Rakuten Medical, Inc.