Rakuten Medical

Rakuten Medical

Develops Alluminox photoimmunotherapy cancer treatment platform

Overview

Rakuten Medical develops and commercializes the Alluminox platform for cancer treatment. Alluminox is based on photoimmunotherapy and combines a drug, a device, and related components to destroy cancer cells when activated by light. The company generates revenue by selling its cancer treatment products to healthcare providers and patients. Unlike many firms that offer a single therapy, Rakuten Medical builds a platform that integrates drug and device elements to deliver photoimmunotherapy across different cancer types. Its goal is to bring these treatments to market in a way that creates a sustainable healthcare ecosystem, providing access to better cancer care for people worldwide and working toward conquering cancer.

About Rakuten Medical

Simplify's Rating
Why Rakuten Medical is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Biotechnology

Healthcare

Company Size

51-200

Company Stage

N/A

Total Funding

$906.9M

Headquarters

San Mateo, California

Founded

2010

People at Rakuten Medical

People at Rakuten Medical who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • Global Phase 3 ECLIPSE trial targets FDA BLA submission in 2028 for first-line recurrent head and neck cancer treatment.
  • RM-0256 anti-PD-L1 conjugate received AMED funding in 2025, enabling Phase 1 development for malignant epithelial tumors with triple MOA.
  • LOTTE Holdings' April 2026 investment and GMP manufacturing deal in Syracuse secure supply chain for global Phase 3 and future commercialization.

What critics are saying

  • ASP-1929-381 Phase 3 trial may fail to show OS improvement over pembrolizumab, blocking 2028 BLA and eliminating primary asset.
  • FDA may reject ASP-1929 BLA due to insufficient synergistic efficacy evidence, terminating U.S. market entry and collapsing valuation.
  • LOTTE BIOLOGICS Syracuse manufacturing delays could disrupt Phase 3 supply, causing enrollment delays and loss of regulatory momentum in 6–12 months.

What makes Rakuten Medical unique

  • Rakuten Medical uniquely develops Alluminox platform-based photoimmunotherapy combining drug and laser device for selective cancer cell necrosis.
  • ASP-1929 is Japan-approved for head and neck cancer since 2020, with over 1,300 treatments establishing a commercial foundation.
  • Dual mechanism of action includes direct tumor necrosis and immune activation via immunogenic cell death, unlike conventional antibody therapies.

Help us improve and share your feedback! Did you find this helpful?

Funding

Total Funding

$906.9M

Above

Industry Average

Funded Over

13 Rounds

Notable Investors:
Series F funding comparison data is currently unavailable. We're working to provide this information soon!
Series F Funding Comparison
Coming Soon

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Stock Options

401(k) Retirement Plan

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Rakuten Medical
Apr 30th, 2026
Rakuten Medical announces two poster presentations and Exhibit booth at ASCO 2026 Annual Meeting.

Rakuten Medical announces two poster presentations and Exhibit booth at ASCO 2026 Annual Meeting. April 30, 2026 * First presentation of results from a global Phase 3 study of ASP-1929 photoimmunotherapy as monotherapy in locoregional recurrent head and neck squamous cell carcinomas (HNSCC) * Real-world Japanese multicenter data on photoimmunotherapy in recurrent nasopharyngeal carcinoma Disclaimer: Rakuten Medical's Alluminox(R) platform-based photoimmunotherapy is investigational outside Japan. SAN DIEGO - April 30, 2026 - Rakuten Medical, Inc., a global biotechnology company developing and commercializing the Alluminox platform-based photoimmunotherapy, today announced that two abstracts have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from May 29 - June 2, 2026. One poster will feature the first presentation of safety and efficacy data from Rakuten Medical's global Phase 3, randomized, double-arm, open-label, controlled study (ASP-1929-301; NCT03769506) evaluating ASP-1929 photoimmunotherapy for locoregional, recurrent HNSCC. This ASP-1929-301 study was conducted at 40 facilities across the U.S., Taiwan, Japan, India, and Ukraine. Another poster, authored by a research team of Japanese physicians, will present the latest findings from an investigator-initiated multicenter observational study evaluating the efficacy and safety of photoimmunotherapy for recurrent nasopharyngeal cancer in clinical practice in Japan. Rakuten Medical will also have a booth in the Exhibit Hall. The Company medical team will be pleased to welcome ASCO participants at booth #37147. Poster Presentation for ASP-1929-301 Study: * Abstract Title: A phase 3, randomized, double-arm, open-label, controlled study of ASP-1929 photoimmunotherapy (PIT) versus physician's choice standard of care (SOC) for patients with locoregional, recurrent head and neck squamous cell carcinoma (HNSCC) * Abstract Number: 6080 * Abstract Link: https://www.asco.org/abstracts-presentations/261461 * Session Name: Poster Session - Head and Neck Cancer * Session Date: Saturday, May 30, 2026 * Session Time: 1:30 p.m. - 4:30 p.m., CDT * First Author: Anastasios Maniakas, Assistant Professor of Head and Neck Surgery at The University of Texas MD Anderson Cancer Center * Location: Exhibit Hall A, Poster Board #537 Poster Presentation for Real-World Japanese Multicenter Data: * Abstract Title: Real-world efficacy and safety of photoimmunotherapy for recurrent nasopharyngeal carcinoma: A nationwide multicenter study in Japan * Abstract Number: 6030 * Abstract Link: https://www.asco.org/abstracts-presentations/263351 * Session Name: Poster Session - Head and Neck Cancer * Session Date: Saturday, May 30, 2026 * Session Time: 1:30 p.m. - 4:30 p.m., CDT * First Author: Hideki Tanaka, Department of Otolaryngology, Head and Neck Surgery, Tokyo Medical University * Location: Exhibit Hall A, Poster Board #384 Rakuten Medical Booth: * Location: Exhibit Hall A, Booth #37147 * Exhibit Dates: Saturday - Monday, May 30 - June 1, 2026 About Alluminox(R) platform The Alluminox(R) platform is Rakuten Medical's investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye(R) 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical's 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 tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational. About ASP-1929 Rakuten Medical's first pipeline drug developed on its Alluminox(R) platform is ASP-1929, an antibody-dye conjugate comprised of the anti-epidermal growth factor receptor (EGFR) antibody cetuximab and IRDye(R) 700DX, a light activatable dye. ASP-1929 binds to EGFR, a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority. About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox(R) platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering 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. Media & Investor Contact: Ai Yoshikawa Associate Director, Global Corporate Communications & Investor Relations Tel: +81-(0)70-4196-0845 Email: [email protected]

PressReleaseJapan.net
Apr 2nd, 2026
LOTTE HOLDINGS Healthcare and Biopharmaceutical CVC announces investment in Rakuten Medical, Inc.

LOTTE HOLDINGS Healthcare and Biopharmaceutical CVC announces investment in Rakuten Medical, Inc. April 2, 2026 Tokyo, Japan - [April 2, 2026] - LOTTE HOLDINGS, CO., LTD. (Tokyo, Japan; CEO: Genichi Tamatsuka, hereinafter "LOTTE HOLDINGS") announces a strategic investment into Rakuten Medical, Inc. (hereinafter "Rakuten Medical"), a global biotechnology company developing and commercializing photoimmunotherapy-based anticancer therapies through its proprietary Alluminox(R) platform. Founded in 2010 and headquartered in San Diego, CA, Rakuten Medical is currently advancing ASP-1929, its first photoimmunotherapy drug, through a global Phase 3 clinical trial evaluating the therapy in combination with pembrolizumab as a first-line treatment for recurrent head and neck cancer. With the goal of generating pivotal data to support a planned Biologics License Application (BLA) submission to the U.S. FDA in 2028, Rakuten Medical is enrolling patients across the United States, Japan, Taiwan, and Ukraine, with clinical sites in Poland expected to be activated soon. Beyond head and neck cancer, Rakuten Medical is also broadening its development pipeline through internal programs and investigator-initiated trials. Planned efforts include a Phase 1 clinical study of RM-0256 photoimmunotherapy for solid tumors in Japan, expected to begin in the second quarter of 2026 with grant support from the Japanese government, as well as ongoing investigator-initiated trials in esophageal and gynecologic cancers. Alongside this, the company continues to grow the commercial presence in Japan, where the ASP-1929 photoimmunotherapy products have received regulatory approvals for head and neck cancer, reinforcing its operational base and helping to support global expansion activities. This investment was made by LOTTE HOLDINGS Healthcare & Biopharmaceutical Corporate Venture Capital (HB-CVC), an investment arm of LOTTE HOLDINGS, and will further strengthen Rakuten Medical's operational capabilities across these key clinical and commercial initiatives. In parallel with LOTTE HOLDINGS' investment, LOTTE BIOLOGICS and Rakuten Medical executed a Master Service Agreement during the 2026 J.P. Morgan Healthcare Conference. This agreement provides for GMP-compliant manufacturing of Rakuten Medical's products at LOTTE BIOLOGICS' Syracuse facility in New York and supports Rakuten Medical's global clinical and future commercial supply strategy. The collaboration further aligns the LOTTE Group's biopharmaceutical capabilities with Rakuten Medical's global efforts to accelerate patient access to its novel oncology therapeutics. Joon Paek, Managing Partner of LOTTE HOLDINGS Healthcare & Biopharmaceutical CVC commented: "Our investment reflects LOTTE HOLDINGS' strong confidence in the potential of Rakuten Medical's Alluminox(R) platform and the company's clear momentum toward U.S. regulatory milestones and global expansion. With LOTTE BIOLOGICS now engaged under a master service agreement to provide GMP manufacturing support, we see tangible operational synergies that can help accelerate development and scale. Backed by the broader capabilities of the LOTTE Group, we are proud to support Rakuten Medical's innovations that represent a meaningful step forward in precision oncology and align with our commitment to advancing transformative healthcare technologies." About LOTTE HOLDINGS CO., LTD. Company Name: LOTTE HOLDINGS CO., LTD. Headquarters: 3-20-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 160-0023, Japan Representative Director: Genichi Tamatsuka LOTTE HOLDINGS engages in a diverse range of businesses, including its core confectionery and ice cream sectors, professional baseball team management, real estate, finance, CVC, hotels, and healthcare. Looking ahead, the company aims to drive further innovation in the food industry and boldly pursue the creation of new businesses by integrating opportunities from both Japan and South Korea. Established in Tokyo, Japan, in 1948 with the manufacturing and sale of chewing gum, the LOTTE Group now operates with headquarters in both Japan and South Korea. The group conducts business across approximately 35 countries and regions worldwide, spanning sectors such as food, distribution, retail, biopharmaceuticals, healthcare, data centers, hotels and resorts, entertainment, and construction. Embracing the unified group vision of "Lifetime Value Creator," LOTTE Group is committed to continually providing value throughout every stage of people's lives. About LOTTE BIOLOGICS Headquartered in Seoul, South Korea, LOTTE BIOLOGICS was founded in 2022 with a mission to deliver therapies that contribute to a healthier world. At the Syracuse Bio Campus in New York, LOTTE BIOLOGICS provides high-quality GMP manufacturing services for drug substances. The facility offers a total production capacity of 40,000L, supported by eight 5,000L stainless steel bioreactors. Additionally, the campus includes extensive analytical QC testing laboratories and warehouse facilities that have received approval from over 62 regulatory agencies worldwide. LOTTE BIOLOGICS is also advancing into a new area of expertise with Antibody-Drug Conjugates (ADCs) conjugation services and offering a seamless, end-to-end service from drug substance manufacturing to conjugation. Looking ahead, LOTTE BIOLOGICS is constructing an advanced biomanufacturing facility at its Songdo Bio Campus in South Korea. With construction of the first plant already underway and expected to be operational by 2027, the facility will be equipped with eight 15,000-liter stainless steel bioreactors for commercial production, as well as multiple 2,000-liter single-use bioreactors for clinical manufacturing. Together, these will form a manufacturing hub with a total bioreactor capacity exceeding 120,000 liters. More information about LOTTE BIOLOGICS, please visit: www.lottebiologics.com About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing its Alluminox(R) platform-based photoimmunotherapy, which has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in five countries/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com. About the Alluminox(R) Platform The Alluminox(R) platform is Rakuten Medical's investigational technology that combines pharmaceuticals, medical devices, medical technology and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration, and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye(R) 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690 nm) to transiently activate the drug. Rakuten Medical's preclinical 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 tumor cells and/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational. About ASP-1929 Rakuten Medical's first pipeline drug developed on its Alluminox(R) platform is ASP-1929, an antibody-dye conjugate comprised of the anti-epidermal growth factor receptor (EGFR) antibody cetuximab and IRDye(R) 700DX, a light activatable dye. ASP-1929 binds to EGFR, a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority.

Recently Posted Jobs

Sign up to get curated job recommendations

Rakuten Medical is Hiring for 3 Jobs on Simplify!

Find jobs on Simplify and start your career today

Don't see your dream role? Check out thousands of other roles on Simplify. Browse all jobs →