SAN DIEGO, CA, USA I December 15, 2021 I Rakuten Medical, Inc today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to begin clinical studies of RM-1995 photoimmunotherapy in patients with advanced cutaneous squamous cell carcinoma or with head and neck squamous cell carcinoma.

RM-1995 photoimmunotherapy treatment is an investigational drug-device combination being developed by Rakuten Medical, Inc. The drug portion of the treatment, RM-1995, is a conjugate of a photoactivatable dye (IRDye® 700DX [IR700]) and a monoclonal antibody specific for cell-surface interleukin 2 (IL-2) receptor α-chain (CD25). The device portion of the treatment is a laser device system (PIT690 Laser System) used to activate IR700 by illumination with 690nm nonthermal red light. Tumor-resident regulatory T cells (Tregs), that inhibit antitumor immune responses to promote tumor growth, can be specifically targeted with anti-CD25 antibodies1. Rakuten Medical, Inc is investigating RM-1995 as a potential new treatment to provide targeted, direct reduction of Tregs specifically within light-treated tumor lesions to induce systemic anticancer immune responses.

“We are very excited to have achieved this regulatory milestone and delighted to be moving RM-1995 into the clinic,” said Mickey Mikitani, Chief Executive Officer of Rakuten Medical, Inc. “RM-1995 has the potential to attack the cancer in a novel way, targeting Tregs. Based on data from preclinical studies, RM-1995 photoimmunotherapy treatment is expected to result in acute killing of Tregs within the tumor. We are developing drugs using various antibodies in our drug discovery program based on Rakuten Medical’s IlluminoxTM platform, and RM-1995 is the second pipeline drug developed on this platform. We will continue to advance our business with a sense of speed so that we can deliver these important treatments to as many patients as possible.”

About Rakuten Medical, Inc.

Rakuten Medical, Inc. is a global clinical stage biotechnology company developing and commercializing precision, cell-targeting investigational therapies on its IlluminoxTM platform, which, in pre-clinical studies have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. The company’s first drug developed on the Illuminox platform, ASP-1929, has received approval from the Japanese Ministry of Health, Labour, and Welfare, and is currently the subject of a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. The company has 6 locations in 5 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, and Switzerland. For more information, visit

About RM-1995

RM-1995, developed by Rakuten Medical using its IlluminoxTM platform, is an antibody-dye conjugate comprised of a monoclonal antibody specific for cell-surface interleukin 2 (IL-2) receptor α-chain (CD25) and IRDye® 700DX (IR700), a light-activatable dye. RM-1995 photoimmunotherapy is designed to specifically kill CD25+ regulatory T cells (Tregs) within solid tumors, once illuminated with 690nm nonthermal red light.2 Rakuten Medical’s preclinical data has suggested that RM-1995 photoimmunotherapy treatment can be utilized to specifically deplete intratumoral Tregs, thereby alleviating local Treg-mediated restraint within the tumor microenvironment, rapidly improving the CD8 T cell: Treg ratio, and reinvigorating effector CD8+ T cell responses.

1Arce Vargas F, Furness AJS, Solomon I, Joshi K, Mekkaoui L, Lesko MH, et al. Fc-Optimized Anti-CD25 Depletes Tumor-Infiltrating Regulatory T Cells and Synergizes with PD-1 Blockade to Eradicate Established Tumors. Immunity. 2017;46(4):577-586.

2 Sato, K. et al. Spatially selective depletion of tumor-associated regulatory T cells with near-infrared photoimmunotherapy. Sci Transl Med 8, 352ra110, doi:10.1126/scitranslmed.aaf6843 (2016).

About Illuminox™ platform 

The Illuminox platform is an investigational 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 Illuminox 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 non-thermal 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 Illuminox may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted cells and/or the removal of immunosuppressive elements within the microenvironment. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective by any regulatory authority.

SOURCE: Rakuten Medical