- First clinical trial of photoimmunotherapy for gynecologic cancers
- Study funded by the Japan Agency for Medical Research and Development (AMED)
Hokkaido University Hospital has begun patient enrollment in Japan for an investigator-initiated clinical trial (IIT) of photoimmunotherapy in gynecologic cancers on October 1 (Japan time). Rakuten Medical, Inc. will provide investigational drug and medical devices for this IIT.
This Phase 2, single-arm, open-label IIT (jRCT2011240034) is designed to evaluate the safety and efficacy of ASP-1929 photoimmunotherapy for locally advanced or recurrent vulvar, vaginal, and cervical cancers. The study program has been selected for funding by the Japan Agency for Medical Research and Development (AMED).
The investigational drug and devices used in this IIT have previously been approved by Japan’s Ministry of Health, Labour and Welfare for unresectable locally advanced or recurrent head and neck cancer under the Conditional Early Approval System. This IIT marks the world's first clinical trial to investigate photoimmunotherapy using the drug and devices for gynecologic cancers.
Disclaimer: Rakuten Medical’s photoimmunotherapy based on the Alluminox™ platform are investigational outside Japan.
Vulvar, vaginal, and cervical cancers have an estimated annual incidence in Japan of 250, 150, and 10,000 cases, respectively.1 These cancers are predominantly squamous cell carcinomas, with 70-95% of cases showing epidermal growth factor receptor (EGFR) positivity.2-4 This profile is similar to that of head and neck cancers, which are also mainly squamous cell carcinomas and more than 90% EGFR-positive.5 Due to the accessible location of these cancers to the body surface, laser illumination in photoimmunotherapy is expected to be technically feasible.
Dr. Hidemichi Watari, Professor of Gynecology at Hokkaido University Hospital, and principal investigator of the IIT, commented:
“Existing treatment options for recurrent or advanced vulvar, vaginal, and cervical cancers often yield limited outcomes and may significantly impact patients’ quality of life. In cervical cancer, one of the most prevalent gynecologic cancers, high EGFR expression correlates with a poor prognosis, highlighting the need for new, targeted therapies. We are hopeful that the selective targeting mechanism of photoimmunotherapy may provide a new treatment option and offer a ray of hope for patients battling these challenging cancers.”
- The Japanese Society for Obstetrics and Gynecology, Gynecologic Ulcer Committee, Patient Annual Report, 2018-2020 https://www.jsog.or.jp/modules/committee/index.php?content_id=7#databook (2019-2021)
- Garganese, G. et al. The Vulvar Immunohistochemical Panel (VIP) Project: Molecular Profiles of Vulvar Squamous Cell Carcinoma. Cancers (Basel) 13 (2021). https://doi.org:10.3390/cancers13246373
- Brunner, A. et al. Expression of epidermal growth factor receptor and vascular endothelial growth factor in vaginal squamous cell cancer. Am J Obstet Gynecol 204, 171 e171-176 (2011). https://doi.org:10.1016/j.ajog.2010.09.031
- proteinatlas.org, H. P. A. EGFR, cervical cancer, Human pathology, Human Protein Atlas, https://www.proteinatlas.org/ENSG00000146648-EGFR/pathology/cervical+cancer#ihc
- Assuntina G Sacco et al. Current Treatment Options for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. 2015; 33(29):3305-13
About Rakuten Medical
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary Alluminox™ platform, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical’s photoimmunotherapy based on the Alluminox platform are 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.
About Alluminox™ platform
The Alluminox™ platform is Rakuten Medical’s investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing photoimmunotherapy using the Alluminox platform, 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® 700DX (IR700), that selectively binds 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 team from the National Cancer Institute in the United States. Outside Japan, Rakuten Medical’s photoimmunotherapy based on the Alluminox platform are investigational.
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.
