Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, is pleased to announce that, during the year 2023, findings from preclinical studies, clinical trials, and real-world data on Alluminox treatment (photoimmunotherapy) have been presented at multiple international conferences. The 21 presentations are listed at the end of the press release.
Mickey Mikitani, Co-CEO of Rakuten Medical, said, “Witnessing the surge in findings on Alluminox treatment shared at prestigious conferences around the world fills me with immense pride. We would like to thank all the dedicated healthcare professionals worldwide who share their excitement for this innovative technology and the potential of the Alluminox™ platform. Together with the medical community, we remain committed to advancing this treatment and shaping the future of patient care.”
ASP-1929 (Japanese product name: Akalux® IV Infusion 250 mg), the first drug developed on Rakuten Medical's proprietary Alluminox™ platform, was approved for unresectable, locally advanced or recurrent head and neck cancer in Japan under the Sakigake Designation System and the Conditional Early Approval System in September 2020. With the increase in the number of treatment cases in the clinic, a range of findings on the Alluminox treatment have been reported, including treatment results and management of adverse events.
* Rakuten Medical’s therapies based on Alluminox™ platform are investigational outside of Japan.
Significant progress was also made in clinical trial: Promising early evaluation data on safety and efficacy were observed in the Phase 1b/2 clinical trial (ASP-1929-181 study / ClinicalTrials.gov Identifier: NCT04305795) of ASP-1929 photoimmunotherapy in combination with anti-PD-1 therapy presented at the American Head and Neck Society International Meeting (AHNS) in July 2023 in Canada. To further explore these data, AI-based studies of biomarkers and drug uptake quantification in tumors have been conducted in collaboration with Rakuten Institute of Technology, and the findings were presented at the Society for Immunotherapy of Cancer (SITC) in the United States in November 2023. Rakuten Medical is currently considering initiating a new pivotal clinical trial to further demonstrate and confirm the safety and efficacy of this combination therapy.
In August 2023, Mikitani was invited as a keynote speaker at ASCO Breakthrough, which is organized in Asia by the American Society of Clinical Oncology (ASCO), the world's premier cancer society. In his keynote presentation, Mikitani recalled his first encounter with the innovative technology, photoimmunotherapy, and shared his hope and confidence in the potential of Rakuten Medical's Alluminox platform to contribute to the treatment of a variety of cancer types and stages in the future. The full recording of this keynote is available at the ASCO Breakthrough website, and a digest version (1:45) is available here:
<Presentations related to photoimmunotherapy at international conferences in 2023>
| FHNO 2023 (3 presentations) |
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| Meeting: The 23rd National Conference of Foundation for Head and Neck Oncology Location: Daman, India Dates: December 22-24, 2023 |
| Title: Photoimmunotherapy for Lower Gingival Cancer Presenter: Daisuke Nishikawa, Department of Head and Neck Surgery, Aichi Cancer Center, Japan |
| Title: Photoimmunotherapy for Recurrent Head and Neck Cancers - Japanese experience Presenter: Daisuke Nishikawa, Department of Head and Neck Surgery, Aichi Cancer Center, Japan |
| Title: Near-infrared Photoimmunotherapy: Translational research and clinical application Presenter: Ryuhei Okada, Head and Neck Surgery, Tokyo Medical and Dental University Hospital, Japan |
| For more information on the presentations at FHNO 2023, please see the press release. |
| TJCOHNS 2023 (3 presentations) |
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| Meeting: The 16th Taiwan-Japan Conference on Otolaryngology-Head and Neck Surgery Location: Taichung, Taiwan Dates: December 16-17, 2023 |
| Title: Photoimmunotherapy for Head and Neck Cancer (Abstract #: Ls2-1) Presenter: Kiyoaki Tsukahara, Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Japan |
| Title: Near-infrared Photoimmunotherapy: clinical application and translational research (Abstract #: Sy8-6) Presenter: Ryuhei Okada, Head and Neck Surgery, Tokyo Medical and Dental University Hospital, Japan |
| Title: Photoimmunotherapy for the treatment of head and neck cancer (Abstract #: P1-1) Presenter: Takeshi Shinozaki, Department of Head and Neck Surgery, Hospital East, National Cancer Center Japan |
| ASHNO 2023 (2 presentations) |
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| Meeting: The 8th Conference of the Asian Society of Head & Neck Oncology Location: Bangkok, Thailand Dates: November 27-29, 2023 |
| Title: Photoimmunotherapy for head and neck cancers: Roles and strategies Presenter: Shigeru Hirano, Otolaryngology-Head and Neck Surgery, Kyoto Prefectural University of Medicine, Japan |
| Title:Near-infrared Photoimmunotherapy against Head and Neck Cancers (Abstract #: O-25) Presenter: Ryuhei Okada, Head and Neck Surgery, Tokyo Medical and Dental University Hospital, Japan |
| SITC 2023 (2 posters) |
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| Meeting: The 38th Annual Meeting of the Society for Immunotherapy of Cancer Location: San Diego, US Dates: November 3-5, 2023 |
| Rakuten Medical Sponsored Title: Development of an image-based tumor microenvironment analysis coupled with peripheral flow cytometry reveals a distinct immune cell phenotype in responder patients in the Phase 1b/2 study ASP-1929-181 (Abstract #: 83) Presenter: Myra Gordon, Rakuten Medical, Inc., et al |
| Rakuten Medical Sponsored Title: Development of a novel, cellular-level drug uptake quantification pipeline for accurate quantification of fluorescence-conjugated therapeutics: Data from the Phase 1b/2 open-label study ASP-1929-181 (Abstract #: 1307) Presenter: Amy Thorne, Rakuten Medical, Inc., et al |
| For more information on the poster presentations at SITC 2023, please see the press release. |
| IAOO 2023 (2 presentations) |
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| Meeting: The 9th World Congress of the International Academy of Oral Oncology Location: Incheon, Korea Dates: November 1-4, 2023 |
| Title: Photoimmunotherapy for Recurrent Head and Neck Cancer (Abstract #: FP13-6) Presenter: Yuta Takatsu, Otolaryngology–Head & Neck Surgery, Fujita Health University Hospital, Japan |
| Title: Non-Surgical Treatment for Oral Cancer (Abstract #: SS15-5) Presenter: Kenichi Nibu, Department of Otolaryngology-Head and Neck Surgery, Kobe University Graduate School of Medicine, Japan |
| ASCO Breakthrough 2023 (1 presentation) |
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| Meeting: 2023 ASCO Breakthrough Location: Yokohama, Japan Dates: August 3-5, 2023 |
| Title: Innovative Technology in Oncology Presenter: Mickey Mikitani, Rakuten Medical, Inc. |
| AHNS 2023 (5 presentations) |
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| Meeting: The 11th International Conference on Head and Neck Cancer of the American Head and Neck Society Location: Montreal, Canada Dates: July 8-12, 2023 |
| Rakuten Medical Sponsored Title: Safety and efficacy findings from a phase 1b/2 open-label study of a novel combination of ASP-1929 photoimmunotherapy with anti-PD-1 therapy in EGFR-expressing advanced head and neck squamous cell carcinoma (Abstract #: S252) Presenter: Ann M. Gillenwater, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center, US |
| For more information on the presentation in the above title at AHNS 2023, please see the press release. |
| Title: Photo-immunotherapy with Puncture-Guide Plate and Planning Navigation System (Abstract #: S155) Presenter: Takayoshi Suzuki, Department of Otolaryngology-Head and Neck Surgery Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Japan |
| Title: RM-1929 Photoimmunotherapy Impact of Catheter Placement on Outcomes (Abstract #: S242) Presenter: Ayan Kumar, Department of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, US |
| Title: Long-term Survival with Photoimmunotherapy in Patients with Recurrent Head and Neck Cancer (Abstract #: S397) Presenter: Victor Jegede, Department of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, US |
| Title: An experience of Alluminox treatment for head and neck cancer in clinical practice in Japan (Abstract #: S403) Presenter: Nobuhiro Hanai, Department of Head and Neck Surgery, Aichi Cancer Center, Japan |
| SNMMI 2023 (1 presentation) |
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| Meeting: The Society of Nuclear Medicine and Molecular Imaging 2023 Annual Meeting Location: Chicago, US Dates: June 24-26, 2023 |
| Title: Early FDG Response after Near-Infrared Photoimmunotherapy for Head and Neck and Cutaneous Squamous Cell Carcinoma (Abstract #: P50) Presenter: Liza Lindenberg, Molecular Imaging Branch, National Cancer Institute |
| For more information on the presentation at SNMMI 2023, please see the press release. |
| IFHNOS 2023 (2 presentations) |
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| Meeting: The 7th World Congress of the International Federation of Head and Neck Oncologic Societies Location: Rome, Italy Dates: June 21-25, 2023 |
| Title: Alluminox platform: the novel photoimmunotherapy for the head and neck cancer Presenter: Ichiro Tateya, Department of Otolaryngology & Head and Neck Surgery, Fujita Health University, Japan |
| Title: Local depletion of immune suppressor cells using near-infrared photoimmunotherapy Presenter: Ryuhei Okada, Head and Neck Surgery, Tokyo Medical and Dental University Hospital, Japan |
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, 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. 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 research and products, including the Alluminox™ platform, combination therapies and related medical devices, as well as our commercial activities, 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 and situations and 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.
