A leading head and neck surgeon, Dr. Cognetti, highlighted the results and his experiences from a Phase 1/2a trial evaluating RM-19291 in the US
Disclaimer: Rakuten Medical’s therapies based on Alluminox™ platform are investigational outside of Japan.
Rakuten Medical held a virtual R&D Day on March 16, 2023 for an audience limited to pre-registered attendees from around the world. During the event, Rakuten Medical showcased what the Company wants to achieve through its photoimmunotherapy based investigational technology Alluminox™ platform and what data the first pipeline asset ASP-1929 has shown in clinical trials and in the real world.
Takashi Toraishi, Co-CEO and President of Rakuten Medical began the event by introducing the Company’s mission, the overview of its technology, and the vision it hopes to achieve, as follows.
“Rakuten Medical is engaged in global pharmaceutical and medical device R&D activities based on the Alluiminox™ platform. Pre-clinical data have shown to provide rapid and selective cell death.”
Abhijit Bhatia, Chief Operating Officer of Rakuten Medical provided the track record in Japan where the first pipeline asset ASP-1929 has been marketed since January 2021, the overall pipeline including two other clinical-stage investigational assets RM-1995 and RM-0256, device development, and important upcoming milestones.
“ASP-1929 is currently subject to a global Phase 3 study (ASP-1929-301/ClinicalTrials.gov Identifier: NCT03769506), and a Phase 2 study of ASP-1929 in combination with PD-1 (ASP-1929-181/ClinicalTrials.gov Identifier: NCT04305795) is also underway in US. This year, we hope to share data from ongoing studies at an international conference.”
The highlight of the event was a presentation by David M. Cognetti, MD, a Professor and Chair in the Department of Otolaryngology – Head and Neck Surgery at Thomas Jefferson University Hospital. He detailed the published data on the preliminary safety and efficacy reported in a Phase 1/2a study of RM-19291 photoimmunotherapy in patients with locoregional, recurrent head and neck cancer (ASP-1929-101 / ClinicalTrials.gov Identifier: NCT02422979), and also shared two cases of his patients who participated in the clinical trial and received long-term follow-up.
“RM-1929 photoimmunotherapy has demonstrated response rates with a tolerable and manageable safety profile in heavily pre-treated patients. After the study closed, we continued to follow patients and observed responses which are encouraging and warrant further investigation.”
Toshiaki Suzuki, Chief Medical Officer of Japan Alluminox™ Treatment at Rakuten Medical described two of the eight publications based on commercial cases in Japan – one paper2 evaluating Quality of Life (QoL) and another case report3 on oropharyngeal cancer.
“In the two years since the launch of our products, eight papers have been published, some of which show promising results.”
If you would like to view a replay of R&D Day, please click here to register and access the recording: https://lifescipartners.zoom.us/webinar/register/WN_W-fXtm49Q7me8Uh7OrFDow
- RM-1929 and ASP-1929 are analogous. Internal Rakuten Medical physiochemical studies show that they have comparable physical and chemical properties.
- Isaku Okamoto et al. Cancers (Basel). 2022 Sep; 14(18): 4413. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9496661/
- Daisuke Nishikawa et al. Cancers (Basel). 2022 Nov; 14(22): 5662. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9688155/
About Rakuten Medical, Inc.
Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell targeting investigational therapies on its Alluminox™ platform, which, in pre-clinical studies, have been shown to induce rapid and selective cell killing and tumor necrosis. Outside of Japan, Alluminox therapies have not yet been approved as safe or effective by any regulatory authority. The company’s first drug developed on the Alluminox platform, ASP-1929, has received conditional 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 by delivering our innovative treatments as quickly and safely as possible to as many patients all over the world as possible. The company has offices in 6 countries, including the United States, where it is headquartered, Japan, the Netherlands, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.
About Alluminox™ platform
The Alluminox™ 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 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 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 Alluminox 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 as safe or effective by any regulatory authority.
Forward Looking Statements
This article contains “forward looking” statements as defined under the (United States) 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.