First Patient Treated in Rakuten Medical?s Global Phase 3 Trial in India
23.01.2024 - 02:41:04First Patient Treated in Rakuten Medical?s Global Phase 3 Trial in India. A potential new innovative treatment option for head and neck cancers with high unmet needs
Business Wire IndiaRakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, today announced that the first patient in India received Alluminox treatment (photoimmunotherapy) using ASP-1929 in August 2023 under Rakuten Medical’s global, pivotal Phase 3 clinical trial (ASP-1929-301 study/ClinicalTrials.gov Identifier: NCT03769506, CTRI Number: CTRI/2023/05/052728) for patients with locoregional, recurrent head and neck squamous cell carcinomas (HNSCC). The ASP-1929-301 study is currently ongoing in countries and regions including the United States, India and Taiwan, and will enroll a total of 275 patients globally. In India, six leading medical institutions are currently participating in the ASP-1929-301 study.
Alluminox treatment is gaining increasing interest in India as the trial progresses, and two physicians were invited from Japan to present their extensive experiences using this treatment at the 23rd National Conference of Foundation for Head and Neck Oncology, held in Daman, India, on December 22-24, 2023.
In India, more than 200,000 new cases of head and neck cancer are diagnosed each year, which accounts for approximately 25% of all new head and neck cancer cases worldwide1. In addition to the high occurrence of head and neck cancer, the majority of these patients present with advanced disease, which also corresponds with poorer outcomes2. Such high volumes of advanced stage patients can present many challenges for surgeons and medical oncologists who treat head and neck cancer, as treatment options for such patients are limited. Surgery, radiation, and chemotherapy are all commonly used to manage this patient population – but more options are needed.
Dr. Subramania Iyer K., an investigator for the ASP-1929-301 study at the Amrita Institute of Medical Sciences and Research Centre (Kochi), stated in an interview conducted by Rakuten Medical in July 2023, “When we had discussion about it (Alluminox treatment), we thought it was one of the most innovative ideas which we should try to implement and look at it. I hope and I'm sure that this will make a lot of difference in the way we treat cancers in the future.”
https://youtu.be/lT4NriAoDpc
About ASP-1929-301 study
?
The multi-center, randomized, open-label, global Phase 3 study of Alluminox treatment using ASP-1929 will evaluate the efficacy and safety of ASP-1929 in patients with locoregional, recurrent HNSCC who have previously failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy, and are not eligible for surgery or radiation. Participants will be randomized to receive experimental therapy or investigator’s choice of systemic therapy (2:1). The dual primary endpoints of the study are progression-free survival and overall survival, and the key secondary endpoint is objective response rate.
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.
About ASP-1929
Rakuten Medical’s first pipeline drug developed on its Alluminox™ platform is ASP-1929, an antibody-dye conjugate comprised of the antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptor (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 non-thermal red light (690 nm) illumination emitted by a laser device system, resulting in photochemical reaction. This is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. ASP-1929 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) in January 2018, and is currently under investigation in a global Phase 3 clinical trial for recurrent head and neck cancer. 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. Outside of Japan, ASP-1929 has not yet been approved by any regulatory authority.
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.
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Alluminox treatment is gaining increasing interest in India as the trial progresses, and two physicians were invited from Japan to present their extensive experiences using this treatment at the 23rd National Conference of Foundation for Head and Neck Oncology, held in Daman, India, on December 22-24, 2023.
In India, more than 200,000 new cases of head and neck cancer are diagnosed each year, which accounts for approximately 25% of all new head and neck cancer cases worldwide1. In addition to the high occurrence of head and neck cancer, the majority of these patients present with advanced disease, which also corresponds with poorer outcomes2. Such high volumes of advanced stage patients can present many challenges for surgeons and medical oncologists who treat head and neck cancer, as treatment options for such patients are limited. Surgery, radiation, and chemotherapy are all commonly used to manage this patient population – but more options are needed.
Dr. Subramania Iyer K., an investigator for the ASP-1929-301 study at the Amrita Institute of Medical Sciences and Research Centre (Kochi), stated in an interview conducted by Rakuten Medical in July 2023, “When we had discussion about it (Alluminox treatment), we thought it was one of the most innovative ideas which we should try to implement and look at it. I hope and I'm sure that this will make a lot of difference in the way we treat cancers in the future.”
https://youtu.be/lT4NriAoDpc
About ASP-1929-301 study
?
The multi-center, randomized, open-label, global Phase 3 study of Alluminox treatment using ASP-1929 will evaluate the efficacy and safety of ASP-1929 in patients with locoregional, recurrent HNSCC who have previously failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy, and are not eligible for surgery or radiation. Participants will be randomized to receive experimental therapy or investigator’s choice of systemic therapy (2:1). The dual primary endpoints of the study are progression-free survival and overall survival, and the key secondary endpoint is objective response rate.
- Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.fr/today, accessed Dec 13, 2023
- Kulkarni MR. Head and Neck Cancer Burden in India. Int J Head and Neck Surg 2013;4(1):29-35 https://www.ijhns.com/doi/pdf/10.5005/jp-journals-10001-1132
?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 developing our innovative treatments as quickly as possible for patients 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.
About ASP-1929
Rakuten Medical’s first pipeline drug developed on its Alluminox™ platform is ASP-1929, an antibody-dye conjugate comprised of the antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptor (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 non-thermal red light (690 nm) illumination emitted by a laser device system, resulting in photochemical reaction. This is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. ASP-1929 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) in January 2018, and is currently under investigation in a global Phase 3 clinical trial for recurrent head and neck cancer. 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. Outside of Japan, ASP-1929 has not yet been approved by any regulatory authority.
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.
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