Cetuximab

- Engaged with FDA Commissioner on shared commitment to fast, safe, and affordable patient access to innovative therapies SAN DIEGO, June 13, 2025 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, today announced that it was selected by the U.S. Food and Drug Administration (FDA) to participate in the FDA CEO Forum in San Diego, California, on June 13, 2025. Minami Maeda, President of Rakuten Medical, attended the meeting in person as a member of this panel, to discuss with FDA Commissioner Marty A. Makary, M.D., M.P.H., and other industry leaders how the FDA can "modernize its regulatory framework to better support innovation and patient access to safe and effective therapies". Rakuten Medical – whose innovative cancer therapeutic technology, the Alluminox™ platform, is in Phase 3 trials in the U. S. – was selected to join the forum as one of the companies at the front lines of medical discovery. Rakuten Medical's novel treatment modality, known as photoimmunotherapy, is designed to induce rapid and selective depletion of cancer or immunosuppressive cells with minimal impact on surrounding healthy tissue. Moreover, pre-clinical observation have shown that photoimmunotherapy may also stimulate both innate and adaptive anti-tumor immune responses. "Rakuten Medical's Alluminox™ platform has the potential to transform cancer therapy in the U.S.," said Maeda. "We are honored to be recognized by the FDA and invited to contribute to discussions on how regulatory innovation can accelerate the delivery of pioneering treatments to patients. We fully support the FDA's vision of a modern framework that ensures timely access, safety, and affordability." Rakuten Medical is currently conducting a global Phase 3 clinical trial evaluating its ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 / Acronym: ECLIPSE / ClinicalTrials.gov Identifier: NCT06699212). A prior Phase 1b/2 study showed promising interim evaluation results, including a 24-month survival rate of 52.4% and a median overall survival (OS) not yet reached. ASP-1929 photoimmunotherapy received the world's first regulatory approval in Japan under the Conditional Early Approval System based on a certain level of efficacy and acceptable safety from Phase 1/2a trial results. It is being delivered to patients in Japan at an affordable price. Disclaimer: Rakuten Medical's Alluminox™ platform-based photoimmunotherapy is investigational outside Japan. About Rakuten Medical, Inc. Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox™ platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical's photoimmunotherapy is 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 . 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 Alluminox platform-based photoimmunotherapy, 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 to 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 his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical's Alluminox platform-based photoimmunotherapy is investigational. About ASP-1929 Rakuten Medical's first pipeline drug developed on its Alluminox™ platform is ASP-1929, an antibody-dye conjugate comprised of the anti-EGFR 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 illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. 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. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority. Contact Us SOURCE Rakuten Medical, Inc. 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NEW YORK, June 10, 2025 /PRNewswire/ -- Increased activity in a specific biological pathway may explain why many patients with a deadly form of skin cancer do not respond to the latest cancer treatments, a new study shows. Publishing in the journal Cancer Research online June 10, the study featured data generated from experiments with human tissues and cells from patients with advanced melanoma that were implanted into mice. Results uncovered therapeutic targets that could limit melanoma growth in patients whose cancer failed to respond to initial treatment with immune checkpoint inhibitors. Led by researchers at NYU Langone Health and its Perlmutter Cancer Center, the study focused on a subgroup of melanoma patients with mutations in the neurofibromin 1 (NF1) gene. NF1 mutations — random changes in the molecular "letters" that make up this gene's DNA code — are just one type among several mutations, including those in the BRAF, NRAS, and PARP genes, that are linked to many cases of cancer, particularly melanoma. As many as 27% of melanoma patients are estimated to have NF1 mutations. While immunotherapy, which stimulates the immune system to attack cancer cells as it would an invading virus, has proved to be a successful treatment, it does not work well for more than half of NF1-mutant melanoma patients. "There is a pressing need for new drug therapies for melanoma patients with neurofibromin 1 mutations that do not respond to the latest immunotherapy, and for which there are no subsequent effective treatment options," said study lead investigator Milad Ibrahim, PhD. Ibrahim is a postdoctoral fellow in the Dr. Iman Osman Laboratory in the Ronald O. Perelman Department of Dermatology at the NYU Grossman School of Medicine. To investigate why these patients were treatment resistant, investigators examined tumor cells from 30 melanoma patients who did not respond to immunotherapy. NF1 mutations were found in 40% of these melanoma samples. The samples came from NYU Langone's extensive repository from more than 6,000 melanoma patients. Molecular testing showed that the signaling pathway built around a protein called epidermal growth factor receptor (EGFR) was more active in NF1 mutant melanoma cells than in cells with other melanoma-gene mutations. Increased EGFR activity has long been linked to abnormal cell growth in tumors and shorter survival with various cancers. The researchers also found that NF1 mutant melanoma cells depended on increased EGFR activity for survival, regardless of the presence of other mutations. Because EGFR-inhibiting drugs are already used to treat some head and neck cancers, as well as colorectal and lung cancers, researchers then tested two drugs in the class, cetuximab and afatinib, in both NF1 mutant cell cultures and cancer cell lines without NF1 mutations. After transplanting both tumor cell types into mice and treating them with these drugs, results showed that both EGFR inhibitors were effective against cells and transplanted tumors with NF1 mutations, and they had no effect on melanomas without NF1 mutations. "Our study results reveal a unique vulnerability in melanoma patients with neurofibromin 1 mutations, that an overexpression of the epidermal growth factor receptor pathway is essential for their survival and growth," said study senior investigator Iman Osman, MD. Osman is the Rudolf L. Baer Professor in the Ronald O. Perelman Department of Dermatology at the NYU Grossman School of Medicine and a member of the Perlmutter Cancer Center. Osman is also director of the interdisciplinary melanoma program and associate dean of clinical research strategy at NYU Langone. "While further tests are needed, our results support a novel approach of deploying EGFR inhibitors either alone or in combination with other immunotherapies for treatment of melanoma patients whose tumors harbor NF1 mutation," said study co-senior investigator Markus Schober, PhD. Schober is an associate professor in the Ronald O. Perelman Department of Dermatology at the NYU Grossman School of Medicine and a member of the Perlmutter Cancer Center. However, Schober says this requires further testing in a clinical trial, which the research team plans to develop. He adds that if trial findings prove successful, the team's research could provide a lifeline for many of these melanoma patients. Metastatic melanoma, as the disease is formally called, kills nearly 10,000 Americans annually. Funding for the study was provided by National Institutes of Health grants P50CA225450, U54CA263001, and P30CA016087. Additional funding support was provided by Melanoma Research Foundation grant 1287389. Besides Ibrahim, Osman and Schober, NYU Langone researchers involved in this study are co-investigators Irineu Illa-Bochaca, George Jour, Eleazar Vega-Saenz de Miera, Joseph Fracasso, Kelly Ruggles, and Jeffrey Weber. About NYU Langone Health NYU Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. Vizient Inc. has ranked NYU Langone No. 1 out of 115 comprehensive academic medical centers across the nation for three years in a row, and U.S. News & World Report recently placed nine of its clinical specialties among the top five in the nation. NYU Langone offers a comprehensive range of medical services with one high standard of care across seven inpatient locations, its Perlmutter Cancer Center, and more than 320 outpatient locations in the New York area and Florida. With $14.2 billion in revenue this year, the system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise. Media Contact Shira Polan (from June 6 to June 10) 212-404-4279 [email protected] David March (after June 10) 212-404-3528 [email protected] STUDY DOI 10.1158/0008-5472.CAN-24-3904 STUDY LINK SOURCE NYU Langone Health System WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED