Cetuximab Sarotalocan Sodium (Genetical Recombination)

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。去年2024年3月6日,来自日本的Rakuten Medical（乐天医药）完成1.19亿美元E轮融资(约合8.7亿人民币，以近期汇率换算)。（和韩国乐天无关）该公司目前已经商业化的品种为Akalux (cetuximab sarotalocan)（IRDye 700DX (IR700) near-infrared photosensitizing dye），通过光化学-局部近红外照射方法，来提高治疗的特异性，降低药物的系统毒性；可称为一款光免疫疗法ADC（西妥昔单抗 -偶联 -光敏活性成分IR700-水溶性硅酞菁衍生物）。通过独特的Alluminox™平台开发而成的Photoimmunotherapy分子。Akalux (cetuximab sarotalocan)（研发代码：ASP-1929，RM-1929），本品于2020年9月25日全球范围内首次获批，获得日本厚生劳动省（Pharmaceuticals and Medical Devices Agency ， PMDA）批准上市，用于治疗治疗不可切除的局部晚期或复发性头颈癌（附条件批准上市，参与的临床试验患者较少）。使用时，需要与乐天医疗的BioBlade激光系统医疗器械联合使用。获准6个月后，开始正式的首次临床应用。药融云数据，www.pharnexcloud.com；改名后为摩熵医药数据本品为冻干粉制剂，规格为250 mg/瓶-5mg/mL  ；缓冲液类型缓冲盐：10mM 磷酸盐，pH7.1；赋形剂：90mg/mL海藻糖；表面活性剂：0.2mg/mL吐温80。由于精力与资金有限，公司策略性选择ASP-1929开展仅2项全球多中心3期临床试验，即针对局部晚期或复发性头颈癌和与PD-1联用的一线临床试验；ClinicalTrials.gov (登记号为NCT03769506) 和 ClinicalTrials.gov (登记号为NCT06699212)，于2025年1月3日宣布启动。乐天医药开发的光免疫疗法，涉及的靶点还有CD25,PD-L1；HER2,MUC1,CEA，PSMA等。其他公司在开发光免疫疗法ADC的靶点有：TROP-2,VEGFR2等。 附分享：特色企业乐天医药早年PPT。发送 乐天（请正确复制）至下方 药融圈 微信公众号后台可获得原文件。仅供学习交流分享！参考：NMPA/CDE；摩熵医药数据pharma.bcpmdata.com（原药融云数据）；FDA/EMA/PMDA；https://rakuten-med.com/us/news/press-releases/2025/01/23/7878/；https://rakuten-med.com/us/news/press-releases/；https://clinicaltrials.gov/study/NCT03769506；Karkinos Healthcare and Rakuten Medical collaborate to develop cancer treatments in India；https://news.yahoo.co.jp/articles/a7690d0e5aac63b00d391c77adac86c990533529； Transnasal photoimmunotherapy with cetuximab sarotalocan sodium: Outcomes on the local recurrence of nasopharyngeal squamous cell carcinoma. Auris Nasus Larynx. 2022 Jun 29:S0385-8146(22)00167-5. doi: 10.1016/j.anl.2022.06.004.. PMID: 35779979；等等。此文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐。更多药企信息交流或合作可后台留下名片。会议推荐 | 点击查看详情植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐

SAN DIEGO, CA, USA I January 23, 2025 I Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting Alluminox™ platform-based photoimmunotherapy, today announced the initiation of its global multi-regional Phase 3 clinical trial evaluating ASP-1929 photoimmunotherapy in combination with anti-PD-1 (pembrolizumab) as a first-line therapy for recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 / Acronym: ECLIPSE* / ClinicalTrials.gov Identifier: NCT06699212 ). The first patient in this trial recently received a study treatment at the Avera Cancer Institute in Sioux Falls, South Dakota, USA. Alongside the U.S., patient enrollment is slated for sites in Japan and Taiwan, followed by additional countries and regions. The ASP-1929-381 study is a multi-regional multi-center, randomized, open-label Phase 3 trial, designed to assess the efficacy and safety of ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for locoregional recurrent HNSCC without distant metastases. Approximately 400 patients globally will be randomized to either an experimental arm receiving ASP-1929 photoimmunotherapy in combination with pembrolizumab, or a control arm receiving the current pembrolizumab-based standard of care (SOC), where patients may receive pembrolizumab alone or in combination with chemotherapy according to the physician’s choice. The primary endpoint is Overall Survival (OS), with key secondary endpoints including Complete Response Rate (CRR) and Overall Response Rate (ORR). This study builds on data from an interim evaluation (data cut-off: August 31, 2023) of 19 patients enrolled in the HNSCC cohort of a prior Phase 1b/2 study (ASP-1929-181 study / ClinicalTrials.gov Identifier: NCT04305795 ). The data showed an estimated 24-month survival rate of 52.4%, with a median OS not yet reached, and a generally tolerated safety profile. Head and neck cancer ranks as the 7 th most common cancer globally with over 90% classified as squamous cell carcinoma 1 . More than 60% of HNSCC patients present with locally or regionally advanced disease (stage III or IV) 1 . Of these, 15-40% will experience recurrence, facing a poor prognosis and a 5-year overall survival rate of less than 50% 1 . Dr. Kristen Coffroth, MD of Avera Medical Group Ear, Nose & Throat – Head and Neck Surgery, and one of the investigators for the ASP-1929-381 study at the Avera Cancer Institute, stated, “Photoimmunotherapy has a unique mode of action, which involves a biophysical disruption of targeted cells. Pembrolizumab has become a mainstay in systemic treatment for recurrent/metastatic HNSCC. This trial will evaluate whether the combination of ASP-1929 photoimmunotherapy with pembrolizumab can harness synergistic antitumor effects, which may shed new light on the treatment of locoregional recurrent HNSCC.” Dr. William Chad Spanos, MD, FACS of Avera Medical Group Ear, Nose & Throat – Head and Neck Surgery, and Principal Investigator for the ASP-1929-381 study at the Avera Cancer Institute, added, “I am impressed by the technology behind photoimmunotherapy, which offers a novel and targeted approach to cancer treatment. Combining this with pembrolizumab has the potential to expand first-line treatment options for patients with recurrent HNSCC. I am pleased to initiate this groundbreaking trial at our site and look forward to contributing to advancing care for patients facing this challenging disease.” Mickey Mikitani, Chief Executive Officer and Vice Chairman of the Board of Rakuten Medical, concluded, “The initiation of this global Phase 3 trial marks a significant milestone in our journey to contribute to the treatment and lives of patients with head and neck cancer and potentially others affected by cancer. With encouraging data from Phase 1b/2 study, we are optimistic about the potential of ASP-1929 photoimmunotherapy combined with pembrolizumab to improve treatment outcomes in recurrent head and neck cancer.” Disclaimer: Rakuten Medical’s Alluminox™ platform-based photoimmunotherapy is investigational outside Japan. * ECLIPSE: E liminating C ancer with L aser I llumination and P hoto SE nsitizer About Rakuten Medical Rakuten Medical, Inc. is a global biotechnology company developing and commercializing precision, cell-targeting 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 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 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 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 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 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. OURCE: Rakuten Medical