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Prophylactic administration of a selective COX-2 inhibitor reduces the volume of edema associated with photoimmunotherapy by 30-50% Reduced edema volume by 25%, even when administered post photoimmunotherapy Suggested the COX-2 inhibitor may manage edema without compromising anti-tumor efficacy SAN DIEGO, April 11, 2024 /PRNewswire/ -- Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox™ platform, today announced a poster presentation of its study to manage edema following photoimmunotherapy at the 115th Annual Meeting of the American Association for Cancer Research (AACR 2024) in San Diego, California, on April 8th, 2024. In the study presented in this poster, Rakuten Medical developed a mouse tumor model to assess edema following photoimmunotherapy and evaluated various steroidal and non-steroidal anti-inflammatory drugs (NSAIDs) for edema reduction using the model. As a result, a reduction in edema was observed when the selective COX-2 inhibitor meloxicam, one of NSAIDs, was administered before or after illumination of photoimmunotherapy (30-50% reduction with prophylactic administration, 25% reduction with post-illumination administration). It was also confirmed that the reduction in edema with meloxicam was not associated with a loss of therapeutic benefit based on measurement of tumor growth. Rakuten Medical's photoimmunotherapy consists of a drug and a laser light. In pre-clinical studies, local illumination results in highly selective and rapid necrosis of target cells such as tumors. Early clinical studies have shown a manageable safety profile for head and neck cancer.* However, edema is a commonly reported adverse event with severe laryngeal edema noted in some patients, and prophylactic tracheostomy is required if laryngeal edema threatens to obstruct the airway. Thus, new tools to manage edema are needed to reduce the burden on the patient. Based on the results of this study, Rakuten Medical will conduct further research to address the challenges of edema associated with photoimmunotherapy in clinical trials and in clinical practice. Key findings presented at AACR 2024 Title: Reduction in photoimmunotherapy-induced edema with COX-2 inhibition: Combatting clinically relevant adverse events without compromising efficacy Abstract Number: 1415 Abstract Link: Cohorts of mice bearing syngeneic LL/2 tumors engineered to express Ephrin A2 (EphA2) were administered an anti-EphA2 antibody conjugated to IR700 (conjugate) or saline control and illuminated with light. Control mice did not generate edema, but mice treated with conjugate plus light showed a light-dose dependent increase in edema volume which peaked at 6h post light delivery. Inflammatory cytokine and immune cell populations in the blood and tumor region were then evaluated at the onset (2h post-light), peak (6h), and resolution (24h) of the edema associated with photoimmunotherapy. The results showed a striking increase in neutrophils in the blood at the peak of edema formation (500-fold greater than control mice, n=10, p<0.0001) and a significant increase in IL-6 (n=5, p<0.001) and IL-10 (n=5, p<0.05), indicating the onset of a heightened inflammatory response. To address edema formation, the effect of steroids or NSAIDs including the selective COX-2 inhibitor meloxicam were evaluated. Results showed that steroids did not reduce edema volume. Meloxicam, one of the selective COX-2 inhibitors, on the other hand, resulted in a reduction in edema volume at all time points and light doses evaluated. Prophylactic administration (2h prior to light) of meloxicam resulted in a 30-50% reduction in edema at both 2h and 6h post-light illumination. Post-light administration (2h post light) of meloxicam resulted in a 25% reduction at 6h post-light illumination (all settings, n=10, p<0.0001). The reduction in edema with meloxicam did not have negative impact on tumor growth inhibition. * Cognetti DM, Johnson JM, Curry JM, et al. Phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma. Head Neck. 2021;43(12):3875-3887. doi:10.1002/hed.26885 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/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 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 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. Contact Us SOURCE Rakuten Medical, Inc.

TORL BioTherapeutics宣布完成了超额的1.58亿美元B2轮融资，获得的资金将用于推动该公司研发管线中的多款潜在“first-in-class”和“best-in-class”抗体偶联药物（ADC）的临床开发。此次融资由 Deep Track Capital 领投，全球领先的生物技术投资者包括 RA Capital Management、Perceptive Advisors 和 Avidity Partners 、Goldman Sachs Alternatives、UC Investments、Bristol Myers Squibb、Vertex Ventures HC、 Moore Strategy Ventures、Blue Owl Healthcare Opportunities 和 Perceptive Xontogeny Venture Fund 跟投，迄今为止总筹集的资金总额超过3.5 亿美元。本次B2轮融资的收益将用于该公司的主打在研疗法TORL-1-23，一款靶向CLDN 6的潜在“first-in-class”ADC，目前正在1期临床试验中接受评估，预计在今年下半年启动2期临床试验。这一临床试验旨在支持TORL-1-23的监管审评和潜在批准，用于治疗CLDN 6阳性，对含铂化疗耐药的卵巢癌。融资收益还将用于资助正在进行1期研究的TORL-2-307 项目，它是一款靶向CLDN 18.2的单克隆抗体和ADC。该公司的管线还包括用于治疗 CDH17+ 结直肠癌的 ADC疗法TORL-3-600，以及用于治疗 Delta 样非典型 Notch Ligand 1 (DLK1) 阳性实体瘤的 ADC疗法TORL-4-500。全球ADC赛道火热ADC药物已成为时下最热门的赛道之一，吸引了众多药企入局。目前全球已有15款ADC药物获批上市，分别是辉瑞的Mylotarg、Besponsa，罗氏的Kadcyla、Polivy，阿斯利康的Lumoxiti、Enhertu，Seagen/武田制药的Adcetris，Seagen/安塞泰来的Padcev，Seagen/Genmab的Tivdak，葛兰素史克的Blenrep，吉利德的Trodelvy，Rakuten Medical的Akalux，ADCTherapeutics的Zynlonta，荣昌生物的爱地希，以及ImmunoGen/华东医药的Elahere。治疗领域涉及淋巴瘤、白血病、乳腺癌、多发性骨髓瘤、乳腺癌、头颈癌、尿路上皮癌等。中国市场获批的ADC药物有7个，其治疗领域涉及血液肿瘤和实体瘤等多个治疗领域，主要用于晚期、复发/难治性及转移性肿瘤的治疗。ADC赛道投融资也呈现出欣欣向荣的发展态势，仅在2024年1-3月间，国内外已有13家ADC药企迎来了新一轮融资进展，融资轮次多处于早期，融资总额超80亿元。结语目前全球已有15款ADC药物获批上市，全球ADC市场有望以30%的高复合增速，由2022年79亿美元增至2030年647亿美元；国内ADC领域未来3-5年有一批优质的差异化产品上市，中国ADC市场有望由2022年8亿元增至2030年662亿元，CAGR高达72.8%。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。