SSTR2 positive Gastro-Enteropancreatic Neuroendocrine Tumor

225Ac-Satoreotide is a first-in-class somatostatin receptor 2 antagonist targeting extensive stage small cell lung cancer and is the first antagonist labelled with 225Ac to enter clinical development Satoreotide expressed a superior pharmacokinetic profile relative to DOTA-TATE with a higher pre-clinical anti-tumour efficacy, irrespective of radionuclide used 100% survival with a single dose of 30 kBq 225Ac-satoreotide but not with 225Ac-DOTA-TATE BERLIN, Oct. 22, 2024 /PRNewswire/ -- Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announces that it presented data on its proprietary radiolabelled peptide SS0110 (satoreotide), a first-in-class antagonist of the somatostatin receptor 2 (SSTR2), at this year's European Association of Nuclear Medicine (EANM) Annual Conference, held in Hamburg, Germany from 19-23 October 2024. The Top-Rated Oral Presentation (TROP) entitled '225Ac-SSO110 induces long-lasting anti-tumour responses in contrast to 225Ac-DOTA-TATE and 161Tb-DOTA-TATE in the treatment of SSTR2-positive tumour xenografts', details the anti-tumour efficacy of different radiolabelled satoreotide antagonists (225Ac, 161Tb, 177Lu-labelled SSO110) versus respective DOTA-TATE agonists (225Ac- and 161Tb-labelled DOTA-TATE) in mice engrafted with SSTR2 positive xenografts of small cell lung cancer (SCLC) and pancreatic cancer using clinically relevant associated dose ranges. Results demonstrate that 225Ac-satoreotide shows the strongest anti-tumoural effect in vivo at a low single dose when evaluating satoreotide and DOTA-TATE radiolabelled with different radionuclides. Irrespective of the radionuclides used, satoreotide demonstrated a higher pre-clinical anti-tumour efficacy when compared to DOTA-TATE which was less potent and required increased dose levels. Satoreotide was well tolerated across all dose levels and with all used radionuclides. These comparisons between satoreotide and DOTA-TATE will facilitate and guide further clinical development of satoreotide across multiple indications expressing SSTR2, such as SCLC, pancreatic cancers and Merkel Cell Carcinoma (MCC). Previous comparisons between satoreotide and DOTA-TATE demonstrated that antagonist, 225Ac-satoreotide, is multiple times more potent than SSTR2 agonist, 225Ac-DOTA-TATE, signifying a durable complete response in standard murine xenograft models of SCLC in animal models, versus tumour growth delay. Ariceum had previously shown at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting 2024 that 212Pb was not seen to be more potent than Lutetium or Terbium but caused more side effects and hence was not further pursued. Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "These results provide strong evidence for satoreotide and its potential to clinically outperform SSTR2 targeting agonists, by demonstrating significantly better efficacy in tumour growth control, up to complete tumour eradication depending on isotope used. In addition, when a single dose of 30 kBq 225Ac-satoreotide was administered, we observed high frequency of complete durable responses and 100% survival which strongly supports further clinical development for the treatment of SCLC, MCC and other cancers." Details of the oral presentation are as follow: Title: 225Ac-SSO110 induces long-lasting anti-tumour responses in contrast to 225Ac-DOTA-TATE and 161Tb-DOTA-TATE in the treatment of SSTR2-positive tumour xenografts Presenting Author: Prachi Desai, Scientist at Ariceum Therapeutics Session Number: 1204 Session Title: M2M Track - TROP Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation Oral Presentation Date & Time: Tuesday 22 October 2024, 09:00 AM – 09:10 AM CEST Abstract Authors: Prachi Desai, Manuel Sturzbecher-Hoehne, Dennis Mewis, Manfred Ruediger & Anika Jaekel of Ariceum Therapeutics Session Date & Time: Tuesday 22 October 2024, 08:00 AM – 09:30 AM CEST Location: Session Hall X1-X4 Abstracts are available in the September edition of Springer's European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) abstract book here and on the Ariceum website here. About Ariceum Therapeutics Ariceum Therapeutics (Ariceum) is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of 'Marie Curie' whose discovery of radium and polonium have been huge contributions to finding treatments for cancer. Ariceum's lead targeted systemic radiopharmaceutical product, 177Lu-satoreotide tetraxetan ("Satoreotide"), is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), or Merkel Cell Carcinoma (MCC), all of which have few treatment options and poor prognosis. Satoreotide is being developed as a 'theranostic' pair for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), currently in Phase 1 clinical development under the trial name CITADEL-123. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023. Ariceum Therapeutics, launched in 2021, acquired all rights to Satoreotide from Ipsen. Ipsen remains a shareholder in the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, United Kingdom and United States of America and with activities currently across the globe. Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners and Earlybird Venture Capital. For further information, please visit . About European Association of Nuclear Medicine (EANM) The European Association of Nuclear Medicine (EANM) is a non-profit organization that promotes nuclear medicine and aims to improve public health. The EANM's mission is to advance nuclear medicine through personalized healthcare, innovation in diagnosis and treatment, and raising awareness of nuclear medicine SOURCE Ariceum Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SST2 antagonist, 225Ac-SSO110 (satoreotide), is multiple times more potent than SST2 agonist, 225Ac-DOTATATE Satoreotide demonstrated durable complete response in standard murine xenograft models of Small Cell Lung Cancer in animal models, versus tumor growth delay with 225Ac-DOTATATE BERLIN, June 10, 2024 /PRNewswire/ -- Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announces that it will be presenting a poster demonstrating the efficacy of its somatostatin receptor 2 (SST2) antagonist, SS0110 (satoreotide), relative to SST2-targeting agonists, at this year's Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held 8-11 June 2024 in Toronto, Canada. The poster presentation entitled '[225Ac]Ac-SSO110 and [177Lu]Lu-SSO110 demonstrate significantly better efficacy than [225Ac]Ac-DOTA-TATE in the treatment of SST2-positive tumor xenografts' compares satoreotide with the SST2 agonist, 225Ac-DOTATATE, and reveals that single doses of 20 MBq 177Lu-satoreotide or 30 kBq 225Ac-satoreotide induce significantly better efficacy than a single dose of 30 kBq 225Ac-DOTATATE. Most remarkably, 30 kBq 225Ac-satoreotide induced complete tumor regression in the NCI-H69 model, something not observed with the same or higher doses of 225Ac-DOTATATE. These data highlight the significantly higher tumor uptake and longer tumor retention leading to a higher tumor to background and tumor to kidney ratios of satoreotide which translates into higher pre-clinical efficacy than SST2-targeting agonists when labelled with isotopes, 225Ac-satoreotide and 177Lu-satoreotide. This demonstrates the potential for satoreotide to clinically outperform SST2-targeting agonists and strongly supports its further clinical development for the treatment of SST2 positive tumors such as Small Cell Lung Cancer (SCLC) and Merkel Cell Carcinoma (MCC). Manfred Rüdiger, Chief Executive Officer at Ariceum Therapeutics, said: "With this significant data we demonstrate that satoreotide has the potential to be a game changer for the treatment of SCLC and MCC. Satoreotide is multiple times more potent than DOTATATE, irrespective of the isotope, and this confirms the superiority of SST2 antagonist over agonist. We look forward to presenting our findings at this year's SNMMI meeting." Details of the poster presentation are as follow: Title: [225Ac]Ac-SSO110 and [177Lu]Lu-SSO110 demonstrate significantly better efficacy than [225Ac]Ac-DOTA-TATE in the treatment of SST2-positive tumor xenografts Authors: Anika Jaekel, Prachi Desai, Germo Gericke, Manuel Sturzbecher-Hoehne, Dennis Mewis & Manfred Rüdiger Presenter: Anika Jaekel, Senior Director, Head of Translational Biology and Non-Clinical Pharmacology at Ariceum Therapeutics Session: MTA07 POPs/Meet the Author: Oncology, Basic & Translational 2 Session Date and Time: Monday, June 10, 2024, 10:00 - 11:15 DST Abstract ID: 242038 About Ariceum Therapeutics Ariceum Therapeutics (Ariceum) is a private, clinical stage radiopharmaceutical company focused on the diagnosis and precision treatment of certain neuroendocrine and other aggressive, hard-to-treat cancers. The name Ariceum is an anagram of 'Marie Curie' whose discovery of radium and polonium have been huge contributions to finding treatments for cancer. Ariceum's lead targeted systemic radiopharmaceutical product, 177Lu-satoreotide tetraxetan ("Satoreotide"), is an antagonist of the somatostatin type 2 (SSTR2) receptor which is overexpressed in neuroendocrine tumours (NETs) and some aggressive cancers such as small cell lung cancer (SCLC), or Merkel Cell Carcinoma, all of which have few treatment options and poor prognosis. Satoreotide is being developed as a 'theranostic' pair for the combined diagnosis and targeted radionuclide treatment of these tumours. Ariceum is also developing a radiolabelled PARP-inhibitor (ATT001), which is slated to enter clinical development in 2024. ATT001 was part of the acquisition of Theragnostics Ltd which was closed in June 2023. Ariceum Therapeutics, launched in 2021, acquired all rights to Satoreotide from Ipsen. Ipsen remains a shareholder in the Company. Ariceum is headquartered in Berlin, with operations in Germany, Switzerland, Australia, United Kingdom and United States of America and with activities currently across the globe. Ariceum is led by a highly experienced management team and supported by specialist investors including EQT Life Sciences (formerly LSP), HealthCap, Pureos Bioventures, Andera Partners and Earlybird Venture Capital. For further information, please visit . About SNMMI The Society of Nuclear Medicine and Molecular Imaging (SNMMI), headquartered in Reston, VA, is a nonprofit scientific and professional organization that promotes the science, technology and practical application of nuclear medicine and molecular imaging. SOURCE Ariceum Therapeutics

▎药明康德内容团队编辑根据中国国家药监局药品审评中心（CDE）官网数据，本周有约20款1类新药首次获得临床试验默示许可。通过梳理，这些新药涵盖多款抗体偶联药物（ADC）、核药、抗体类药物、细胞治疗药物、小分子药物等，拟用于治疗银屑病、肺动脉高压、抑郁症、儿童生长激素缺乏症、2型糖尿病、超重或肥胖以及多种肿瘤疾病等。本文将对其中部分产品进行简要介绍，仅供读者参阅。恒瑞医药：HRS9531片作用机制：GIPR和GLP-1R双激动剂适应症：超重或肥胖、2型糖尿病根据恒瑞医药公开资料，HRS9531片是新型口服多肽GIPR和GLP-1R双激动剂，拟用于治疗2型糖尿病和减重。HRS9531注射液剂型已经在中国进入治疗超重或肥胖的3期临床研究阶段。本次该产品的片剂剂型在中国获批临床，拟用于治疗超重或肥胖、2型糖尿病。值得一提的是，几天前（5月16日），恒瑞医药刚刚宣布与美国Hercules公司达成一项超60亿美元合作，后者将获得在除大中华区以外的全球范围内开发、生产和商业化GLP-1产品组合的独家权利，其中就包括了HRS9531注射液和口服产品。宜联生物：注射用YL211、注射用YL205作用机制：靶向c-Met的ADC、靶向NaPi2b的ADC适应症：晚期实体瘤、晚期实体瘤根据宜联生物公开资料，YL211是特异性靶向c-MET的新型ADC，采用了宜联生物的新一代、肿瘤微环境可激活的新型毒素连接子平台技术。今年1月，宜联生物已经与罗氏（Roche）达成一项超10亿美元的合作，后者获得YL211项目在全球范围内的开发、制造和商业化的独家权益。该药本次在中国获批临床，拟开发治疗晚期实体瘤。YL205是特异性靶向NaPi2b的下一代抗体偶联药物（ADC），以新型拓扑异构酶I抑制剂为有效载荷。NaPi2b是一种细胞表面钠依赖性磷酸盐转运蛋白，在高级别浆液上皮性卵巢癌、输卵管癌和原发性腹膜癌等多种癌症中表达，而在正常组织中表达有限，因此其有望作为癌症治疗的靶点。艾伯维（AbbVie）：ABBV-400注射用粉末作用机制：靶向c-Met的ADC适应症：局部晚期/转移性结直肠癌根据艾伯维公开资料，ABBV-400是一种靶向c-Met的ADC，有效载荷为TOP1i，拟开发用于治疗c-Met阳性实体瘤。该产品正在国际范围内开展1期临床研究，本次在中国获批临床的适应症为不可切除的局部晚期/转移性结直肠癌。Servier公司：vorasidenib片作用机制：IDH1/2抑制剂适应症：星形细胞瘤或少突胶质细胞瘤公开资料显示，vorasidenib片是一款口服具脑渗透性与选择性的双重抑制剂，可抑制突变的易感基因异柠檬酸脱氢酶（IDH1/2）蛋白。该药本次获批临床的适应症为：用于成人和12岁及以上儿童手术干预后伴有IDH1/2突变的以非增强为主的星形细胞瘤或少突胶质细胞瘤的患者的治疗。值得一提的是，今年2月，vorasidenib用以治疗IDH突变神经胶质瘤患者的新药申请（NDA）已经获美国FDA受理并授予优先审评资格。科兴生物：GB08注射液作用机制：长效化生长激适应症：儿童生长激素缺乏症根据科兴生物此前公告，GB08注射液是其自主研发的Fc融合蛋白长效化生长激素，本次获批临床的适应症为儿童生长激素缺乏症。科兴生物通过DNA重组技术，将人生长激素（hGH）基因与IgG4 亚型Fc段基因连接后表达，显著提高了产品安全性及患者的用药便利性和依从性。上海医药：SPH7450片（I040）作用机制：小分子化合物适应症：抑郁症根据上海医药公告，I040是一款小分子化合物，本次获批临床的适应症为抑郁症。临床前研究显示其能在多个抑郁症动物模型上起到改善核心症状的效果，且安全性较佳。蓝纳成生物：177Lu-LNC1010注射液作用机制：放射性标记的生长抑素类似物适应症：胃肠胰神经内分泌瘤根据蓝纳成生物公开资料，177Lu-LNC1010注射液是一种靶向生长抑素受体2（SSTR2）的放射性体内治疗药物。在核药开发领域，靶向生长抑素受体（SSTR）的放射性药物的开发代表了一种重要进展，而生长抑素类似肽的内化特性使放射性同位素递送至肿瘤细胞成为可能。177Lu-LNC1010注射液本次获批临床，适用于治疗SSTR2阳性的胃肠胰神经内分泌瘤（GEP-NETs)。新斗生物：DGPR1008注射液作用机制：靶向荧光造影剂适应症：前列腺癌根据新斗生物新闻稿介绍，DGPR1008注射液是该公司首款靶向荧光造影剂，针对前列腺癌，可在术中实时点亮肿瘤。该产品通过靶向肿瘤细胞，从而达到术中实时荧光成像的目的，从而可以辅助医生精准判定阳性切缘，实现彻底切除肿瘤病灶，极大减少对正常组织的损伤。该药获批临床适用于前列腺癌手术患者，作为术中识别恶性病变的辅助手段。康蒂尼药业：F230片作用机制：选择性内皮素受体拮抗剂适应症：肺动脉高压公开资料显示，康蒂尼药业创立于2002年，是美国Gyre Therapeutics的子公司，以器官纤维化疾病为核心开发创新药。根据康蒂尼药业官网资料，F230片为一款选择性内皮素受体（ETA）拮抗剂，拟开发治疗罕见病肺动脉高压。选择性阻断ETA能够阻断由内皮素引起的血管收缩，发挥降压作用，改善血液动力学和运动能力，从而用于治疗肺动脉高压。后者是一种罕见、进行性、危及生命的血管疾病，其特征为肺小动脉收缩和肺循环中血压升高。亿诺药业：INNA1605软膏作用机制：小分子MyD88抑制剂适应症：银屑病根据亿诺药业新闻稿，INNA1605软膏为该公司自主研发的一种小分子MyD88抑制剂，拟开发多种由自身免疫引起的皮炎，如银屑病、特应性皮炎、过敏性皮炎等。本次该药获批临床的适应症为银屑病。MyD88抑制剂是一类针对先天免疫系统中TLR/MyD88信号通路的小分子抑制剂，MyD88是处于人体免疫系统源头，在众多免疫性疾病的发生和发展中至关重要。基因泰克：vixarelimab注射液作用机制：抗OSMRβ单抗适应症：溃疡性结肠炎根据公开资料，vixarelimab（RG6536）是罗氏（Roche）旗下基因泰克（Genentech）公司在研的一款潜在“first-in-class”阻断抑瘤素M受体β（OSMRβ）的全人源单克隆抗体，它可阻断OSM和IL-31信号传导，同时保留通过LIFR通路的信号传导。该产品治疗结节性痒疹相关瘙痒适应症此前已经被FDA授予突破性疗法认定。本次该药在中国获批临床的适应症为溃疡性结肠炎。恩凯赛药：NK042细胞注射液作用机制：通用型基因修饰NK细胞注射液适应症：晚期实体瘤根据恩凯赛药新闻稿介绍，NK042是异体外周血来源的通用型基因修饰NK细胞注射液，具备治疗实体瘤、血液肿瘤及非肿瘤类疾病的潜力。此次获批的1期临床针对适应症为晚期实体瘤。舜喜再生医学：SCM-181注射液作用机制：人胎盘绒毛膜间充质干细胞注射液适应症：特发性肺纤维化根据舜喜再生医学新闻稿介绍，SCM-181注射液是一款来源于人胎盘绒毛膜的间充质干细胞（hPC-MSC）。相较其他来源的间充质干细胞，胎盘绒毛膜间充质干细胞有着来源丰富、采集便捷、免疫原性低，以及更高的增殖能力等优点。该产品获批临床的适应症为特发性肺纤维化。除了上述产品，本周还有其他1类新药获批临床，或获批针对新适应症开展临床研究，限于篇幅， 此处不再一一赘述。希望这些1类新药后续临床研究进展顺利，早日取得突破，造福患者。参考资料：[1]中国国家药监局药品审评中心（CDE）官网.Retrieved May 25，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]各公司官网及公开资料本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。