Adenocarcinoma of Esophagus

VADUZ, Liechtenstein, March 27, 2024 /PRNewswire/ -- Implantica AG (publ.), a medtech company at the forefront of bringing advanced technology into the body, announces the submission of the first module of the PMA application to the U.S. FDA for RefluxStop®, an innovative device for the treatment of Gastroesophageal Reflux Disease (GERD). The U.S. FDA has agreed to a modular submission process for the RefluxStop PMA application. This process provides for ongoing review and feedback from the FDA as the modules are submitted. The second and third (final) modules are anticipated to be submitted to the FDA in three-month intervals later this year. An estimated 27% of the adult population in the U.S. struggle with GERD1 and 40% of GERD patients don't respond to PPIs, the most common medication to treat the disease.2 This leaves tens of millions of patients with limited options to treat the relentless, painful symptoms of GERD. Even worse, in the U.S. and EU, around 48,000 people die annually from esophageal adenocarcinoma, with strong indications in the literature to be caused by acid reflux. Dr. Peter Forsell, CEO of Implantica, says, "This FDA filing is a key fundamental milestone for RefluxStop®3 and puts us in motion for the U.S. launch preparation ahead of the pending FDA approval. The basis for this expedited submission is the extraordinary 5-year clinical results from the RefluxStop CE mark study. Furthermore, more than 750 patients have been treated with the RefluxStop procedure in Europe, and the clinical outcome during the commercialization process has been in line with the CE study results." Dr. Forsell continues, "The broader interest and acceptance for RefluxStop has been phenomenal so far and continues to grow rapidly among the leading European surgeons and Reflux centers of excellence, driven by exceptional patient outcomes and the larger medical community's support. With the recently announced completion of the US Human Factors study, a crucial milestone for PMA application, we are gearing up to file the next FDA module in three months time and are looking forward to bringing RefluxStop® to the U.S. market." Reference: Antunes C, Aleem A, Curtis SA. Gastroesophageal Reflux Disease. [Updated 2023 Jul 3]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: Kahrilas PJ, Boeckxstaens G, Smout AJ. Management of the patient with incomplete response to PPI therapy. Best Pract Res Clin Gastroenterol. 2013 Jun;27(3):401-14. doi: 10.1016/j.bpg.2013.06.005. PMID: 23998978; PMCID: PMC3761380. RefluxStop® is a registrated trademark in the U.S. For further information, please contact: Nicole Pehrsson, Chief Corporate Affairs Officer Telephone (CH): +41 (0)79 335 09 49 [email protected] Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. The company's Certified Adviser is FNCA Sweden AB, [email protected] The information was sent for publication, through the agency of the contact person set out above, on March 27, 2024, at 08:00 a.m. (CET). About Implantica Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica's lead product, RefluxStop™, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energizing platform designed to power remote-controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). Visit for further information. About RefluxStop™ RefluxStop™ is a new innovative treatment that has the potential to spur a paradigm shift in anti-reflux surgery. It's unique mechanism of action differentiates it from standard of care and current surgical solutions. Longer established surgical options for GERD involve encircling the food passageway to support the lower esophageal sphincter's closing mechanism and are commonly associated with side effects such as swallowing difficulties, pain when swallowing and inability to belch and/or vomit. In contrast, the RefluxStop device treats the cause of acid reflux without encircling and putting pressure on the food passageway. It restores and maintains the lower esophageal sphincter in its original, natural position. The RefluxStop™ mechanism of action is focused on reconstructing all three components of the anti-reflux barrier, that if compromised could possibly result in acid reflux. It restores and supports the natural anatomical physiology of the body allowing the body to itself solve the problem with acid reflux. Newsroom Community Media Contact: Implantica AG Juanita Eberhart, VP Marketing & Advocacy M: +1 925-381-4581 [email protected] This information was brought to you by Cision The following files are available for download:

VADUZ, Liechtenstein, March 26, 2024 /PRNewswire/ -- Implantica AG (publ.), a medtech company at the forefront of bringing advanced technology into the body, announces completion of the Human Factors Validation Study with 16 US surgeons as part of the US FDA Premarket Approval (PMA) process for RefluxStop™. In March, 16 foregut surgeons in the United States (U.S.) participated in a Human Factors Validation Study of the RefluxStop™ procedure at Northwestern University's Simulation Lab in Chicago. RefluxStop™ is an innovative new surgical procedure for the treatment of gastroesophageal reflux disease (GERD). The goal of the study is to demonstrate how surgeons at varying levels of surgical experience from academic, community, and private clinics in the US, carry out the RefluxStop™ procedure. In the next step of the study, an independent third party is evaluating the data collected during testing in Chicago. Findings are included in Implantica's application for an FDA PMA for RefluxStop™. The completion of this Human Factors study marks a critical milestone, which Implantica hopes will significantly help advance the US market approval process and ultimately result in the widespread availability of RefluxStop™ in the US. Dr. Peter Forsell, CEO of Implantica, says, "We're very grateful to the independent US surgeons and healthcare professionals who participated in the Human Factors Validation study, a key milestone for the FDA approval process. We extend our sincere thanks to each one of the participants for their commitment and support in bringing RefluxStop™, a disruptive surgical treatment for GERD, to patients in the U.S. An estimated 27% of the adult population in the United States struggle with GERD1 and 40% of GERD patients don't respond to PPIs, the most common medication to treat the disease.2 This leaves tens of millions of patients with limited treatment options to treat the relentless, painful symptoms of GERD and even worse, 48'000 people die in esophageal adenocarcinoma in the US and EU alone, with strong indications in the literature to be caused by acid reflux. Over 750 cases of the RefluxStop™ procedure have now been conducted in Europe with great success and RefluxStop™ fills a very strong unmet need for GERD patients in the US and around the world." Reference: 1. Antunes C, Aleem A, Curtis SA. Gastroesophageal Reflux Disease. [Updated 2023 Jul 3]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: 2. Kahrilas PJ, Boeckxstaens G, Smout AJ. Management of the patient with incomplete response to PPI therapy. Best Pract Res Clin Gastroenterol. 2013 Jun;27(3):401-14. doi: 10.1016/j.bpg.2013.06.005. PMID: 23998978; PMCID: PMC3761380. For further information, please contact: Nicole Pehrsson, Chief Corporate Affairs Officer Telephone (CH): +41 (0)79 335 09 49 [email protected] Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm. The company's Certified Adviser is FNCA Sweden AB, [email protected] The information was sent for publication, through the agency of the contact person set out above, on March 26, 2024, at 08:00 a.m. (CET). About Implantica Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica's lead product, RefluxStop™, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energizing platform designed to power remote-controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). Visit for further information. About RefluxStop™ RefluxStop™ is a new innovative treatment that has the potential to spur a paradigm shift in anti-reflux surgery. It's unique mechanism of action differentiates it from standard of care and current surgical solutions. Longer established surgical options for GERD involve encircling the food passageway to support the lower esophageal sphincter's closing mechanism and are commonly associated with side effects such as swallowing difficulties, pain when swallowing and inability to belch and/or vomit. In contrast, the RefluxStop device treats the cause of acid reflux without encircling and putting pressure on the food passageway. It restores and maintains the lower esophageal sphincter in its original, natural position. The RefluxStop™ mechanism of action is focused on reconstructing all three components of the anti-reflux barrier, that if compromised could possibly result in acid reflux. It restores and supports the natural anatomical physiology of the body allowing the body to itself solve the problem with acid reflux. Newsroom Community Media Contact: Implantica AG Juanita Eberhart, VP Marketing & Advocacy M: +1 925-381-4581 [email protected] This information was brought to you by Cision The following files are available for download:

置身当下ADC的竞逐赛，艾伯维终于得到一个极大的利好：FDA将Elahere的加速批准转为完全批准。Elahere的完全获批，无疑开了一个好头，让艾伯维有了更多的底气。01一个抓手卵巢癌被称作“妇癌之王”，是女性生殖系统中最难诊断、最恶性、死亡率最高的疾病。通过标准的减瘤手术联合铂类药物，是卵巢癌基础的治疗方案，虽然大多晚期患者对治疗有响应，但70%的患者仍会复发，五年生存率不足40%，且复发患者较易产生铂类耐药问题。研究发现，FRα在卵巢癌上有非常优异的表达，采用ADC形式靶向FRα的尝试，最终在Elahere上开花结果。2022年11月，Elahere获得FDA批准加速上市，用于FRα阳性、铂耐药上皮卵巢、输卵管或原发性腹膜成人癌症患者的治疗。Elahere的成功与药物设计密不可分。有从业者表示，Elahere选择的毒素为DM4，linker为可裂解连接子。在临床前的动物模型中，无论是表达高低，以DXD为payload的ADC都展现了不错的效果。本次完全批准基于验证性MIRASOL的临床III期试验，该试验支持Elahere作为FRα阳性铂类耐药卵巢癌的潜在新标准。数据显示，Elahere治疗带来了OS获益，并将癌症进展的风险降低了35%。试验结果显示，与IC化疗对照组相比，Elahere的3+级不良事件总体较少，不良事件导致的停药率较低。换言之，Elahere是首个在铂类耐药卵巢癌患者上显示带来OS改善的疗法。这一定程度推动了它的商业化进程。Elahere自加速批准上市后放量迅速，2023年第一季度的销售额为2950万美元，第二季度为7740万美元，第三季度净销售额为1.052亿美元——前9个月累计销售额达到2.12亿美元，极具增长潜力，势必为艾伯维冲击ADC市场提供强力“武器”。根据艾伯维官网，Elahere目前主要的适应症聚焦在卵巢癌领域，有关铂类敏感性卵巢癌的研究正处在临床III期阶段。而ImmunoGen此前的规划显示，Elahere的销售额将通过各种联用尝试，随着覆盖患者的扩大而增加。2023年8月，ImmunoGen宣布就Elahere与武田达成合作。值得注意的是，早在2020年10月，ImmunoGen已这款药物的大中华区权益授权给华东医药，获得4000万美元的首付款以及最高可能达2.65亿美元的里程碑付款。本土同样在布局FRαADC的Biotech，包括百奥泰、普方生物。其中，普方生物开发的Rina-S目前正处于针对多种实体肿瘤的临床I/II期开发阶段。百奥泰旗下BAT8006也尚在早期临床。02一张宏图从并购交易额上看，预计今年年中完成ImmunoGen的案例，算是近年艾伯维少有的大手笔。再往前，则是2019年对艾尔建的630亿美元并购。考虑到眼下“药王”Humira失势的阵痛，重金砸向外部，实属一个不得不做的决定。当然，有限的资金盘子里，势必要做出一番调整。高调宣告抢占ADC领域机会的同时，艾伯维也做了很多减法。到去年下半年，艾伯维接连将ABBV-154、ABBV-011、ABBV-647从管线中划去，加上此前放弃的资产，艾伯维抛弃的ADC多达7款。纵观艾伯维在2023年的动作，不难看出其着重在调整肿瘤领域。2023年财报显示，这家MNC全年净收入543.18亿美元，同比下降6.4%，实现净利48.63亿美元，同比下降58.91%。作为艾伯维聚焦的5大疾病领域之一，肿瘤学领域的贡献不算亮眼，去年业绩下滑10.1%，跌破60亿美元门槛。艾伯维抗肿瘤版图的营收，主要来自Imbruvica和Venclexta，前者由于BTK赛道的激烈竞争和安全性风波，市场份额在大幅流失；后者作为全球上市的唯一一款Bcl-2抑制剂，增长良好，2023年同比增长13.9%，达22.88亿美元。去年5月，艾伯维成功将CD3/CD20双抗Epkinly推向市场，用于治疗接受过二线或多线系统治疗的复发或难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）患者，上市半年卖出3100万美元。不过，在CD20/CD3这个领域，罗氏是艾伯维避不开的直接对手，后者已拥有2款上市的双抗产品。要么首创抢占空白，要么做到最佳引领潮流——朴素的制药道理，在艾伯维身上得到印证。以此而言，追逐ImmunoGen的做法，便多少可以视作艾伯维的创新突破口。除了给艾伯维带来了极具前景的Elahere外，ImmunoGen还有一款处于I期临床的IMGN-151，也是用于治疗卵巢癌的新一代FRαADC，正在多项癌症类型中进行研究；处在II期临床的IMGN-632，则是一款靶向CD123的ADC，已被FDA授予突破性疗法认定，用于治疗复发/难治性母细胞性浆细胞样树突状细胞肿瘤（BPDCN）。这些外部资产，一定程度挽回了艾伯维在ADC领域的门面。毕竟几经调整后，它能拿得出手的创新产品所剩无几。艾伯维内部在研ADC管线中，当属进入全球注册性III期临床的ABBV-399能一骑绝尘。该药是目前全球唯一一款进入III期临床的c-Met靶向ADC，可针对肿瘤细胞表面的c-Met突变进行追踪，并释放一种名为甲基澳瑞他汀（MMAE）的抗有丝分裂药物来杀死癌细胞。2022年1月，ABBV-399被FDA授予突破性疗法资格，用于治疗晚期或转移性铂类治疗后进展的c-Met高表达EGFR野生型非鳞状NSCLC患者。就ABBV-399来说，过去一年也并非乏善可陈。2023年11月，艾伯维宣布了ABBV-399单臂II期LUMINOSITY试验的顶线结果。结果显示，c-Met高表达组的ORR为53.8%，c-Met表达水平中等组的ORR为25.0%。中位缓解持续时间分别为9个月和7.2个月，中位总生存期分别为14.6个月和14.2个月。为了抢占c-Met赛道的机遇，艾伯维还储备了一款下一代在研产品ABBV-400。去年的ASCO年会上，对外展示的早期多瘤种药物爬坡试验结果，显示出该药在转移性结肠癌的整体有效率为22%。目前，该疗法结直肠癌适应症已进入临床II期，肺癌和胃食管腺癌处于临床I期。这家置身转型过程的巨头，已经展示出抗肿瘤故事的冰山一角。但考虑到ADC从者众多，加上早期开发所需要穿越的“死亡之谷”，艾伯维还需砥砺前行。注：以上图片来源同写意来源 | 同写意（药智网获取授权转载）撰稿 | 写意君责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。商务合作 | 王存星 19922864877（同微信） 阅读原文，是受欢迎的文章哦