The Microbiome Health Research Institute, Inc.

Dr. Kassam will lead Seed Health's clinical research and medical affairs, driving the development and validation of the company's microbiome health innovations and enhancing practitioner engagement BOSTON, April 24, 2024 /PRNewswire/ -- Seed Health, a microbiome science company, today announced the appointment of Zain Kassam, M.D., M.P.H., as Chief Medical Officer. An award-winning physician-scientist, Dr. Kassam has played a pivotal role in the advancement of microbiome science for over a decade. His extensive body of work includes over 200 peer-reviewed publications and abstracts, including in The New England Journal of Medicine, Nature Biotechnology, and Gastroenterology, and co-authoring international clinical practice guidelines. He has championed more than 30 Phase I-III clinical trials with top-tier academic institutions across multiple therapeutic areas. As Chief Medical Officer, Dr. Kassam will collaborate with Chief Scientific Officer, Dirk Gevers, Ph.D., to oversee Seed Health's R&D portfolio. He will expand the company's gut microbiome program and guide upcoming launches in the vaginal and skin microbiome sectors, as well as in brain health, metabolic health, and longevity. Continue Reading Zain Kassam, M.D., M.P.H. "I am inspired by Seed Health's unwavering commitment to scientific excellence for everyday health and its pioneering platform for microbiome innovation," said Dr. Kassam. "The convergence of Seed's comprehensive microbiome insights with robust clinical validation offers a unique opportunity to advance the next generation of microbiome interventions and make a true impact on human lives." Dr. Kassam will oversee Seed Health's clinical strategy, guiding the trajectory from discovery through go-to-market. Collaborating with Seed Health's scientific and clinical advisory boards, as well as healthcare practitioners, he will ensure the company's interventions meet the highest standards of clinical efficacy and directly address both practitioner and patient needs. Furthermore, Dr. Kassam will manage medical affairs, stewarding awareness of the microbiome's impact on health and enhancing the understanding of Seed's clinically validated products throughout the healthcare ecosystem. Before joining Seed Health, Dr. Kassam co-founded and was Chief Medical Officer at two foundational microbiome therapeutics companies, OpenBiome and Finch Therapeutics. At OpenBiome, he was instrumental in creating the first public stool bank, setting a new standard for safe fecal microbiota transplantation (FMT), and pioneering clinical research in the microbiome. His tenure at Finch Therapeutics was marked by remarkable growth, as he led two landmark positive Phase II trials, and led the company through its NASDAQ IPO. Dr. Kassam has served as a Scientific Advisory Board member for the American Gastroenterological Association Center for Gut Microbiome Research & Education, and Co-Chair of the Chief Medical Officer 360o Summit, where he facilitated knowledge translation to clinicians. "Dr. Kassam's work seamlessly bridges the gap between clinical practice and microbiome science, transforming scientific discovery into real-world applications," said Raja Dhir, Co-Founder of Seed Health. "With the leadership of Dr. Kassam, we will significantly expand the impact of our work, introducing innovations essential to the ecology of care and redefining excellence in microbial innovation." Dr. Kassam is the latest high-profile addition to Seed Health's scientific leadership team, joining Chief Scientific Officer Dr. Gevers, formerly of the Janssen Human Microbiome Institute. He will also collaborate closely with esteemed partner scientists such as immunologist Dr. Cezmi Akdis, pioneering vaginal microbiome scientist Dr. Jacques Ravel, computational biologist Dr. Eran Segal, and microbiome researcher Dr. Sarkis Mazmanian, known for his work on the gut-brain axis. This dynamic team reflects Seed Health's commitment to stewarding microbiome applications for human and planetary health. "Dr. Kassam's expertise in microbiome science will be instrumental in fully realizing the potential of our advanced platform," said Dr. Gevers. "His distinguished track record in clinical development and foundational research ensures that we can transform cutting-edge microbiome insights into practical, effective health solutions." Dr. Kassam holds an M.P.H. from Harvard University and has completed postdoctoral training at MIT. He was awarded his M.D. from Western University in London, Canada. Dr. Kassam completed his Internal Medicine and Gastroenterology training at McMaster University. Dr. Kassam has received numerous awards, including the 2020 Public Health Innovator Award from Harvard T.H. Chan School of Public Health, among the most prestigious awards for Alumni. Media Contact [email protected] About Seed Health Seed Health is a microbiome science company pioneering innovations in probiotics and living medicines to impact human and planetary health. Founded to realize the potential of the microbiome, our platform enables the translation of breakthrough science across a portfolio targeting health outcomes from infancy to aging. Our consumer innovations are commercialized under Seed®—an award-winning, science-first brand known for clinically validated innovations in probiotics. Our pipeline encompasses both indication-specific and preventive applications for gastrointestinal and digestive health, women's health, skin, pediatrics, mental health, metabolic function, and nutrition. Our environmental research is conducted under SeedLabs, which was founded to advance novel bacterial interventions to enhance biodiversity and restore ecosystems impacted by human activity. SOURCE Seed Health

美国粪便银行OpenBiome有一项非常诱人的奖励制度：如果你可以一周五天不间断捐献出合格的粪便，便能够在每次捐献后获得40美元的报酬外，额外获得50美元全勤奖励；而在中国香港的亚洲抑菌中心，每周提供3次粪便的捐献者，每月可获得报酬高达4800元。这并不是玩笑，粪便捐献唯一需要的是你的粪便是万里挑一的「健康好便」。 图1 OpenBiome粪便捐献标准（图源：[1]）11 月30日，FDA（U.S. Food and Drug Administration）批准了 Rebyota，这是FDA批准的首个粪便微生物群产品，粪便疗法将成现实。Rebyota 被批准用于预防18 岁及以上人群的艰难梭菌感染（Clostridioides difficile infection，CDI）复发。它适用于个体完成针对复发性 CDI 的抗生素治疗后使用。图2 FDA批准首款Rebyota（图源：FDA）“今天Rebyota的批准对于护理复发性艰难梭菌感染患者来说是一项重大进步，”FDA生物制品评估和研究中心主任、医学博士Paul Feuerstadt说道。“复发性CDI会影响个人的生活质量，也可能危及生命。作为FDA批准的第一个粪便微生物群产品，今天的批准代表了一个重要的里程碑，因为它提供了一个额外的批准选项来预防复发性CDI。”粪便微生物药品是救命良药艰难梭菌（Clostridium difficile，CD）是一种可引起CDI的细菌，CDI是一种可能危及生命的疾病，会导致腹泻和严重的结肠炎症。在美国，CDI每年导致15000-30000人死亡。肠道含有数百万种微生物，通常称为“肠道菌群”或“肠道微生物组”。某些情况下，例如服用抗生素治疗感染，可能会改变肠道微生物的平衡，从而导致艰难梭菌繁殖和释放毒素，导致腹泻、腹痛和发烧，在某些情况下，还会导致器官衰竭和死亡。其他可能增加CDI风险的因素包括年龄超过65岁、因病住院、免疫系统减弱和既往CDI病史。然而CDI康复后，可能会再次感染，甚至是多次感染！这种情况被称为复发性CDI。每次感染都会增加额外复发的风险，并且复发性CDI的治疗选择有限。粪便微生物群的管理被认为有助于肠道菌群的恢复，以防止CDI的进一步发作。Rebyota以单剂量直肠给药。Rebyota由合格人员捐赠的粪便制成。对捐赠者和捐赠的粪便进行了一组可传播病原体的检测，但是，由于Rebyota是由人类粪便制成的，因此可能存在传播传染原的风险。此外，Rebyota可能含有食物过敏原；该产品因食物过敏原而引起不良反应的可能性尚不清楚。Rebyota的安全性通过两项随机、双盲、安慰剂对照临床研究以及在美国和加拿大进行的开放标签临床研究进行评估。参与者有一次或多次CDI复发史。他们在完成CDI抗生素治疗后24至72小时接受了一剂或多剂Rebyota或安慰剂；参与者的CDI在收到Rebyota或安慰剂时得到控制。在这些研究中，978名18岁及以上的人至少接受了一剂Rebyota。在一项研究中，在180名Rebyota接受者中，与87名安慰剂接受者相比，接受一剂Rebyota后最常见的副作用是腹痛、腹泻、腹胀、胀气和恶心。Rebyota的有效性在一项随机、双盲、安慰剂对照、多中心研究的数据分析中得到评估。该分析包括177名接受一剂Rebyota的成年人和85名接受一剂安慰剂的成年人。它还纳入了另一项安慰剂对照研究的成功率，其中39名成人接受了一剂Rebyota和一剂安慰剂，43名成人接受了两剂安慰剂。成功预防复发性CDI被定义为在服用Rebyota或安慰剂后8周内没有出现CDI腹泻。在一项考虑了这两项研究的统计分析中，Rebyota组（70.6%）在8周内预防复发性CDI的总体估计成功率显著高于安慰剂组（57.5%）。首款粪便微生物疗法Rebyota标志着重要的里程碑Ferring在2018年收购了位于明尼苏达州的开发商Rebiotix时收购了Rebyota。“我们相信这是利用人类微生物组的力量解决重大未满足医疗需求的重大突破。这是FDA首次批准活生物治疗药物，也是数十年研究和临床开发的结晶，”Ferring总裁Per Falk说。重要的一步有望利用我们对微生物组在人类健康和疾病中的作用的快速发展的见解，更好地理解、诊断、预防和治疗许多其他疾病。” Ferring Pharmaceuticals美国总裁Brent Ragans表示：“Rebyota是一种急需的新疗法，它为每年遭受复发性艰难梭菌感染的数千人带来了希望，Rebyota不仅有可能影响患者和护理人员，还有医疗保健系统。”Ferring Pharmaceuticals是一家以研究为导向的专业生物制药集团，是生殖医学和女性健康以及胃肠病学和泌尿学专业领域的领导者。50多年来，Ferring一直致力于为母亲和婴儿开发治疗方法，其产品组合涵盖从受孕到分娩的整个治疗过程。微生物制药商业化进程从2007年美国启动人类微生物组计划开始，微生态制药的发展进入了加速阶段，一大批领先的微生物制药明星企业开始崭露头角：Nexbiome、Evelo、Mikrobiomik、Seres、Rebiotix等公司，辉瑞、罗氏、辉凌等跨国制药巨头也开始布局微生态制药赛道。Seres therapeutics，美国临床生物制药公司，以微生物组学疗法治疗全球患者。研发药物治疗由微生物生态失调引发的各种疾病。Seres therapeutics探明健康和生态失调微生物组学间的差异，设计由益生菌组成的生态混合药Ecobiotic，靶向治疗功能缺陷的微生物组，并重建健康微生物生态。Seres therapeutic主打药物SER-109，可治疗艰难梭菌感染引起的肠道疾病，公司还研发治疗2型糖尿病等代谢疾病的药物。中国，同样涌现了不少企业，未知君生物、慕恩生物、知易生物、厌氧生物等皆有在研管线。未知君在2021年就获得FDA临床试验批准，未知君FMT药物拿到美国FDA的IND批件，意味着公司正式迈入临床研发阶段，未来公司将重点与国内多家知名医疗机构开展临床研究合作，发力肿瘤治疗、神经系统和免疫系统三大领域。据不完全统计，全球微生态制药公司已经超过50家，其中有30余家累计吸金超过30亿美元。撰文|乔维钧排版|木子久End参考资料：[1]https://designershitdocumentary.com/how-to-become-a-fecal-transplant-donor/[2]https://new.qq.com/omn/20191022/20191022A0NY6K00.html[3]https://www.sohu.com/a/481319363_178984[4]https://new.qq.com/omn/20191022/20191022A0NY6K00.html[5]https://36kr.com/p/dp2026324036889603 本文系生物探索原创，欢迎个人转发分享。其他任何媒体、网站如需转载，须在正文前注明来源生物探索。   往期精选 围观全球首例！人造血成功输入体内，尚无不良反应，实现血型定制！ 热文全世界精子数量加速下降，男人们到底怎么了？ 热文 低蛋白饮食让癌细胞「挨饿」而亡！这样吃能有效增强癌症治疗效果 热文“爱憎分明”的抗癌药物，只对癌细胞出手，在健康组织中失活！ 热文 点击“阅读原文”，了解更多~

GERMANTOWN, Md., Oct. 5, 2021 /PRNewswire/ -- In early 2020 when the US Food and Drug Administration (FDA) issued a series of safety alerts on the risk of transmitting SARS-CoV-2 via fecal microbiota transplantation (FMT), the Cambridge-based stool bank OpenBiome was left with freezers full of processed donor stool samples that could not be released until tested for the new virus. Now, thanks to a testing solution provided by the microbiome laboratory services company CosmosID, the stool bank is able to quickly screen and distribute the stored treatments to patients across the US who suffer from recurrent C. difficile infection. The custom CosmosID test, which OpenBiome implemented after review by the FDA, detects SARS-CoV-2 genetic material in donor stool using reverse transcription polymerase chain reaction (RT-PCR)—the same molecular technique used in COVID-19 diagnostic testing. OpenBiome will now test its large inventory of FMT treatments manufactured after December, 2019, which had largely been previously ineligible for distribution per the FDA safety alerts. The test allows OpenBiome to restore its supply chain of FMT treatments and once again make them widely available to patients. Carolyn Edelstein, Executive Director of OpenBiome, says, "CosmosID brought a solutions-oriented mindset to the challenge — they were creative, pragmatic, and proactive, and were utterly committed to the goal of making sure that patients would maintain safe access to fecal transplantation. It has been terrific to collaborate with them on this solution for patients and public health." Manoj Dadlani, CEO of CosmosID, says in order to successfully develop the test, the company leveraged its scientific team's particular expertise in molecular techniques for analyzing stool samples. The team also flexibly adapted to the changing regulatory requirements during the validation process. Dadlani says, "Our team has extensive experience using next-generation sequencing technologies to analyze gut microbiomes for many different applications – including detecting the presence of disease-causing microbes. We welcomed this collaboration with OpenBiome to come up with a quick and easy test for their banked stool samples, which helps them continue their work." Majdi Osman, Chief Medical Officer at OpenBiome, emphasizes the test's importance to patients. "Rigorous donor screening is critical to enhancing safety and enabling access to FMT for patients with C. difficile who have exhausted all treatment options. Until now, the challenges of directly testing for SARS-CoV-2 in stool have significantly limited physicians' abilities to treat patients with C. difficile infection," he says. "Screening our inventory using the stool-based assay developed by CosmosID will allow thousands of patients to get much-needed treatment for C. difficile infection. For these patients, an FMT is a chance to recover from a debilitating infection and return to a normal life." To find out more, visit the CosmosID website: About CosmosID CosmosID®, based in Germantown, Maryland, is a genomics big data company focused on rapid identification of microorganisms for molecular diagnostics, clinical trials, public health, food safety, agriculture, and environmental applications. The CosmosID platform uses proprietary sequence analysis algorithms to accurately pro microorganisms in a metagenomic sample employing next-generation DNA sequencing. CosmosID was founded in 2008 by Dr. Rita Colwell, former director of the National Science Foundation and currently Distinguished University Professor at the University of Maryland and Johns Hopkins University Bloomberg School of Public Health. To learn more please visit . Media Contact: Vickie Lord 320397@email4pr.com 703-995-9879