Univo Pharmaceuticals Ltd.

RALEIGH, N.C.--( BUSINESS WIRE )--Today, Univo IRB was announced as the new company name for Principal IRB. Univo IRB is a next generation institutional review board (IRB) recently acquired by QHP Capital, an investment manager exclusively focused on building and supporting tech-enabled life sciences and pharma services companies. Univo IRB is focused on full-scale IRB services, bringing decades of IRB and clinical operations experience to support today’s clinical trials. At last week’s SCOPE Summit in Orlando, Florida, Univo IRB shared its plans to bring the voice of patients closer to research by creating an agile and efficient IRB review experience. This experience can only be achieved by combining Univo’s highly proficient workforce consisting of IRB members and staff who have hands-on research experience and industry-first technologies that are purpose-built for today’s complex trials. Univo IRB maintains accreditation through the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which consists of a federally regulated IRB committee charged with protecting the rights and welfare of people in research. “The IRB sector has seen significant consolidation as firms vie to remain competitive in the face of economic, regulatory, and societal challenges affecting research review and oversight; however, most IRB’s have become too big and bureaucratic, limiting their agility and ability to service customers and patients in today’s modern research environment,” said Univo IRB President Julie Blasingim . “At Univo, we do not want to be biggest IRB, but we are clearly focused on being the best! We welcome you to experience the best and witness our commitment to highly qualified IRB reviews with fast turnarounds and exceptional customer experience.” “Univo IRB is committed to reviving the IRB industry’s focus on principles of human research protection, unifying patients and research,” said Michael Sorensen , Partner at QHP Capital. “We remain committed to supporting this team of IRB experts and the company as it launches the modern iteration of IRB solutions and grows to support the next generation of clinical trials.” About Univo IRB Univo IRB , formerly Principal IRB, is a next generation institutional review board (IRB) specializing in the ethical review of Phase I-IV pharmaceutical, device, biologic, behavioral, and psycho-social research. We offer agile study approaches, expert solutions powered by industry-leading study technology, and a service-first approach. Univo IRB holds accreditation through the Association for the Accreditation of Human Research Protection Programs (AAHRPP). With support from senior advisors and 60+ years of industry experience, Univo IRB guides your study to approval while respecting the rights and welfare of patients every step of the way. About QHP Capital QHP Capital, L.P. invests in lower middle market healthcare companies primarily in North America, with a focus on services and technology companies where a strategic partner and operating resources can accelerate growth. Targeting companies in healthcare and pharmaceutical services industries, QHP invests in the form of buyouts, growth equity, and recapitalizations.

▎药明康德内容团队编辑就在昨天，微生物组疗法又迎来了一项重大里程碑，美国FDA批准Seres Therapeutics公司口服微生物组疗法Vowst（SER-109）上市，用于预防成人患者艰难梭菌感染（CDI）复发。SER-109旨在帮助患者恢复胃肠道内微生物的多样性。艰难梭菌是一种抗生素耐药菌，可导致腹痛、腹泻以及结肠损伤，已被美国疾病控制和预防中心（CDC）列为紧迫威胁之一。截至目前，美国FDA仅批准的两款微生物组疗法Rebyota（于去年11月获批）和Vowst均用于预防CDI复发，且不含抗生素，这缓解了日益严峻的微生物耐药问题。01什么是微生物组疗法栖息在人体内的微生物和健康息息相关。胃肠道拥有非常复杂的微生物群落，它们各司其职，帮助宿主合成必备的营养元素，参与代谢和神经信号调节，激活免疫应答，是人体健康的“晴雨表”。一旦微生物组失衡，疾病可能悄然而至。研究表明，紊乱的肠道菌群与肥胖、2型糖尿病、非酒精性脂肪肝病（NAFLD）等多种代谢疾病的发病机制有关，还有可能是炎症性肠病（IBD）进展的关键因素。IBD患者体内的肠道菌群的构成发生变化，表现在如大肠杆菌等兼性厌氧菌的增加和专性厌氧菌的减少，同时微生物组的多样性也发生锐减。此外，微生物组还会通过肠-脑轴影响机体的大脑结构，造成中枢神经系统疾病的发生......图片来源：123RF微生物世界隐藏着太多未解之谜，既然菌群失衡是导致疾病的“罪魁祸首”，那么利用“好”的微生物调节菌群也不失为疾病治疗方案的一种选择。02微生物组药物临床管线先后获美国FDA批准上市的两款药物拉开了微生物组疗法从临床迈入商业化应用的序幕，其安全性和有效性得到了证实。近几年，越来越多的新锐公司和科研机构加入，希望挖掘寄生在人体的微生物组和疾病之间的关联，研发新药，提供新的治疗方案。测序技术的进步及器官芯片的应用加快了微生物组疗法的研发进程，但如何确定与疾病相关的细菌种类仍然是个问题。根据多渠道信息汇总整理和统计，目前56%的微生物组疗法处在临床前阶段。和5年前相比有了明显的进步，约32%的药物已经进入临床试验，另有3%的药物成功上市。从疾病类型来看，胃肠道疾病是现在药物研发分布最多的治疗领域。随着微生物组和疾病机制之间的关联不断被揭开，微生物组也被视为治疗癌症、细菌感染、2型糖尿病等代谢疾病的方法。7款药物已经在美国、澳大利亚等地上市，多针对CDI感染和消化系统疾病。胃肠道疾病：多针对IBD和IBS目前共有35种微生物组疗法已经迈入临床试验阶段，多数疗法针对炎症性肠病（IBD）和肠易激综合征（IBS）。克罗恩病是IBD的一种亚型，会使患者消化道出现炎症 。4D pharma研发的Thetanix可治疗儿童克罗恩病，这是一种单菌株人类肠道共生细菌，具有抗炎机制，可以改善肠道粘膜屏障功能，从而减少突破粘膜屏障的病原体，目前已经完成1b期临床试验。针对IBS，该公司研发了Blautix，可降低肠道中的二氧化碳和氢气水平，相应地减少了IBS患者肠道内的气体，减轻腹胀和腹痛的频率。另有3款药物进展较快，目前已经进入3期临床试验阶段。其中，瑞典公司Infant Bacterial Therapeutics研发的一款预防早产儿坏死性小肠结肠炎的活细菌疗法IBP-9414，含有活性化合物罗伊氏乳杆菌，这是一种天然存在于母乳中的有益菌，可以改善早产儿脆弱的肠道功能。平衡微生物组，对抗细菌感染抗感染也是微生物组疗法重点关注的领域之一。传统抗生素无差别杀死体内“好坏”各种细菌，利用微生物对抗致病细菌可以避免扰乱体内微生物组，阻止“坏”的抗耐药性细菌在体内定居，加重疾病。目前有近20款针对细菌感染的微生物药物进入临床试验阶段，多数药物用于治疗CDI，此外大肠杆菌感染和尿路感染（UTI）也是较受关注的疾病类型。抗癌新兴领域：和检查点抑制剂联用增强免疫应答近年来，微生物组疗法抗癌已经成为了一个热门趋势。发表在《科学》杂志的多项研究表明，微生物组疗法和检查点抑制剂联用，有望增强肿瘤对免疫疗法的应答。研究催生了许多公司和大型药企的合作，希望通过药物联用，增加对检查点抑制剂产生应答的患者数量。4D pharma研发的MRx0518疗法是一种口服的鸡肠球菌菌株，与默沙东（MSD）抗PD-1疗法Keytruda联用，在治疗肾细胞癌的1/2期临床试验中达到主要疗效终点，在试验队列扩展阶段还将适应症扩展至其他多个实体瘤。此外，4D pharma还与辉瑞和德国默克（Merck KGaA）合作开展临床试验，与Bavencio联用治疗局部晚期或转移性尿路上皮癌患者。03跨国药企纷纷布局跨国药企在该领域又有什么动作？其实近5年来，微生物组疗法的潜力得到了诸如罗氏、武田、辉瑞等跨国药企的关注，它们携手微生物组疗法公司，共同推进创新药物研发。罗氏（Roche）旗下的基因泰克（Genentech）与Novome Biotechnologies达成一项多年研究合作和授权协议，将利用Novome专有的基因工程微生物药物（GEMMs）平台来发现、改造和开发细菌菌株，用于治疗IBD等疾病。Novome通过对食品中常见的乳酸乳球菌进行工程设计，开发了GEMMs技术平台。这些工程化细菌可在人体肠道中可控和强效定植，从而递送靶向治疗药物。根据协议，Novome从基因泰克获得1500万美元的预付款，与未来达5.9亿美元的潜在开发和商业里程碑付款，以及产品日后净销售的分级特许权使用费。葛兰素史克（GSK）与Eligo Bioscience达成合作协议，共同推进一种基于CRISPR的痤疮疗法。Eligo设计了一种噬菌体衍生的颗粒携带DNA切割CRISPR系统，只在有害的特定细菌的基因组中进行DNA双链切割从而将其杀灭，而有益细菌则完好无损。根据协议，Eligo将有资格获得最高不超过2.24亿美元的许可费和潜在里程碑付款。吉利德科学（Gilead Sciences）与Second Genome达成为期四年的战略合作，以开发新的生物标志物，共同确定与吉利德科学研发管线中5种在研疗法的临床应答相关的生物标志物，并开发治疗炎症性肠病（IBD）的潜在新靶点和候选药物。Second专有的微生物组发现平台能够利用微生物组学的最新见解帮助细分患者，并优化适合患者的潜在疗法。根据协议，Second获得3800万美元的前期付款，和约3亿美元的潜在里程碑付款，以及就所开发药物的销售额分成。写在最后此次口服粪便微生物疗法获FDA批准的好消息是一剂强心针，证明了微生物组疗法研发领域的价值与潜力。正如知名风投机构Flagship Pioneering的创始人兼首席执行官Noubar Afeyan博士在公开信中所述，先驱性的科学研究需要不断失败和长期经验的积累，才能一飞冲天，完成突破。读者们请星标⭐创鉴汇，第一时间收到推送免责声明：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。版权说明：本文由药明康德内容团队根据公开资料整理编辑，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发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。参考资料[1] Yong Fan & Oluf Pedersen. Gut microbiota in human metabolic health and disease. Nature Reviews Microbiology,2020. doi: https://doi.org/10.1038/s41579-020-0433-9[2] FDA批准首个粪便微生物产品，这个领域能否成为新药开发的下一个宝藏？Retrieved Dec. 3 from https://mp.weixin.qq.com/s?__biz=MzUxMTY5MzM5OQ==&mid=2247535386&idx=1&sn=c52dae6f5dbeeae1e0d5218b9b6fa702&chksm=f96dcc22ce1a45342ac2088f71bb8ba664154ae86b0f4678cc832cf06867b26dc6800b5f345e#rd[3] Microbiome Modulator Drugs – The New Generation of Therapeutic. Retrieved Feb. 3 from https://pharmaintelligence.informa.com/resources/product-content/microbiome-modulator-drugs[4] 各大公司官网更多数据内容推荐  点击“在看”，分享创鉴汇健康新动态

BIOMODEX® is a Boston and Paris-based medical technology company whose mission is to transform the way physicians train and rehearse procedures BIOMODEX Launches Synthetic Clot Product. (Credit: Arek Socha from Pixabay.) BIOMODEX®, the leader in biorealistic haptic simulators for physician training and rehearsals, has announced the launch of Thrombotech™, a new hydrogel-based synthetic clot product that can be used for neurovascular training using EVIAS Plus™ – Biomodex’s innovative training solution for the treatment of ischemic stroke. Thrombotech mimics the density and texture of an actual human blood clot. It can be inserted into a Biomodex 3D printed blood vessel cartridge that plugs into the EVIAS Plus station. Physicians can then practice retrieving the clot using aspiration and mechanical thrombectomy techniques. A Distal Clot Filter allows physicians to see if they effectively retrieved the clot. This technology stands to benefit medical device companies that are developing new devices for thrombectomies and for fellows who are training for these complex emergency procedures. “Medtech companies and physicians are excited by Thrombotech because of its realistic nature,” said Ziad Rouag, President and CEO of Biomodex. “Clients using our biorealistc haptic simulators were telling stories about buying children’s slime or using chicken livers to simulate clots, none of which were realistic for training and rehearsals. So we set out to develop our own solution.” Thrombotech is available in three densities: Soft, Medium, and Hard. Soft mimics Red Blood Cell (RBC) rich clots, Medium mimics an RBC/Fibrin clot, and Hard mimics a Fibrin-rich clot. The solution is also fully customizable; the density can be adjusted, or ingredients can be added to mimic calcium buildup. “The realism of Thrombotech is unmatched by anything on the market today. Having a clot solution that accurately represents the density and texture of a human clot will better serve those training for complex thrombectomy procedures. This could help speed the advancement of new medical devices and training on those devices, bringing cutting edge treatments to patients faster,” said Keith Lauver, Chief Marketing Officer of Biomodex. Source: Company Press Release