Cloudbreak Therapeutics LLC

「  本文共：17条资讯，阅读时长约：3分钟 」今日头条爱科诺RIPK2抑制剂获批I期临床。爱科诺生物自主研发并拥有全球权益的RIPK2抑制剂AC-101获澳大利亚人类临床研究伦理委员会（HREC）批准，即将启动I期临床试验。临床前研究显示，AC-101能有效抑制NOD-RIPK2通路依赖的炎症因子的释放，在炎症性肠病（IBD）模型中具有积极的保护效果。该新药拟开发用于炎症性肠病的治疗。‍‍国‍‍‍‍‍‍‍内‍‍药讯‍‍‍1.药欣口服难溶性药物获批白血病临床。深圳药欣生物基于其新一代无定形固体分散体技术SpraySol™平台开发的小分子药物HLK-1004获FDA临床许可，拟开展用于治疗新诊断的或对既往治疗耐药或不耐受的费城染色体阳性的慢性髓性白血病（Ph+CML)慢性期或加速期成人患者，以及2岁以上儿童慢性髓性白血病的临床研究。该公司还计划尽快启动HLK-1004的国内IND申报工作。2.FIC多激酶抑制剂在华获批眼科临床。Cloudbreak公司1类化药CBT-001眼用乳液获国家药监局临床试验默示许可，拟开发用于阻止翼状胬肉生长及减少结膜充血。CBT-001是一种强效多激酶抑制剂，其靶向VEGFRs、PDGFRs、FGFRs等靶点，可以抑制血管生成和纤维化。在Ⅱ期临床中，CBT-001在减少翼状胬肉血管分布、角膜病变长度和结膜充血方面表现出较为显著的疗效，而且药物总体耐受性良好，且没有报告严重的药物反应或不良反应。3.祐和全球首创PD1/CD40双抗国内获批临床。百奥赛图旗下祐和医药1类生物制品YH008注射用冻干粉获国家药监局临床许可，拟开展评估用于晚期肿瘤受试者治疗的I期临床。YH008具有PD-1依赖的CD40激动活性，同时又具有两个靶点的免疫协同作用。去年12月，YH008已获FDA批准开展I期临床，评估单药治疗PD-(L)1耐药的晚期实体瘤和血液瘤患者的安全性和初步疗效。4.博奥信Siglec-15单抗国内报IND。博奥信生物1类新药BSI-060T注射液的临床试验申请获CDE受理。BSI-060T是博奥信开发的抗Siglec-15单克隆抗体，可通过靶向M2巨噬细胞、S15诱导的骨髓细胞和S15阳性肿瘤，来阻断S15引起的免疫抑制。2022年12月，BSI-060T已获FDA批准临床，用于治疗膀胱癌、胆管癌、结直肠癌和肾癌等实体瘤患者。Pyxis Oncology公司拥有BSI-060T在大中华区以外的全球开发和商业化授权。5.凡恩世与安斯泰来子公司达成合作。凡恩世公司宣布与安斯泰来公司旗下的Xyphos Biosciences公司达成一项研究合作协议，将利用凡恩世公司的专有技术平台PACbodyTM和SPECpairTM评估肿瘤领域中的细胞疗法。PACbodyTM和SPECpairTM技术平台可以构建天然IgG结构的双特异性抗体，并能利用传统的单克隆抗体制备工艺来生产。根据协议，凡恩世将获得技术使用费和进一步的合作研究支持。财务条款细节未披露。6.上海柏全生物完成逾亿元PreA轮融资。上海柏全生物宣布完成逾亿元PreA轮融资，本轮融资由凯风创投领投，宏科百世与仙瞳资本跟投，天使轮投资方上海生物医药基金追加投资。柏全生物成立于2020年，致力于肿瘤免疫治疗新靶点和药物研发与生产。该公司的主要管线针对PD-1/PD-L1抑制剂治疗无效的肿瘤为主要适应症，已完成IND相关的主要研究。本轮融资将用于推进首款产品的临床前与临床研究。‍‍‍‍国‍‍‍‍‍‍‍‍‍‍际‍‍‍‍药‍讯‍‍1.默沙东PCSK9抑制剂IIb期临床成功。默沙东PCSK9抑制剂MK-0616治疗高胆固醇血症患者的IIb期临床MK-0616-008（NCT05261126）结果积极。与安慰剂相比，MK-0616治疗在第8周时能显著降低患者的低密度脂蛋白胆固醇（LDL-C）；经安慰剂调整后，4个剂量组（6mg、12mg、18mg和30mg）的LDL-C水平较基线分别下降41.2%、55.7%、59.1%和60.9%，均具有统计学显著性。MK-0616的耐受性良好，未出现与治疗相关的严重不良反应。2.卫材Aβ抗体获FDA优先审评。卫材与渤健合作开发的阿尔茨海默病抗体疗法Leqembi（lecanemab）的补充生物制品许可申请（sBLA）获FDA受理，寻求将加速批准转变为完全批准。FDA同时授予其优先审评资格，预计今年7月6日前做出回复。在Ⅲ期临床中，与安慰剂组相比，Leqembi治疗组患者第18个月时评估患者认知和日常功能的综合评分CDR-SB的增加速度降低27%，淀粉样蛋白沉积水平降低约70%。3.FGFR3抑制剂治疗软骨发育不全Ⅱ期临床积极。BridgeBio公司口服FGFR3抑制剂infigratinib治疗软骨发育不全儿童患者的Ⅱ期临床结果积极。infigratinib通过阻断FGFR3的活性直接靶向软骨发育不全的潜在病理生理学，从而促进软骨内骨形成，让患儿的生长速率恢复正常。结果显示，接受最高剂量治疗的患儿在6个月时，年平均身高生长速度较基线提高3.03厘米/年（p=0.0022），药物总体耐受性良好。4.阿斯利康/第一三共ADC实体瘤Ⅱ期临床积极。阿斯利康与第一三共开发的HER2-ADC新药Enhertu（trastuzumab deruxtecan）在治疗HER2阳性、转移性实体瘤经治患者的Ⅱ期临床（DESTINY-PanTumor02）最新结果积极。入组患者癌症种类包含胆道癌、膀胱癌、宫颈癌、子宫内膜癌、卵巢癌、胰腺癌和罕见肿瘤。分析显示，Enhertu达成客观缓解率和缓解持续时间这两项疗效终点。研究中，药物的安全性与以往试验一致。5.Theravance暂停吸入型JAK抑制剂开发。Theravance公司在2022年财务报告中透露，公司将优先分配资源给去甲肾上腺素再摄取抑制剂ampreloxetine的III期CYPRESS研究以及完成M3受体拮抗剂Yupelri（revefenacin）与噻托溴铵相比治疗重度慢性阻塞性肺疾病（COPD）的IV期PIFR-2研究，暂停吸入型JAK抑制剂TD-0903开发计划。TD-0903拟开发用于治疗急、慢性肺部炎症、纤维化疾病，目前处于II期阶段。受此影响，Theravance 的员工总数将减少约17%，裁员计划将于2023年3月底前完成。6.Incyte终止帕萨利司一项联合用药III期研究。Incyte公司宣布将终止PI3Kδ抑制剂帕萨利司（Parsaclisib）联合芦可替尼治疗骨髓纤维化的III期LIMBER-304研究。该项试验在对芦可替尼反应不佳的骨髓纤维化患者中评价Parsaclisib联合芦可替尼治疗的效果。独立数据监测委员会（IDMC）评估的中期分析表明，该研究不太可能达到意向治疗患者群体的主要终点。信达生物拥有parsaclisib在大中华区的开发和商业化权利。‍‍‍‍‍‍‍‍医‍‍‍‍‍药‍‍‍‍‍‍‍‍热‍‍‍‍‍点‍‍‍‍‍‍‍‍1.财政斥2000亿元支持地方防疫等工作。3月5日，十四届全国人大一次会议审查《关于2022年中央和地方预算执行情况与2023年中央和地方预算草案的报告》。《报告》对2023年主要收支政策作出安排，明确支持提高医疗卫生服务能力。《报告》提出，通过一般性转移支付安排财力补助资金1700亿元、使用2022年权责发生制结转资金300亿元，支持地方做好疫情防控等工作，重点向县级财政倾斜。2.海南省医改研究智库成立。日前，海南省医改研究智库在海口市成立，37名省内外专家被聘为首批海南省医改研究智库特约研究员。海南省医改研究智库将对海南省医改进行整体性、系统性、专业性的研究，为海南各级卫生健康行政部门、企事业单位及社会各界提供医改政策咨询和服务，以前瞻性的医改研究成果和专业的服务，深化海南医疗、医保、医药联动改革，持续推进解决人民群众看病难、看病贵等问题。3.强生中国骨科负责人离任。强生中国日前宣布，强生医疗科技中国骨科负责人陈敏将于3月12日正式离任，现任强生脊柱及PCMFT事业部副总裁韩伟将担任强生中国骨科事业部总经理，于2023年3月1日生效。资料显示，韩伟由校招加入强生医疗，从一线销售开始，先后担任Cordis Endovascular和ASP事业部总监，并于2016至2018年在美国参加全球发展计划(IDP)，担任BW全球战略市场部总监。4.英国重启“热线聊天”志愿项目。英国《每日邮报》5日报道称，英国正在重启疫情期间的“热线聊天”志愿项目，医生将为需要被倾听或聊天的患者“转接热线电话”。目前，该项目已有超过1000名志愿者报名参加。研究显示，孤独会对健康造成负面影响，相当于肥胖或每天吸15支烟，此外，孤独还会增加认知能力衰退的风险。‍‍‍‍‍‍‍评‍‍‍‍‍审‍‍‍‍动‍‍态‍‍‍‍‍‍‍  1. CDE新药受理情况（03月07日)   2. FDA新药获批情况（北美03月04日）股市资讯上个交易日 A 股医药板块 -1.61%涨幅前三     跌幅前三*ST 辅仁 +4.72%  振东制药 -7.31%诚意药业 +3.78%  贵州三力 -7.05%德源药业 +3.26%  欧林生物 -6.55%【上海医药】(1)硫酸镁注射液获得批准生产;(2)将与康方药业以联合用药的合作方式共同进行 SPH4336片与开坦尼组合疗法在高分化脂肪肉瘤(WDLS)/去分化脂肪肉瘤(DDLS)等肿瘤适应症上的开发，推进组合产品的研发、生产。【中国医药】注射用特利加压素获得药品注册批件。【赛诺医疗】远端通路导管获得医疗器械注册证书。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

Artificial intelligence leads the top tweeted terms are the trending industry discussions happening on Twitter by key individuals (influencers) as tracked by the platform. 1. Artificial intelligence – 802 mentions The steps being taken to integrate artificial intelligence (AI) into healthcare and the use of AI techniques in the detection and management of various diseases were popularly discussed in Q2. Rafael Grossmann, a surgeon and clinical innovator, shared an article on two new companies namely Anumana and Lucem Health being launched by healthcare company Mayo Clinic that will collect and analyse patient data gathered from remote monitoring devices and tools to enable early detection and diagnosis of diseases. Mayo Clinic will launch a remote monitoring platform that will enable clinicians and physicians to make quicker and better decisions with the help of the collected and analysed patient data thereby speeding up the diagnosis before symptoms appear. It will also allow patients to take more control of their health and related decisions. AI was also discussed with reference to how the technology is helping in the treatment and management of diseases such as Parkinson’s. Engineers from Imperial College and a start-up have enrolled a patient with Parkinson’s into a trial that uses a wearable device developed using AI techniques to monitor and manage the disease, according to an article shared by Berci Meskó, director of The Medical Futurist Institute. The trial aims to collect data on all the symptoms of the disease as well as data on how a patient responds to medication. The term was also mentioned in an article shared by Gary Monk, a healthcare technologist, on biotechnology firm Viome receiving breakthrough device designation from the US Food and Drug Administration (FDA) for its mRNA analysis technology tool and AI platform. The technology analyses the interactions between microbial activities and human gene expression in saliva samples to detect and predict the progression of oral and throat cancers. Important steps to integrate #AI into #Healthcare Mayo Clinic launches 2 new companies to use patient data and AI to advance early Diagnosis! #DigitalHealth with meaningful #Digitaltransformation — Rafael Grossmann,MD, FACS 🇻🇪🇺🇸 (@ZGJR) April 15, 2021 2. Telehealth and telemedicine – 885 mentions Physicians being in favour of permanent telehealth expansion, telehealth services reporting high patient satisfaction during the pandemic, and extending telemedicine to the homeless community were popularly discussed in the quarter. A recent study conducted by a team of researchers from Syracuse University has found that physicians are in favour of telehealth services being made permanent, according to an article shared by Vince Kuraitis, founder of Better Health Technologies, an independent healthcare consulting company. Many medical health professionals, however, opine that the challenges related to virtual care technologies should not be ignored. Telehealth services, in some cases, limited physicians’ ability to provide healthcare, while organisational support for these services was also lacking. Health economists argue that although telehealth services increase healthcare access to many people, especially in remote settings, a higher market concentration can adversely reduce access. Discussions around telehealth also included an article shared by Harry Greenspun, a physician and partner at management consulting firm Guidehouse, on telehealth services registering high patient satisfaction rates during the pandemic, according to a survey conducted by Covid-19 Healthcare Coalition. The survey found that more than 70% of the patients preferred to access virtual care even after Covid-19. It also found that 83% of the respondents considered telehealth services to be effective, while 78% believed their health concerns were proactively addressed. Experts, however, believe that more training is required to ensure telehealth access to patients aged 65 years and older who face difficulties in using telehealth services. Telemedicine was also discussed with reference to how the technology can be expanded to the vulnerable sections of the society such as the poor and the homeless, according to an article shared by Jamey Edwards, the CEO of Cloudbreak Health, a unified telemedicine company. A number of service providers and local officials implemented telemedicine services to prevent a surge in infections among the poorer communities. A collaboration in 2020, for example, allowed homeless veterans to consult through telehealth kiosks. The headline: "Physicians in favor of permanent telehealth expansion" The fine print: "physicians who practice internal medicine are in favor: more than 40% say they would continue with telehealth".#TelemedNow — Vince Kuraitis (@VinceKuraitis) May 28, 2021 3. Covid-19 – 484 mentions Various Covid-19 detector tools being developed by companies were popularly discussed in the second quarter of 2021. Multi-national conglomerate GE is working on a Covid-19 detector that is being integrated into an iPhone, according to an article shared by John Nosta, founder of NostaLab, a healthcare think tank. The sensors can be fitted into devices such as smartwatches and phones to identify airborne viruses and bacteria on surfaces or in a person’s breath, the article noted. The GE microchips are expected to be upgraded in time to detect a seasonal flu and other pathogens. The company along with the National Institute of Health (NIH) has been awarded a grant to develop a prototype sensor chip that can initially detect one virus and later be customised to detect multiple viruses. Covid-19 was also discussed in the context of technology company Apple launching a new smartwatch study to identify the disease especially in at-risk groups, according to an article shared by Daniel Kraft, a Stanford and Harvard trained physician-scientist. The Apple respiratory study will analyse optical heart sensor of wearable devices and conduct weekly surveys to determine patterns among iPhone participants who are infected with the SARS-CoV-2 virus, flu, or other infections. The study is being conducted by researchers from the University of Washington School of Medicine, Apple, the Seattle Flu Study, and the Brotman Baty Institute for Precision Medicine. It will assess disease patterns in individuals aged 22 years and older who are at a higher risk of contracting infections due to their frontline jobs and other close group activities. Researchers will also focus their study on indigenous, Black, and Latin communities who have been disproportionately affected by the pandemic in the US. GE is developing a COVID-19 detector that fits in an iPhone #COVID19 #digitalhealth — John Nosta (@JohnNosta) April 10, 2021 4. Innovation – 475 mentions Collaborations and partnerships formed in healthcare research and innovation, and exponential developments in healthcare technology were popularly discussed in Q2. Five industry associations specialising in areas such as biotech, pharmaceutical, and medical technologies in Europe have collaborated with the European Commission (EC) on a strategic agenda for research and innovation in healthcare over the next ten years, according to an article shared by Sherry Reynolds, an eHealth strategy expert. The collaboration, named Innovative Health Initiative (IHI) framework, is part of the $132.35bn Horizon Europe funding programme that seeks to strengthen healthcare systems. It will create a robust research, development and innovation ecosystem that promotes cost-effective public-private innovations as well as cross-sectoral innovations in the region, the article highlighted. Innovation was also discussed in an article shared by Donna K Lencki, a health tech entrepreneur, on Cleveland Clinic’s plans to expand its commercialisation arm by adding a new digital health partner who will oversee innovations as well as develop a pipeline of health information technology (IT) start-ups. The new partner will help start-ups raise funds for commercialisation of technology and provide assistance in project development and management. Five industry groups – pharma, biotech and med tech + European Commission (EC) are working on a Strategic Agenda for Research & #Innovation in #Healthcare as part of €95.5 billion Horizon Europe The IHI framework will cover the entire care continuum. — Sherry Reynolds 🌟 (@Cascadia) June 25, 2021 5. Machine learning – 264 mentions A machine learning (ML) model that helps in predicting whether Covid-19 patients need dialysis, the US Food and Drug Administration (FDA) authorising an ML software to help in diagnosing autism, and the use of ML use in detecting natural product drugs, were popularly discussed in the second quarter. A team of researchers used data from hospitalised Covid-19 patients from the Mount Sinai Health System and deployed an ML model to help predict whether a patient requires dialysis or is at a high risk of death, according to an article shared by Ken Congdon, director of content marketing at Prognos Health, a clinical data and analytics platform. Five ML models namely LASSO, XGBoost with imputation, random forest, XGBoost without imputation, and logistic regression were evaluated as part of the study. The team found that the XGBoost with imputation ML model was the most effective in predicting dialysis or death in patients. Researchers claim that ML models can help in identifying complex patterns in large amounts of data. They can also help in Covid-19 disease prognosis by identifying the associated complications and underlying factors that can worsen or improve the condition of a patient. Other discussions around ML involved Gary Monk’s tweet on the US FDA granting marketing authorisation to an ML software that helps diagnose autism. The ML system was developed by digital health start-up Cognoa and utilises information from home videos and questions from parents and clinicians to help paediatricians in diagnosing autism. The goal of the model is to detect autism spectrum disorder (ASD) in the early stages as data reveals that kids in the US develop autism as early as four years but many are not able to meet a specialist in time. The FDA authorisation comes after a double-blind study that was conducted on 425 kids ranging in age from 18 months to five years in 14 different locations. Cognoa also ensured that the participants were from different ethnic groups and gender. Berci Meskó shared on article on a new process using ML algorithms developed by Carnegie Mellon University researchers that can detect natural product drugs, which can be used to treat various ailments including cancers and viral infections. Penicillin is one of the popular drugs derived from natural products and was discovered by chance. Replicating the drug for potential human use and efficacy, however, is a difficult task for laboratories. ML algorithms can assist researchers in detecting and isolating natural products that can be used to develop natural product drugs for humans, the article highlighted.