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【资本】HealthcareWeekly(海外版)(2017.03.20)
来源: www.qd-zyz.com  发布日期: 2019-11-30

  导语:

  研究异种器官移植的eGenesis获投3800万美元,“你是猪吗”或不再是调侃

  智能医疗新趋势!Livongo Health再获5250万美元D轮融资

  腰椎减减压,融资轻松拿,Vertiflex 获4000万美元风险投资

  Threshold Pharmaceuticals与Molecular Templates达成合并协议

  杯具阿斯利康重磅新药再被拒

  AveXis公司继续推进SMA基因疗法I期临床试验数据积极

  美国医药界猛烈抨击川普第一预算案

  私募融资

  1.CRISPRA改造猪的器官给人移植,生物技术企业eGenesis获3800万美元A轮融资

  概要:致力于解决器官短缺难题的生物技术初创企业eGenesis A轮融资3800万美元,领投方Biomatics Capital和ARCH Venture Partners。该公司由来自哈佛大学医学院的团队创立,利用本轮融资,公司将借助CRISPR基因编辑技术降低异种器官(猪)之间的排异反应和异种病毒的危害,打造出一套安全有效进行异种移植的临床方案,推动异种器官移植应用造福有需要的患者。

  

  相关报道:

  eGenesis gains $38M to use CRISPR to help tame pig organs fortransplants

  Mar 16, 2017

  Upstart eGenesis got off a healthy $38 million Series A round today as it looks to use cutting-edge science to “solve the shortage of organs for donation” by using pigs and CRISPR.

  The funding, led by Biomatics Capital and ARCH Venture Partners,will help the Cambridge, Massachusetts-based biotech to develop its genome-editing tech to make xenotransplantation (using organs from otheranimals for human use) “a routine and lifesaving medical procedure.” Using organs from other animals for human transplantation has proven highly complex: The biotech’s exec teams tells me that the best animals to use are pigs, given that they are of a similar size and physiology tohumans, but key risks include immunological incompatibility and viral transmission (PERV), “which is why we have focused on these areas in our early research.”

  Back in 2015, U.S. researchers used the gene-editing technique known as CRISPR to cut back the potentially harmful virus genes that have long hampered the successful use of pig organs. The CRISPR-Cas9 tool, which works as a type of molecular scissors that can selectively trim away unwanted parts of the genome, only started humantesting in China late last year and has yet to begin U.S. trials, but ithas seen much hype around its potential.

  The study, which showed that the pig genome can bedrastically edited to remove native pig viruses from pig cells, was led byeGenesis’ co-founder George Church, Ph.D., also a Harvard Medical Schoolgeneticist. It has yet to be shown to be safe in humans, however.

  Source: FierceBiotech

  

  2. 糖尿病管理数字健康公司Livongo Health获得5250万美元D轮融资

  概要:Livongo Health是一家专注于慢病管理研究和服务的公司,其开发的智能血糖管理平台可以为糖尿病患者提供移动端的个性化服务,使患者能够有效地管理自身疾病,并为他们的家人和医生提供信息。近日,Livongo获得5250万美元D轮融资,公司计划利用本轮融资加快现有业务增长速度,计划将服务范围拓展到其他如高血压、高胆固醇等慢性疾病的管理,并在未来几个月内进入国际市场。

  

  相关报道:

  Livongo Health scores $52.5 million to expand digital healthplatform

  Mar 17 , 2017

  Livongo Health has received a $52.5 million investment to broaden the reach of its digital health-management tools, including its flagship diabetes-management platform.

  The Mountain View, Calif.-based company will further develop its diabetes-management platform, expand the platform to include other conditions and move into international markets with the financing influx, according to CEO Glen Tullman.

  "If our goal is to keep people healthier, and we take care of their diabetes but we don't address their hypertension, high cholesterol ordepression, then we haven't really made them healthier,” Tullman said.

  Source: Modern Healthcare

  

  3.微创脊柱外科设备公司Vertiflex获4000万美元融资

  概要:位于加州的微创脊柱外科设备公司Vertiflex宣布获得了来自Endeavour Vision和H.I.G.BioHealth Partners领投的4000万美元融资。公司专注于研发微创脊柱外科设备,其独创的腰椎减压技术提供了为脊柱外科手术提供了新的手术方式。Vertiflex将用新获得的资金扩大其拳头产品Superion系统在美国的商业化推广,利用其独创的腰椎减压技术治疗中度腰椎管狭窄。

  

  相关报道:

  H.I.G. BioHealth Partners Invests in VertiFlex, Inc.

  Mar 15 , 2017

  H.I.G.and Endeavour Vision co-led the financing along side New Enterprise Associates,Thomas, McNerney & Partners, and Alta Partners. Proceeds from the financing will primarily be used to fund U.S. commercial expansion of the Company’sSuperion? Indirect Decompression System, a minimally invasive spinal implant designed to treat moderate lumbar spinal stenosis, a painful and often debilitating condition that affects an estimated 500,000 new patients every year in the United States.

  Source: BusinessWire

  

  并购

  1. ThresholdPharmaceuticals与Molecular Templates达成合并协议

  概要:纳斯达克(NASDAQ)上市公司海槛制药(ThresholdPharmaceuticals,NASDAQ:THLD)近日与分子模板(MolecularTemplates)宣布达成合并协议,合并后Molecular Templates股东将持有新公司65.6%股份,ThresholdPharmaceuticals将易名为Molecular Templates,以代码MTEM继续在纳斯达克挂牌上市,新的公司将继续从事抗癌创新药物的研发。

  

  相关报道:

  Threshold Pharmaceuticals, Molecular Templates to Merge

  Mar 17, 2017

  Molecular Templates will merge with a wholly owned subsidiary of Threshold Pharmaceuticals in an all-stock deal designed to create a combined developer of novel cancer treatments, the companies said today.

  Under the reverse merger, current Molecular Templates shareholders would own approximately 65.6% of the combined company, with the remaining 34.4% owned by shareholders of publicly traded Threshold. The combined company will bepublicly owned and will trade its stock on NASDAQ Capital Market under thesymbol MTEM, with Threshold changing its name to Molecular Templates.

  The merger comes nearly 6 months after Threshold acknowledged that its cancer candidate tarloxotinib met its primary interim response rate endpoint inpatients with recurrent or metastatic squamous cell carcinoma of the skin—but notin patients with metastatic squamous cell carcinoma of the head and neck, orpatients with advanced epidermal growth factor receptor (EGFR)-mutant,T790M-negative non-small-cell lung cancer.

  Source: GEN News

  

  行业盘点

  1.阿斯利康重磅新药ZS-9一年内第2次上市申请被拒

  概要:阿斯利康3月17日宣布收到FDA对其治疗高血钾症药物ZS-9上市申请的完全回复信(CRL)。这封CRL是FDA在核查ZS-9生产现场后发出。这是ZS-9继去年5月收到CRL之后,第二次因为生产问题收到FDA的CRL,引发投资人对该药上市前景的担忧,阿斯利康表示将配合FDA工作密切沟通这一问题。

  PS:ZS-9(锆环状硅酸钠)是一种治疗高血钾症的钾结合剂,最初由美国ZS制药公司研发,阿斯利康在2015年以27亿美元全现金收购ZS制药公司获得ZS-9的所有权。

  

  相关报道:

  AstraZeneca’s $2.7B ZS-9 rejected again by FDA

  Mar 17, 2017

  The FDA has rejected AstraZeneca’s hyperkalemia drug ZS-9 for the second time in 12months. The news marks a further blow for a program AstraZeneca saw giving it a sizable share of a $6 billion (€5.5 billion) market when it acquired the assetin its $2.7 billion buyout of ZS Pharma.

  Next tonothing has gone right for AstraZeneca and ZS-9 since then. The problems beganin May when the FDA rejected the drug—which was already being reviewed at the time AstraZeneca bought ZS Pharma—on the basis of observations made by its inspectors during a preapproval assessment of the ZS-9 manufacturing facility.Ten months later, AstraZeneca is still being dogged by regulatory concerns about the production of ZS-9.

  AstraZeneca revealed scant details in a release to disclose its latest FDA completeresponse letter (CRL). But in noting the rejection followed an FDA inspection of the ZS-9 production plant, AstraZeneca has again pointed to manufacturing problems as the source of its woes.

  In between the two CRLs, AstraZeneca picked up regulatory approval for ZS-9 in the European Union. But it needs to access the U.S. market if it is to begin racking up the sort of sales required to justify the price it paid for ZSPharma in 2015. At that time, the takeover looked like a direct route to blockbuster sales for AstraZeneca, and a blow to Relypsa’s attempts to cornerthe hyperkalemia market with its ZS-9 competitor Veltassa.

  Source: Fierce Biotech

  

  2. AveXis公司继续推进布SMA基因疗法床试验

  概要:AVeXis(NASDAQ:AVXS)近日公布了正在开展的AVXS-101在I型脊髓性肌萎缩(SMA)患者身上进行的临床I期试验数据更新,显示所有15个病人在13.6月龄时没有与治疗相关的安全事件发生,这对于该疾病的治疗研究是一个重大进展,积极的临床数据也促使AVeXis公司将在今年二季度开展通过静脉注射给药的关键临床试验。

  

  相关报道:

  AveXis SMA gene therapy advances toward pivotal trial

  Mar 17, 2017

  AveXishas posted top-line data from a phase 1 trial of its gene therapy againstspinal muscular atrophy (SMA). All 15 patients were event-free at 13.6 months of age, a significant improvement over the natural history of the disease.

  The phase1 gave three babies with the genetic muscle weakness disease a low dose of agene therapy designed to provide them with a functioning SMN gene. A further 12babies received the larger amount of the gene therapy AveXis sees as the proposed therapeutic dose. By the age of 13.6 months, none of the subjects hadsuffered an “event”, defined by AveXis as death or the need for medically prescribed respiratory assistance for 16 hours a day for two weeks.

  Withnatural history data suggesting 25% of babies with SMA would experience such anevent by 13.6 months of age, the results have encouraged AveXis to push aheadwith plans to start a pivotal trial of AVXS-101.

  “We planto initiate a pivotal trial in the U.S. of AVXS-101 via IV delivery in patientswith SMA type 1 in the second quarter of 2017, pending a successful outcome ofthe CMC type B meeting,” AveXis CEO Sean Nolan said in a conference call with investors to discuss the data.

  Source: Fierce Biotech

  

  3.川普总统第一预算案招致美国医药界猛烈抨击

  概要:美国总统川普(Donald Trump)对国会送出第一预算案,其中对生物医药相关领域有两项重大影响:一是削减美国国立卫生研究院(NIH)2018年预算58亿美元,二是美国食品和药物管理局(FDA)对药物和医疗器械的审查费用翻倍,2018年药厂需要支付给FDA的审查监管费用将由2017年的10亿美元调整到20亿美元。无论是美国的科学家还是医疗产业从业者对这项提案都感到大为光火。

  

  相关报道:

  Medical bodies slam Trump’s ‘devastating’ and ‘gutting’ researchcuts

  Mar 17, 2017

  PresidentDonald Trump’s first budget has not gone down well with the medical research and regulatory communities, which have come out against his plans to cut nearly$6 billion from the NIH and possibly double FDA user fees.

  ASCO,which represents 40,000 cancer docs and health professionals and runs the largest cancer research conference of the year, said starkly: “[The]President’s budget will devastate U.S. research enterprise.”

  It wenton: “We soundly oppose President Trump’s budget outline, which would cut $6billion from the National Institutes of Health (NIH). Reducing NIH’s funding bynearly 20% will devastate our nation’s already fragile federal researchinfrastructure and undercut a longstanding commitment to biomedical sciencethat has fueled advances in cancer prevention, diagnosis, and treatment.”

  Source: Fierce Biotech

  

  *声明:本文由入驻新浪医药新闻作者撰写,观点仅代表作者本人,不代表新浪医药新闻立场。