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本草圈企业|祝贺 Ansun Biopharma入选2018年度“Fierce 15”生物技术公司

美国时间2018年10月2日,FierceBiotech公布业界瞩目的年度 "Fierce 15"生物技术公司。本草已投公司Ansun Biopharma位列其中,被视为业内最有前景的未上市生物技术企业之一。

美国时间10月2日,FierceBiotech发布了2018年全球最强生物技术初创公司TOP15榜单——2018 Fierce 15。这份榜单由前FierceBiotech主编&资深编辑John Caroll(目前是Endpoints News创始人&主编)一手打造,已经连续发布多年,在全球生物制药产业界具有深远的影响力。上榜企业代表了诸多有可能满足未来临床需求的创新前沿,通常都会成为大型药企追逐并购的对象。
2018年的Fierce 15榜单由FierceBiotech的高级编辑Ben Adams负责推出。他在榜单引言中提到:“今年9月初福布斯的一组统计数据显示,全球风投机构(VCs)对医疗健康初创企业的投资总额创了新记录,今年前8个月共向这个领域投资200亿美元(涉及1186个项目),相比2017年同期增长了59%,相比10年前同期更是增长了180%。生物医药领域的投资热度在 Fierce 15的数据上也有体现,这15家企业已经累计完成了13.6亿美元的融资,其中融资最多的5家超过了1亿美元,其他大多月4000万~6000万美元之间。融资虽然并不能代表一切,还需要用研发成果证明自己,但至少这些企业有资金、有机会把自己的愿景变成现实。”

Ansun是一家致力于开发针对呼吸道病毒的独特宿主靶向抗病毒疗法的生物制药公司,核心产品是用于治疗副流感和流感的first in class新药DAS181。

副流感是一种不严重但可致命(特别是对于伴有免疫减退的患者,比如接受造血干细胞移植)的疾病,目前尚无任何疗法获批用于治疗副流感。DAS181获得了FDA授予的治疗伴有免疫减退的下呼吸道副流感病毒感染患者的突破性疗法和快速通道资格认定,目前处于II期阶段。

Ansun今年5月完成了8500万美元A轮融资,计划开展DAS181针对感染副流感病毒的住院免疫减退患者的III期临床试验。据Ansun发布数据,每年有大约5.5万~20万住院患者感染副流感病毒,如果病毒感染侵犯下呼吸道,死亡率在13%~63%之间。Ansun还计划开发DAS181的流感适应症,包括对其他药物产生耐药的流感病毒株,和包括H7N9、H5N1和H1N1以及许多其它病毒在内的大流行病毒株。

DAS181是一种重组唾液酸酶蛋白,通过吸入给药,可以切割位于人体呼吸道上皮细胞表面的病毒受体唾液酸,阻止病毒进入呼吸道上皮细胞,从而防止病毒感染和传播,作用机制与当前的流感药物(比如罗氏的口服唾液酸酶抑制剂奥司他韦)有明显不同,可以为临床治疗提供新的选择或作为补充手段。

此外,Ansun 还曾报道过DAS181可以阻断呼吸道合胞体病毒和人偏肺病毒。除了DAS181之外,Ansun的研发管线中还有4款处于临床前阶段的候选药物,比如治疗人多瘤病毒BK和JC的ANSXEV68。

Ansun Biopharma FierceBiotech's 2018 Fierce 15

Developing new biologic drugs for tough-to-treat viral diseases 


CEO: Nancy T. Chang

Based: San Diego
Founded: 2002
Clinical focus: Viral respiratory tract infections

The scoop: After years operating under the radar, Ansun Biopharma (formerly NexBio) is building momentum behind a portfolio of biologic drugs for viral infections, headlined by DAS181, a first-in-class therapy in midstage testing for parainfluenza and influenza. At the moment there are no approved treatments for parainfluenza, which isn't usually a serious infection but can be life-threatening in people with compromised immune systems, such as those undergoing hematopoietic stem cell transplant. That’s why the FDA has awarded its breakthrough therapy designation as well as fast-track status for DAS181 in this indication.

What makes Ansun fierce: Armed with an $85 million series A fundraising earlier this year, the company is in the final stages of preparation for phase 3 testing of its Paradase formulation of DAS181 in hospitalized, immunocompromised patients with parainfluenza virus, a group estimated to have a mortality rate of 13% to 63% if the infection reaches the lower respiratory tract. Between 55,000 and 200,000 hospitalized patients are diagnosed with parainfluenza virus infections every year, the company says.

Ansun is also planning testing in influenza, reckoning that DAS181 could provide a new treatment option, including for drug-resistant, potentially pandemic strains such as H7N9, H5N1 and H1N1. Flu remains a major cause of death worldwide, leading to severe disease in 3 million to 5 million people every year and causing around 650,000 deaths.

DAS181 is a recombinant sialidase fusion protein, delivered by inhalation, that's designed to cleave and block sialic acid receptors used by viruses to penetrate cells lining the respiratory tract, preventing viral replication. That means it works differently from—and could complement—current antivirals used for flu, such as Roche’s oral neuraminidase inhibitor Tamiflu (oseltamivir), which was launched 20 years ago but, despite generic competition in some markets, remains a big earner for the company with sales of more than $500 million last year.

Tamiflu, however, isn’t effective for some pandemic variants of the virus. A phase 2 clinical trial of DAS181 in otherwise healthy adults with influenza A or B showed a significant decrease in viral load with the drug—known as Fludase for this indication—and the U.S. government has provided around $100 million in funding to help bring the program forward, in the hope that it may be useful for pandemic stockpiling.

A couple of years ago, Ansun reported that DAS181 also seems to block the attachment of two other respiratory pathogens—respiratory syncytial virus and human metapneumovirus—which could open new avenues of research for the drug. And following DAS181 in its pipeline are four more drug candidates in preclinical development, headed by ANSXEV68 for human polyomaviruses BK and JC, which are generally benign but can cause serious infections in immunocompromised people and have also been linked to some cancers.

Investors: Sinopharm Healthcare Fund, Lilly Asia Ventures, Yuanming Capital, Lyfe Capital, Oceanpine Capital, VI Ventures, Matrix Partners China, 3E Bioventures Capital, Joincap Investment