With $117M in fresh cash, Amu nix paves path to the clin ic for 'u ni ver sal mask' pro drug on the hunt for HER2 tu mors

有了1.17亿美元的新现金,阿穆尼克斯铺平了一条通往“U ni ver sal mask”专业药物的临床道路,以寻找她的母亲

2021-03-04 21:32:12 ENDPOINTS NEWS


De­spite all the ex­cite­ment over the pos­si­bil­i­ty of T cell ther­a­pies to crack the code against sol­id tu­mors, ear­ly safe­ty da­ta have lim­it­ed the bur­geon­ing field’s promise. A clutch of play­ers hope to solve that prob­lem by “mask­ing” their drugs, and now one of those out­fits has snared fresh in­vestor cash to take its shot in the clin­ic. Amu­nix closed a $117 mil­lion Se­ries B to guide AMX-818, a masked pro­tease-ac­ti­vat­ed T cell en­gager for HER2 ex­press­ing tu­mors, to the clin­ic as well as shep­herd­ing its bustling pipeline of tu­mor hunters through the pre­clin­i­cal stage, the com­pa­ny said Thurs­day. A 15-year-old firm that on­ly re­cent­ly piv­ot­ed its drug half-life ex­tend­ing plat­form in­to next-gen on­col­o­gy de­vel­op­ment, Amu­nix is one of a suite of com­pa­nies us­ing mask­ing an­ti­bod­ies to sneak ther­a­pies di­rect­ly in­to the tu­mor mi­croen­vi­ron­ment with­out the se­ri­ous safe­ty risks com­mon to oth­er im­munother­a­pies. What sep­a­rates Amu­nix from the pack? For one, the biotech is us­ing a “uni­ver­sal mask” for its im­munother­a­py drugs, CEO Ang­ie You told End­points News, which al­lows the team to “plug and play” against dif­fer­ent tar­gets where oth­er com­pa­nies are forced to de­sign cus­tom cloaks for each tar­get. “The tar­get uni­verse is huge, and our strat­e­gy is ‘look, we’re not lim­it­ed by good tar­gets,'” You said. The biotech’s lead can­di­date, for in­stance, tar­gets HER2 — a high­ly val­i­dat­ed and com­mon­ly tar­get­ed growth fac­tor pro­tein — but Amu­nix is al­so test­ing four ad­di­tion­al can­di­dates “in par­al­lel” to tar­get TROP2, PS­MA and EGFR, You said. Those pro­grams are less de­vel­oped, but Amu­nix still plans to nom­i­nate a sec­ond can­di­date for hu­man test­ing by the end of the year, she added. The first im­me­di­ate mile­stone for You’s team is tak­ing AMX-818 in­to the clin­ic. Amu­nix will ini­tial­ly launch its first hu­man tri­al in Spain and is scop­ing a CTA sub­mis­sion with the EMA by the end of the year to en­able pa­tient en­roll­ment by ear­ly 2022, You said. Go­ing af­ter HER2 is a bit of a dou­ble-edged sword: It’s a high­ly val­i­dat­ed tar­get but one with a ton of es­tab­lished com­pe­ti­tion. But You ar­gued all of those drugs tar­get tu­mors with high ex­pres­sion of HER2, leav­ing an un­tapped mar­ket in pa­tients with low- or mid-HER2 ex­pres­sion that are “over­ex­pressed” or am­pli­fied. “Some peo­ple have a knee jerk re­ac­tion like ‘it’s so crowd­ed,'” You said. “What’s emerg­ing is a lot of in­sti­tu­tions are screen­ing their pa­tients for HER2 be­cause it seems to be a mech­a­nism of re­ac­tion. We think there’s a lot of op­por­tu­ni­ty there.” In mouse da­ta pre­sent­ed in De­cem­ber, AMX-818 spurred com­plete re­spons­es even for tu­mors with low HER2 ex­pres­sion. That could of­fer a clue that AMX-818’s high po­ten­cy will of­fer a clin­i­cal ben­e­fit across the HER2 spec­trum, You said. But it’s not just T cell en­gagers on Amu­nix’s dock­et. The biotech is al­so chas­ing a pro­gram for masked, pro­tease-ac­ti­vat­ed cy­tokines that avoid T cells al­to­geth­er. That pro­gram is still “re­al­ly ear­ly,” You said, but could of­fer a nov­el path to cut­ting down tu­mors. With so much in the works, Amu­nix will look to great­ly ex­pand its team of 50 based in South San Fran­cis­co, You said. The biotech is al­so work­ing on part­nered drugs with Sanofi and 9 Me­ters, in­clud­ing a Fac­tor VI­II clot­ting drug with the French drug­mak­er that is cur­rent­ly in Phase III. Thurs­day’s round was led by Viking Glob­al Cap­i­tal and joined by new in­vestors in Bain Cap­i­tal Life Sci­ences, Black­Rock, Franklin Tem­ple­ton, Janus Hen­der­son In­vestors, Ar­row­Mark­Part­ners, Avid­i­ty Part­ners, Clough Cap­i­tal, and CaaS Cap­i­tal Man­age­ment. Ex­ist­ing in­vestors that jumped on board the new round in­clud­ed Red­mile Group, Ven­rock, Cas­din Cap­i­tal, Omega Funds, Fra­zier Health­care Part­ners, Lon­gi­tude Cap­i­tal and Po­laris Part­ners. The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights. Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates. Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another. Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans. You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies. Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world. The jury’s still out on whether the first wave of AI companies can significantly change drug development, but investors are increasingly buying into the hype. Exscientia, the decade-old UK machine learning outfit, announced Thursday that they’ve expanded their Series C, first announced in May, from $60 million to $100 million. The expansion most notably includes BlackRock, the private equity firm that has been wading deeper and deeper into biotech. They now join Novo Holdings, Bristol Myers Squibb and others among the company’s most recent backers. Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now. Let’s start with the latest data from Lilly. The EMA has started a rolling review of Sputnik V, the Russian vaccine that holds the dubious title of the world’s first registered jab for Covid-19. Seven months after the controversial clearance in Russia, Europe’s human medicines committee says it’s convinced to start looking at the application by data indicating that the adenovirus-based vaccine triggers the production of antibodies and immune cells against the SARS-CoV-2 coronavirus. It’s clear by now that biopharma experienced a massive boom in 2020, but a new report out Thursday says the Massachusetts hub was particularly successful. The trade group MassBio released its latest industry snapshot, summarizing the last calendar year as the most successful for the Massachusetts biopharma sector. Overall, Massachusetts-based biotechs raised $5.8 billion in 2020, marking a hefty 93% increase from the previous year. Gilead is chopping 179 jobs in its home state of California as it scales down its headquarters in favor of a hub in North Carolina. Up to half of the roles would shift to Research Triangle Park, where the company is setting up a new business services and information technology center, the San Francisco Chronicle reported. The precise number will depend on how many employees choose to relocate. Per a WARN notice filed with the state, the layoffs are expected to be effective May 30. Roughly three and a half months since its last fundraising round, the Peter Thiel-backed ATAI Life Sciences has pulled in its latest venture haul. The company closed a $157 million Series D round early Wednesday as it presses the gas on its psychedelics-based strategy. Though the short time between the two raises will likely fuel speculation about a potential jump to Nasdaq, ATAI isn’t ready to talk about that just yet, preemptively declining comment on all IPO-related questions.
尽管有关于T细胞可以破解密码的种种说法,但耳朵安全的技术已经兑现了燃烧场的承诺。一群玩家希望通过“伪装”他们的毒品来解决这个问题,现在其中一个已经网罗到了新的现金来投入临床。 该公司周四表示,阿姆斯特丹关闭了一个1.17亿美元的狮子座,以引导AMX-818(一个蒙面的T细胞收集器)进入临床,并将其繁忙的T细胞猎人输送到临床前的阶段。 一家有15年历史的公司,它的药物半衰期已经超过了下一代,它是一系列公司的一个,它的面具是一个偷偷的馅饼,与其他的馅饼之间的安全风险。 哪一个部门给阿穆尼克斯的评分?首席执行官Ang-ie You告诉End-Points News说,首先,生物技术是我们为其多种药物提供了一个“单一的面具”,这使得团队能够“即插即用”地对抗各种不同的焦油,在这种情况下,其他公司被迫为每种焦油提供一种“单一的面具”。 你说:“焦油量很大,我们的目标是‘看,我们不是被好的焦油量所吸引’。” 你说,生物技术的领先者可以获得HER2--一个高价值和低成本的增长因子--但Amu'nix正在测试四个“水平”,以获得TROP2、PSMA和EGFR。她补充说,这些项目的实施较少,但Amu-nix仍计划在今年年底为Hu-Man测试确定第二个测试日期。 你的团队的第一个目标是让AMX-818进入临床。你说,Amu'nix将在西班牙首次推出它的Hu'man Tri'al,并将在今年年底前与EMA合作推出CTA子Mission,并在2022年前推出。 离开HER2有点像一把双刃剑:它是一把价值很高的工具,但却有一大堆的问题。但你认为所有这些药物都有HER2的高表达,而在HER2的低表达或中表达的患者中留下了一个未开发的标记,即“过度表达”或被表达。 你说:“有些人会有一种‘太拥挤了’的感觉。”“现在的情况是,很多人都在为她筛选他们的朋友,因为这似乎是一种恢复的机制。”我们认为,这里面有很多问题,“ AMX-818在寄送的小鼠模型中,即使对HER2值较低的小鼠也能产生良好的效果。你说,这可能是一个线索,说明AMX-818的高性能将会在HER2的规格上有一个合适的性能。 但不只是在阿穆尼克斯的码头上的T细胞。生物技术正在研究一种能够避免T细胞被吸收的隐形的、有活性的细胞因子。你说,这个方案仍然是“很好的耳朵”,但可以找到一条减少噪音的新途径。 有这么多的工作中,阿穆尼克斯将期待伟大的前,和它的50个团队在南圣弗朗西斯科,你说。该生物技术正在与赛诺菲和9家公司合作研制部分药物,其中包括一种与法国药品制造商合作研制的Viii凝血药物,目前正处于第三阶段。 周四的活动由维京环球资本公司牵头,贝恩资本生命科学公司、黑岩公司、富兰克林资本公司、Janus Hender-Son资本公司、Arrow Mark资本公司、Avid资本公司、Clough资本公司和CaaS资本公司加入。加入新一轮的前几家公司包括红英里集团、Ven'rock、CAS'din Cap'i'tal、Omega Funds、Fra'zier Health Care Part.Ners、Lon'gi'tude Cap'i'tal和Po'laris Part.Ners。 这场全球大流行可能扰乱了经济,夺走了数十万人的生命,扼杀了整个行业,但它对生物制药风险投资的唯一影响是帮助该领域达到令人眩晕的新高度。 根据DealForma首席执行官Chris Dokomajilar的记录,以下是业内前100名风险投资家的排名,根据他们公开参与的交易数量排名。然后,数字大师计算出他们投入每笔交易的估计金额--按玩家人数分配现金--以表明他们是如何管理自己的辛迪加的。 在大卫·刘因发明基因编辑的新形式而出名之前,他在学术界的知名度在一定程度上是因为他的一项更默默无闻的创新:一种鲁伯·戈德堡式的系统,利用细菌感染的病毒获取一种蛋白质并将其转化为另一种蛋白质。 自2011年以来,刘的实验室使用了这套名为PACE的系统,梦想出梦幻般的新蛋白质:DNA碱基编辑器比原来的功能强大得多;基因编辑器Cas9的更多功能形式;杀灭抗药性虫子的杀虫剂;将合成氨基酸滑入生物体内的酶。但他们一直在努力掌握生物界最常见、最强大的蛋白质之一:蛋白酶,这是一组瑞士军刀酶,可以切割、裂解或撕碎从病毒到人类的任何事物中的其他蛋白质。 如果你认为Biogen公司唯一的研发成果是阿多卡努单抗,这是一种备受争议的老年痴呆症药物,那你就可以原谅了。但在围绕这种药物的喧嚣背后,这家大型生物技术公司正在进行全面的研究,其中包括对开发基因疗法的日益关注。 现在Biogen计划建立一种制造肌肉,使其在获得FDA批准方面具有优势--CMC始终是关键--然后在世界各地销售。 人工智能公司的第一波浪潮能否显著改变药物开发,目前还没有定论,但投资者越来越多地买进了这场炒作。 拥有十年历史的英国机器学习公司Exscientia周四宣布,他们将5月首次宣布的C系列产品的规模从6000万美元扩大到1亿美元。最引人注目的扩张包括私人股本公司贝莱德,该公司在生物技术领域越陷越深。他们现在加入了Novo Holdings,Bristol Myers Squibb和其他公司的最新支持者行列。 礼来并不只是在寻找一种更好的糖尿病药物替西帕肽。他们还想在肥胖方面超越诺和诺德的劲敌奥赞比克(赛马鲁肽)。但是,新宣称的在第三阶段关于减少A1C同时减磅的正面对决中获胜--有明显的证据表明它优于已批准的竞争对手--可能会证明现在很难卖出。 先从礼来的最新数据说起。 EMA已经开始对俄罗斯的Sputnik V疫苗进行滚动审查,该疫苗被称为世界上首个注册的新冠疫苗。 在俄罗斯获得这一有争议的批准7个月后,欧洲人类药物委员会表示,有数据表明,以腺病毒为基础的疫苗会引发针对新型冠状病毒冠状病毒的抗体和免疫细胞的产生,因此该委员会确信将开始研究这一申请。 现在很明显,生物制药在2020年经历了一个巨大的繁荣,但周四发布的一份新报告说,马萨诸塞州的中心尤其成功。 贸易组织MassBio发布了最新的行业快照,总结了过去一年是马萨诸塞州生物制药行业最成功的一年。总体而言,总部位于马萨诸塞州的biotechs在2020年筹集了58亿美元,比上年大幅增长93%。 Gilead在其总部所在地加利福尼亚州裁减了179个工作岗位,并将总部设在北卡罗来纳州。 据《旧金山纪事报》报道,多达一半的职位将转移到Research Triangle Park,该公司正在那里建立一个新的商业服务和信息技术中心。确切的数字将取决于有多少员工选择搬迁。 根据向该州提交的警告通知,裁员预计将于5月30日生效。 距离上一轮融资大约三个半月,彼得•泰尔支持的阿泰生命科学公司已经收获了最新的投资成果。 周三早些时候,该公司结束了1.57亿美元的D轮投资,因为它正在对其以迷幻剂为基础的战略施加压力。虽然两次上调之间的时间很短,可能会引发外界对纳斯达克IPO可能跳水的猜测,但安泰暂时还没有准备好谈论这个问题,先发制人地拒绝就所有与IPO相关的问题置评。