The 2021 top 100 bio phar ma in vestors: As the pan dem ic hit and IPOs boomed, VCs swung in to ac tion like nev er be fore

2021年百强生物并购:随着泛集成电路的流行和IPO的繁荣,风投们纷纷涌入,比如nev er be fore

2021-03-03 23:00:55 ENDPOINTS NEWS


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. In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders? Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday. Soticlestat made it. Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones. Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one. Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms. About three years after acquiring SteadyMed and its experimental pulmonary arterial hypertension drug Trevyent, United Therapeutics has decided to kick the program to the curb. In an 8-K form filed with the SEC on Tuesday, United revealed that they are shutting down development of Trevyent after receiving feedback from the FDA last week. The move marks the end of a long and bumpy road for the program, which had previously earned an RTF in 2017 and a CRL last April, as United moves forward with new Tyvaso formulations. The outsourcing market for cell and gene therapies has stayed red-hot in recent months as some of the biggest CDMOs — and even major drugmakers — are diving in. Now, a Swiss CDMO wants a bigger piece of the action, and it’s looking to set up shop in Novartis’ fledgling life sciences hub in Stein. Celonic plans to build a 91,500-square-foot manufacturing center focused on cell and gene therapies, next-gen vaccines and other “innovative” drugs as part of a two-part expansion at Novartis’ Rhine Valley hub, the CDMO said last week. Janux Therapeutics had kept a relatively low profile since being founded back in 2017 but burst onto the scene late last year when Merck plunked down more than $1 billion in promised milestones for its T cell engagers. Now, less than three months later, the small biotech has clinched its first round of private funding led by some prominent backers. As it prepares its first programs for INDs, Janux completed a $56 million Series A on Wednesday morning, with Jay Lichter’s Avalon Ventures joining forces with new investors OrbiMed and RA Capital Management to fund the company. Janux will use the cash to primarily advance its T cell engagers targeting PSMA and TROP2, which are expected to hit the clinic in the first and second quarters of 2022, respectively. There is no shortage of biotechs pursuing off-the-shelf CAR-Ts, a so-called Holy Grail in oncology R&D. Now, less than a month after teaming up with AbbVie, a California player launched by CRISPR pioneer Jennifer Doudna has returned to the venture well, scooping up a big crossover round to help it along. Caribou Biosciences took the wraps off a $115 million Series C on Wednesday morning, bringing their total raise to around $157 million, CEO Rachel Haurwitz said. Merck spent $425 million to buy out OncoImmune in November, presumably under the belief that they could scale up their drug for severe Covid-19 and get it through the FDA on the strength of a Phase III trial the smaller biotech completed in September. The FDA threw a wrench in those plans. The agency told Merck last week that the 203-person study wasn’t sufficient to show the drug was effective. Now, Bloomberg reports, Merck is preparing an additional Phase III study, one that will push results — and any chance of approval — back to the end of the year. Lalo Flores is confident he’s found the way forward in cell therapy. The feeling, to be sure, is not exclusive. Thanks to splashy companies like Allogene, Lyell and Artiva, biopharma is well aware of the promises of allogeneic therapies as next-generation alternatives to the autologous CAR-Ts that have already made it to the market. But fewer are talking about a finer distinction within that allogeneic group: Where do you find the cells to engineer and turn into a final off-the-shelf product?
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。 去年年底,FDA命令百时美施贵宝放弃Opdivo在SCLC的审批,这可能是对那些利用验证性研究来支持加速审批的制药商的一次早期打击。现在,默克是下一个上火线的--我们看到FDA对上市后违法者的严厉打击了吗? 默克公司周一表示,该公司已经撤回了对转移性小细胞肺癌的PD-(L)1抑制剂Keytruda的上市批准,作为FDA对不符合上市后检查点的药物进行“全行业评估”的一部分。 索蒂克莱斯塔特成功了。 在委托奥维德大学的研究小组进行中期临床工作四年多后,竹田正将这种药物重新纳入自己的阵营。由于所有这些--在Dravet综合征和Lennox-Gastaut综合征中产生了他们认为是积极的第二阶段数据--生物技术公司获得了1.96亿美元的预付现金,另外6.6亿美元用于监管和商业里程碑。 过去十年,制药商已经证明JAK抑制剂可以治疗从类风湿性关节炎到COVID-19等一小部分免疫相关疾病。现在礼来又拿出了一个新的。 礼来及其生物技术合作伙伴Incyte周三宣布,他们的JAK抑制剂baricitinib在一项针对斑秃的III期试验中有效地修复了患者的头发。斑秃是一种会导致突然、严重和斑片状脱发的自身免疫性疾病。礼来没有对546名患者的试验结果进行分析,但主要终点是脱发症状标准评分的改善。 在收购SteadyMed及其实验性肺动脉高压药物Trevyent约三年后,联合治疗公司决定终止该项目。 在周二提交给SEC的8-K表格中,美联航透露,在上周收到FDA的反馈后,他们将关闭Trevyent的开发。这一举动标志着该项目漫长而坎坷的道路的结束,此前该项目曾在2017年获得RTF奖,去年4月获得CRL奖,同时曼联也在推进新的Tyvaso配方。 近几个月来,细胞和基因疗法的外包市场一直处于火热状态,因为一些最大的CDMO(甚至是主要的制药商)纷纷涉足。现在,一家瑞士CDMO想要分得更大的一杯羹,它正打算在诺华公司位于斯坦因的新生生命科学中心开店。 CDMO上周表示,赛隆公司计划在诺华莱茵河谷中心分两部分进行扩建,计划建设一个占地9.15万平方英尺的制造中心,专注于细胞和基因疗法、下一代疫苗和其他“创新”药物。 Janux Therapeutics自2017年成立以来一直保持着相对低调的姿态,但去年年底,默克公司斥资逾10亿美元,承诺为其T细胞参与器提供一系列里程碑项目,这让Janux Therapeutics突然崭露头角。现在,不到三个月后,这家小型生物技术公司已经获得了由一些知名支持者牵头的第一轮私人融资。 Janux在为INDs准备第一个项目的同时,于周三上午完成了5600万美元的a轮融资,由Jay Lichter的Avalon Ventures联合新的投资者OrbiMed和RA Capital Management为该公司提供资金。Janux公司将利用这笔资金主要推进针对PSMA和TROP2的T细胞接合器,预计将分别于2022年第一季度和第二季度投入临床应用。 生物技术公司也不乏追求现成的CAR-Ts,这是肿瘤研发领域的一个所谓的圣杯。现在,在与AbbVie合作不到一个月后,CRISPR的先驱Jennifer Doudna推出了一款加利福尼亚的player公司,它很好地回到了这家公司,并获得了一个很大的跨界回合来帮助它前进。 Caribou Biosciences首席执行官雷切尔·豪尔维茨说,周三上午,Caribou Biosciences完成了1.15亿美元的C轮融资,使他们的融资总额达到1.57亿美元左右。 去年11月,默克公司斥资4.25亿美元收购了OncoImmune,大概是因为他们相信,他们可以扩大其治疗重症Covid-19的药物的规模,并借助9月份完成的一项III期试验(规模较小的biotech)通过FDA的审批。 FDA否决了这些计划。该机构上周告诉默克公司,这项203人的研究并不足以证明这种药物是有效的。据彭博社报道,默克公司正在准备一项新的第三阶段研究,这项研究将把结果和任何批准的机会推到今年年底。 Lalo Flores有信心在细胞治疗方面找到了前进的方向。 当然,这种感觉并不是排他性的。多亏了Allogene、Lyell和Artiva这样的知名公司,biopharma公司非常清楚异体疗法作为自体CAR-Ts的下一代替代品的前景,自体CAR-Ts已经投放市场。但很少有人谈论在异体群体中的更精细的区别:你在哪里找到细胞来进行工程并转化成最终的现成产品?