Sofinno va Part ners stays fo cused on late-stage deals with a new, $540M crossover fund

Sofinno va Part ners将继续在一个5.4亿美元的新交叉基金的后期交易中留任

2021-03-04 03:30:12 ENDPOINTS NEWS

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One of Eu­rope’s most high-pro­file bio­phar­ma in­vestors is get­ting $540 mil­lion to in­vest in new crossover deals for late-stage com­pa­nies. The Paris-based VC says the fresh Sofinno­va Crossover Fund raise po­si­tions them as the “largest crossover in­vestor in Eu­rope ded­i­cat­ed to late-stage bio­phar­ma and medtech in­vest­ments.” They got a leg up in France af­ter win­ning a spe­cial “Tibi” des­ig­na­tion from the French gov­ern­ment, giv­ing them ac­cess to a pool of €6 bil­lion that helped them gain an edge with in­sti­tu­tion­al in­vestors. Since they were found­ed close to 50 years ago, the ven­ture group has backed more than 500 com­pa­nies and cur­rent­ly has more than €2 bil­lion un­der man­age­ment. While typ­i­cal­ly fo­cused on Eu­rope pri­mar­i­ly, Sofinno­va Part­ners has al­so tra­di­tion­al­ly re­served a slice of its in­vest­ment cap­i­tal for US biotechs. “Eu­ro­pean bio­phar­ma and medtech com­pa­nies have ma­tured tremen­dous­ly in the last decade,” says Sofinno­va Part­ners man­ag­ing di­rec­tor An­toine Pa­piernik. “Sofinno­va Part­ners was the first Eu­ro­pean VC to seize the op­por­tu­ni­ty to un­lock the po­ten­tial of these high-growth start-ups by pro­vid­ing late-stage cap­i­tal, build­ing on our decades of ex­pe­ri­ence fund­ing in­no­v­a­tive life sci­ence com­pa­nies.” 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 Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the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. 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. CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means. Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society. GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan. The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday. A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement. The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance. 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. 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. 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.
Europe最具竞争力的生物并购公司之一将获得5.4亿美元,用于为后期企业进行新的跨界交易。 这家总部位于巴黎的风投表示,新的Sofinno-va跨界基金将他们视为“欧盟最大的跨界基金,涉及到后期生物制药和医疗技术领域。” 他们在法国赢得了法国政府颁发的一个特别“提比”奖,给他们提供了一个6百亿欧元的奖金池,帮助他们在法国取得了优势。自从他们在近50年前被发现以来,该集团已经支持了500多家公司,而Currentally拥有超过20亿欧元的人力资源。 虽然典型的做法是在欧盟的原则上,但Sofinno-va Part-ners已经为我们的生物技术重新服务了它的一部分。 “欧盟生物制药公司和医疗技术公司在过去十年中取得了巨大的成就,”Sofinno-va Partners Man-ag Di Rector Antoine Pa Piernik说。“Sofinnova Part.ners是第一个抓住这些高增长初创企业机会的欧洲风险投资公司,通过支持后期投资,建立在我们几十年的前投资基金的基础上。” 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。 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。 CRLS.483s.CBER、CDER和RWE。对于生物制药专业人员来说,这些首字母缩略词之所以引起注意,是因为FDA在药物开发中起着重要作用。现在Endpoints正在加倍扩大监管覆盖范围,并推出一份关注White Oak公司发展的周报,并对这一切意味着什么进行分析和洞察。 报道将由我们新的高级编辑Zachary Brennan领导。他加入了POLITICO的端点,在那里他报道了制药。在此之前,他是管理事务专业人士协会的新闻刊物《管理焦点》的执行编辑。 葛兰素史克公司和Vir Biotechnology公司在接到NIH一项针对住院Covid-19患者的重大研究的邀请后,希望他们合作的抗体之一能够赢得胜利。但就像礼来一样,这对组合的药物不能击中目标,现在他们将被留在认真看比赛计划。 合作伙伴周三表示,NIH已经停止了GSK和Vir的抗体VIR-7831在其晚期Active-3试验中的注册,因为该药物在实现住院的Covid-19患者的持续康复方面显示出可忽略不计的效果。 一周多一点后,BrainStorm公司承认FDA的监管机构已经通知他们,该生物技术公司需要更多的数据才能获得ALS治疗NurOwn的批准--同时仍在吹捧疗效的“明确信号”,并不排除申请--该机构决定在一份最不寻常的声明中澄清记录。 FDA的声明完全是对自己的一记耳光,它提供的药效数据与该公司去年11月的公开声明不同,并且排除了任何统计意义的可能性。 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。 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。 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。

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