Fresh off $1B+ Mer ck deal, Janux locks down first pri vate fundraise for its T cell en gagers

Janux刚刚完成了10亿美元+Mer ck的交易,为其T细胞计数锁定了第一笔原始资金

2021-03-04 03:30:13 ENDPOINTS NEWS


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. CEO David Camp­bell told End­points News that the Mer­ck deal, on top of the da­ta that had al­ready im­pressed a num­ber of in­vestors, helped get Wednes­day’s fi­nanc­ing across the fin­ish line. All the buzz has cen­tered around Janux’s T cell en­gager plat­form called TRAC­Tr, which the com­pa­ny says can de­vel­op drugs that al­ter their phar­ma­co­ki­net­ics de­pend­ing on the con­text. Up­on ac­ti­va­tion in a tu­mor, its can­di­dates are con­vert­ed from their orig­i­nal form — which can re­main in the blood­stream for over 100 hours — to a T cell en­gager that on­ly cir­cu­lates for less than an hour. Janux al­so says any T cell en­gager that es­capes from the tu­mor mi­croen­vi­ron­ment is quick­ly elim­i­nat­ed, fur­ther tamp­ing down tox­i­c­i­ty lev­els and pre­vent­ing buildup in healthy tis­sue. And the com­pa­ny al­so has mon­key da­ta that show in­hi­bi­tion of cy­tokine re­lease at greater than 200-fold high­er dos­es, and greater than 2,000-fold high­er plas­ma lev­els, than ear­li­er gen­er­a­tion T cell en­gagers. These three fac­tors, im­proved phar­ma­co­ki­net­ics, low­er tox­i­c­i­ty and bet­ter pre­ven­tion of cy­tokine re­lease, are where Janux is hop­ing to dif­fer­en­ti­ate it­self from oth­er T cell en­gager plat­forms, Camp­bell said. That’s true not just for its PS­MA and TROP2 pro­grams, but the oth­er can­di­dates fur­ther down the pipeline like an EGFR en­gager. Janux plans to pur­sue prostate can­cer with the PS­MA pro­gram, with Camp­bell say­ing their pre­clin­i­cal da­ta have shown a “clear” path for­ward in the in­di­ca­tion. Re­searchers are go­ing to start eval­u­at­ing the can­di­date as a monother­a­py in lat­er lines of the dis­ease, but in the fu­ture may look to ex­pand the tar­get pa­tient pop­u­la­tion by com­bin­ing the pro­gram with check­point in­hibitors. “We’re go­ing to come in with a once-week­ly dose drug that we ex­pect, based up­on the pre­clin­i­cal da­ta that we’ve gen­er­at­ed, will be able to cir­cum­vent the cy­tokine re­lease syn­drome that has im­pact­ed many of the pro­grams in this par­tic­u­lar space,” Camp­bell said. The TROP2 can­di­date is like­ly to go af­ter triple neg­a­tive breast can­cer and non-small cell lung can­cer. TROP2 is the same tar­get for the Gilead/Im­munomedics drug Trodelvy, whose ap­proval in triple neg­a­tive breast can­cer this past April has helped Janux val­i­date the tar­get as a vi­able ap­proach, Camp­bell said. Camp­bell said Janux is plan­ning to off­set this can­di­date’s first clin­i­cal tri­al by a quar­ter sim­ply be­cause the com­pa­ny is still build­ing out its small staff from 10 em­ploy­ees to about 35 to 40. Wednes­day’s fund­ing will help them ac­com­plish that goal as well, en­sur­ing both pro­grams can hit the ground run­ning when their first hu­man tri­als even­tu­al­ly launch next year. Ex­ist­ing in­vestors Bregua and Cor­re­la­tion Ven­tures al­so con­tributed to the Se­ries A. 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. 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. 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. 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.
自2017年被发现以来,Janux Ther'a'peu'tics一直保持着相当低的价格,但去年年底Mer'ck为其T细胞检测仪投入了超过10亿美元的承诺中的千里石,这让Janux Ther'a'peu'tics突然出现。现在,不到三个月后,这家小型生物技术公司已经获得了第一轮由一些项目后盾领导的原始基金。 Janux公司在为INDs准备第一批项目的同时,在周三上午投入了5600万美元的资金,杰伊·利希特的Aval on Ventures加入了新的Investors或Bimed和RA Capital Man的力量,为该公司提供资金。“Janux”公司在周三上午投入了5600万美元的资金,“JayLichter”Aval on Ventures“JayLichter”Aval on Ventures“JayLichter”Aval on Ventures“。Janux公司将用这笔钱购买其T细胞计数仪,以获得PSMA和TROP2,这两种仪器预计将在2022年第一和第二季度投入使用。 首席执行官大卫•坎贝尔告诉《终点新闻》,在已经准备好的一批投资者的基础上,并购交易帮助周三的业绩越过了底线。 所有的喧嚣都围绕着Janux的T细胞计数表单(称为TRAC-TR)而展开,该公司表示,该表单可以将药物的药效学分析结果显示在该表单上。在一个时间里,它的细胞周期从其原始形式(可以在血液中主要循环100小时以上)转变为T细胞周期不到一个小时。 Janux al…so说,任何T细胞都是快速转化的,它会使毒素水平下降,并使其在健康状态下积累。和2000倍以上的高密度水平的细胞比耳传代细胞高密度水平的细胞有更高密度的细胞比耳传代细胞高密度水平的细胞比耳传代细胞高密度水平的细胞更高密度。 坎普·贝尔说,这三个因素,即改进的PHARMACOKINET、低毒性和更好的毒性再租赁,是Janux与其他T细胞免疫平台相区别的地方。这是正确的不仅是它的PSMA和TROP2 program,但oth-er可以di日期毛皮在管道中像一个EGFR engager。 Janux计划用PSMA方案来治疗前列腺癌,Camp Bell说,他们的前临床数据显示了一条“清晰”的治疗路径。搜索者正在去开始评估在后面的线上的罐头日期,但在未来可能会期待通过与检查点在展商合作的项目和焦油得到数据的流行。 坎普·贝尔说:“我们将提供一周一次的药物,根据我们已经提供的前临床数据,我们将能够在这一特定的空间中提供许多项目。” TROP2可以分为三组:乳腺细胞和非小细胞肺细胞。Camp Bell说,TROP2与Gilead/immunomedics药物Trodelvy相同,该药物在今年4月的三次乳腺抑制试验帮助Janux将TROP2作为一种有效的药物。 坎普贝尔公司说,简纽公司正计划通过一个大规模的模拟来取代这一公司的第一个分支机构,因为该公司的员工人数仍然很少,从10人增加到35至40人。周三的基金也将帮助他们实现这一目标,只要他们的第一个Hu-Man Trial明年推出时,这两个项目都能落地。 在布列瓜岛和阿尔索岛上向Se.致敬的布列瓜岛和阿尔索岛上的布列瓜岛上的布列瓜岛上的布列瓜岛上的布列瓜岛上的布列瓜岛上的布列瓜岛。 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。 欧洲最受瞩目的生物制药投资者之一将获得5.4亿美元,投资于新的跨界交易,为处于后期阶段的公司投资。 这家总部位于巴黎的风投公司表示,新的Sofinnova跨界基金融资使他们成为“欧洲最大的跨界投资者,致力于后期生物制药和医疗技术投资”。 他们在法国获得了法国政府颁发的“Tibi”特许权,从而获得了60亿欧元的资金池,帮助他们在机构投资者中获得了优势。自50年前成立以来,这家风险集团已经支持了500多家公司,目前管理着超过20亿欧元的资金。 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。 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。