Pfiz er's in vest ment fund is mak ing waves in VC — in clud ing a $25M bet on IBD play er Vedan ta Bio sciences

Pfiz er'sInvestment fund在风险投资领域掀起了波澜,包括对IBD公司er Vedan ta Bio sciences的2500万赌注

2021-01-14 03:00:13 ENDPOINTS NEWS

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Pfiz­er has a gut feel­ing about Vedan­ta Bio­sciences. On Tues­day, the Cam­bridge, Mass­a­chu­setts-based mi­cro­bio­me up­start be­came the fourth biotech to re­ceive an in­vest­ment from the Pfiz­er Break­through Growth Ini­tia­tive (PG­BI), bag­ging $25 mil­lion to send its in­flam­ma­to­ry bow­el dis­ease can­di­date to Phase II. Since its launch in June, the PG­BI has in­vest­ed $120 mil­lion in small- to medi­um-sized biotechs span­ning sev­er­al key fo­cus ar­eas: in­ter­nal med­i­cine, in­flam­ma­tion and im­munol­o­gy, on­col­o­gy, rare dis­ease, vac­cines and hos­pi­tal. So far, Ho­mol­o­gy Med­i­cines has the largest stake, with $60 mil­lion to ad­vance its phenylke­tonuria (PKU) pro­gram. In­spired by the abil­i­ty of fe­cal trans­plants to re­boot the bal­ance of healthy mi­crobes in the gut, Vedan­ta is work­ing on tai­lored pack­ages of bac­te­r­i­al strains de­signed to spur spe­cif­ic ther­a­peu­tic re­spons­es. The com­pa­ny says Pfiz­er’s in­vest­ment will fund a Phase II tri­al for its live bio­ther­a­peu­tic to treat IBD — dubbed VE202 — which is ex­pect­ed to launch this year. VE202  is pro­duced from pure, clon­al bac­te­r­i­al cell banks, by­pass­ing the need for di­rect sourc­ing of fe­cal donor ma­te­r­i­al. Topline Phase I da­ta showed VE202 was gen­er­al­ly safe and well-tol­er­at­ed, and “demon­strat­ed durable and dose-de­pen­dent col­o­niza­tion,” Vedan­ta said. “We be­lieve Vedan­ta’s ap­proach to mod­u­lat­ing the mi­cro­bio­me may hold promise for peo­ple liv­ing with IBD, and we are ex­cit­ed for its po­ten­tial as this im­por­tant study moves for­ward,” Michael Vin­cent, se­nior VP and CSO of Pfiz­er’s in­flam­ma­tion and im­munol­o­gy re­search unit said in a state­ment. Vin­cent is join­ing Vedan­ta’s sci­en­tif­ic ad­vi­so­ry board, and Pfiz­er holds rights to first ne­go­ti­a­tion on VE202. Mer­ck and Ab­b­Vie vet Jef­frey Sil­ber is lead­ing Vedan­ta’s ef­forts as CMO af­ter join­ing the com­pa­ny back in Sep­tem­ber. Ho­mol­o­gy and Vedan­ta aren’t the on­ly two Mass­a­chu­setts-based biotechs to ben­e­fit from the PG­BI. Cam­bridge-head­quar­tered Tril­li­um Ther­a­peu­tics al­so snagged a $25 mil­lion in­vest­ment for its CD47 pro­gram. ES­SA Phar­ma, lo­cat­ed in Van­cou­ver, British Co­lum­bia, re­ceived a $10 mil­lion in­vest­ment for its work in the prostate can­cer space. “Now, more than ever, our pa­tients need us, work­ing to­geth­er, to turn great sci­en­tif­ic ideas in­to in­no­v­a­tive new med­i­cines,” Pfiz­er said in a state­ment in June. Kathy High has re-emerged in the gene therapy space just as unexpectedly as she left Spark Therapeutics close to a year ago. Her newest title will be president, therapeutics at AskBio, the biotech “race horse” that Bayer has just bought for $2 billion cash to build a cell and gene therapy unit around. On the surface, the circumstances are not unlike Spark, which was getting absorbed into Roche following a $4.3 billion buyout. High, 68, was credited for both steering Luxturna toward an approval for a rare inherited eye disease caused by mutations in the RPE65 gene, setting up gene therapy research in hemophilia A and leading a Phase I/II trial for hemophilia B. One of the iconic brands in biopharma, Pfizer took a big gamble on the strength of its in-house science when it decided to offload its flagging Upjohn generics business last year. Now, a more agile Pfizer is looking to cement its identity for the future, but one thing will stay the same: M&A is still very much a part of the game plan. With its Upjohn generics business off the books, Pfizer is looking to double down on its branded medicines with the goal of hitting 6% annual growth each year — previously unheard-of at old Pfizer — while continuing to develop its blockbuster pipeline, CEO Albert Bourla said at a JP Morgan fireside chat Tuesday. Less than a month after achieving breakthrough therapy designation in melanoma, IO Biotech has secured an oversubscribed Series B that will help them get their immune-modulating IDO and PD-L1 cancer vaccines through a late-stage trial. The Copenhagen-based company netted €127 million ($154.5 million) in the round, it revealed Wednesday morning, raising the stakes for its T cell activating therapies. It’s the biggest fundraise for the biotech since its founding in conjunction with Novo Seeds in 2014, when it pulled in an amount more than 11 times higher than its Series A about four years ago. In August 2018, a tiny biotech spinout from Cornell announced they had hired former high-ranking Pfizer executive Geno Germano as CEO. And then they said nothing else. For two years. Literally, the company, called Elucida Oncology, did not issue a single other press release until this past October, when they hired a chief medical officer. Now, though, Elucida seems to be ready to start taking the lid off their operations. On Tuesday at JP Morgan, Germano walked investors through the nanoparticle technology they’ve been developing for cancer. And the same day, the company announced a new financing, raising $44 million in a Series “A-1” round meant to propel them into the clinic this year. By now, Bayer has sketched out in bold strokes some grand plans for cell and gene therapy, cemented by big-dollar acquisitions of platform companies. But just how do you stitch together a new unit bursting with the newest ideas within a storied pharma? Stefan Oelrich, the head of Bayer’s pharma division, briefly lifted the curtain and spotlighted three key factors as he took the stage on a virtual media day, flanked by Emile Nuwaysir and Sheila Mikhail, the chiefs of BlueRock and AskBio, who each introduced their work in a way you’d expect from a biotech CEO. After decades of failures laid waste to R&D outfits looking to solve the KRAS G12C puzzle, Amgen is as close as anyone ever has been to an approval with sotorasib. For Amgen R&D head David Reese, the drug’s looming review date is a point of reflection for his own career and a big milestone for Amgen’s blooming — if controversial — next-gen oncology pipeline. Amgen filed its FDA application for sotorasib in December to treat metastatic non-small cell lung cancer with the KRAS mutation — once thought to be “undruggable” — months after the agency offered its breakthrough designation based on pivotal Phase I data showing previously unheard of response rates. Taiho and Astex have extended their collaboration with Merck, granting the pharma an exclusive license to their joint SHP2 program. Wednesday’s extension stems from the agreement the three companies signed in Jan 2020. Taiho and Astex will receive an undisclosed option fee and be eligible for further undisclosed milestones and royalty payments. Merck will be solely responsible for the global development of the program and funding all further research. Just over a year after the Supreme Court quashed any hopes Acorda had of protecting its once-lucrative multiple sclerosis drug Ampyra from cheaper knockoffs, the New York biotech continues to bleed cash. Now, as part of its third restructuring since 2017, the drugmaker is offloading one of its key assets. As part of a sweeping overhaul Acorda will sell its manufacturing operations for Inbrija — an inhaled powder formulation of levodopa — to Catalent for $70 million in upfront cash that will save Acorda an additional $10 million. Whatever factors may be limiting the ambitions of Tessera, ready cash isn’t one of them. The startup that debuted in a pandemic, inspired by a new approach to gene editing — perhaps the hottest of all sizzling new biotech trends — and focused on building the next big platform play, has organized a unicorn-hunting global syndicate of backers to fund a hiring spree as they set a course to the clinic.
Pfizer对Vedanta生物科学有直觉。 周二,总部位于马萨诸塞州剑桥的MICROBIOME公司成为第四家获得Pfizer Breakthrough Growth Initiative(PGBI)投资的生物技术公司,投入2500万美元将其Bowel病病情进展到第二阶段。 自六月份启动以来,PGBI已经在中小型生物技术领域投资了1亿2千万美元,这些领域涵盖了以下几个关键领域:内源性医学,免疫和免疫,肿瘤,罕见疾病,疫苗和药物。到目前为止,Homology Medicines公司拥有最大的股份,它的苯酮尿症(PKU)计划有6千万美元。 由于肌肉移植能够重新启动肠道中健康微生物的平衡,Vedanta正在研究细菌菌株的包装,以刺激特异性的过敏反应。该公司表示,辉泽的投资将资助其名为VE202的治疗IBD的live Biotherapeutics的第二阶段试验,预计将于今年推出。 VE202是从纯的,克隆的细菌细胞库中获得的,而不需要直接的FECAL供体meterial。Vedanta说,Topline I期DATA显示VE202总体上是安全的,耐受性好的,并且证明了持久的和剂量依赖性的结肠。 我们相信Vedanta对microbiome的研究可能对IBD患者有希望,随着这项重要研究的进展,我们对它的潜力表示赞赏,Pfizers燃烧和免疫研究部门的副总裁兼CSO Michael Vincent在一份声明中说。 Vincent加入了Vedantas科学广告委员会,Pfizer拥有VE202的首次谈判权。默克公司和艾伯维公司的兽医杰夫瑞·西尔伯在9月加入公司后,将领导Vedantas Efforts担任CMO。 Homology和Vedanta并不是仅有的两家来自马萨诸塞州的生物技术公司。总部位于剑桥的Trillium Therapeutics也为其CD47计划获得了2500万美元的投资。位于英国科隆比亚范库弗市的Essa Pharma公司为其在前列腺癌领域的工作获得了1000万美元的投资。 现在,比以往任何时候都更需要我们,努力把伟大的科学思想转化为创新的新思想,Pfizer在六月的一次演讲中说。 KathyHigh在基因治疗领域重新崭露头角,就像她一年前离开Spark Therapeutics一样出人意料。 她的最新头衔将是AskBio的治疗部总裁,这家生物技术赛马是拜耳公司刚刚斥资20亿现金买下的,目的是在附近建立一个细胞和基因治疗部门。 从表面上看,这种情况与Spark没什么两样,Spark在43亿美元的收购后被罗氏吸收。68岁的High被认为是引导Luxturna批准了一种由RPE65基因突变引起的罕见遗传性眼病,建立了血友病a的基因治疗研究,并领导了血友病B的I/II期试验。 作为生物制药领域的标志性品牌之一,辉瑞在去年决定剥离萎靡不振的Upjohn仿制药业务时,对其内部科学实力进行了一场豪赌。现在,一个更加敏捷的辉瑞正在寻求巩固其未来的身份,但有一件事将保持不变:并购仍然是游戏计划的很大一部分。 随着Upjohn仿制药业务的淡出,辉瑞公司首席执行长阿尔伯特•布拉周二在摩根大通的炉边聊天中说,辉瑞公司正寻求加倍增加其品牌药业务,目标是在继续发展其重磅产品的同时,每年实现6%的年增长率,这在老辉瑞公司是闻所未闻的。 在取得黑色素瘤突破性治疗指定后不到一个月,IO Biotech就获得了超额认购的B系列,这将帮助他们通过后期试验获得免疫调节IDO和PD-L1癌症疫苗。 这家总部位于哥本哈根的公司周三上午透露,这一轮融资净赚1.27亿欧元(1.545亿欧元),从而提高了其T细胞激活疗法的赌注。这是这家生物科技公司自2014年与Novo Seeds合作成立以来最大的一笔融资,当时该公司获得的融资金额比大约4年前的A系列融资高出11倍多。 2018年8月,康奈尔公司的一家小型生物技术分拆公司宣布,他们已聘请辉瑞前高管杰诺·杰尔诺担任首席执行官。然后他们什么也没说。两年了。从字面上看,这家名为Elucida Oncology的公司直到今年10月才发布了一份其他新闻稿,当时他们聘请了一位首席医疗官。 不过,现在,Elucida似乎已经准备好开始揭开他们运营的盖子。周二,在JP摩根,Germano带领投资者参观了他们一直在开发的治疗癌症的纳米粒子技术。同一天,该公司宣布了一项新的融资,在A-1轮融资4400万美元,旨在推动他们在今年进入临床。 到目前为止,拜耳已经用大胆的笔触勾勒出了一些细胞和基因治疗的宏伟计划,并通过对平台公司的巨额收购来巩固这些计划。 但是,在一个有传奇色彩的制药公司里,你如何将一个充满最新创意的新部门拼合在一起呢? 在一个虚拟媒体日上,拜耳制药部门主管斯特凡•奥瑞奇在BlueRock和AskBio的首席执行官埃米尔•努韦西尔和希拉•米哈伊尔的陪同下,简短地拉开帷幕,并强调了三个关键因素,两人都以一个生物技术CEO应有的方式介绍了他们的工作。 经过数十年的失败,试图解决KRAS G12C难题的研发机构付之东流,安进公司与Sotorasib公司的批准几乎如出一辙。对于安进公司的研发主管大卫·里斯来说,即将到来的药物审查日期是他自己职业生涯的一个反思点,也是安进公司正在蓬勃发展的,尽管有争议的下一代肿瘤学管道的一个重要里程碑。 去年12月,安进向FDA提交了索托拉西布的申请,用于治疗带有KRAS突变的转移性非小细胞肺癌,该基因曾一度被认为是不可用药的。几个月前,FDA根据关键的I期数据提供了索托拉西布的突破性名称,显示了以前闻所未闻的应答率。 泰豪和Astex已经扩大了他们与默克的合作,授予默克制药公司独家许可他们的联合SHP2项目。 周三的延期源于三家公司在2020年1月签署的协议。Taiho和Astex将收到一笔未披露的期权费,并有资格获得进一步未披露的里程碑和特许权使用费。默克公司将全权负责该项目的全球开发,并为所有进一步的研究提供资金。 就在最高法院破灭了Acorda希望保护其一度利润丰厚的多发性硬化症药物Ampyra免受更便宜的仿冒品侵害的任何希望一年多后,这家纽约生物技术公司仍在继续榨干现金。如今,作为2017年以来第三次重组的一部分,这家制药商正在出售其关键资产之一。 作为全面改革的一部分,Acorda公司将把Inbrija的生产业务出售给Catalent公司,Inbrija是一种左旋多巴吸入粉制剂,预付7000万元,这将为Acorda公司另外节省1000万元。 无论什么因素可能会限制泰瑟拉的雄心,现成的现金并不是其中之一。 这家初创公司在一场大流行中初露头角,受到基因编辑新方法的启发--或许是所有炙手可热的生物技术新趋势中最热门的一种--并专注于打造下一个大型平台游戏。该公司组织了一个全球独角兽猎头公司财团,在他们确定进入诊所的道路时,为招聘狂潮提供资金。

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